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826 ūüíľ AbbVie Jobs / Employment

Immunology Sales Representative, Dermatology - Chicago South and Central IL - Joliet

newabout 4 hours ago
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Deliver sales performance, brand KPIs, financial targets, marketing objectives, etc. in order to meet or exceed on those objectives. Create pre-call plan using SMART objectives and execute post-call evaluation in order to continuously improve sales performance. Effectively handle objections, misunderstandings, concerns and consistently gain logical and reasonable calls to action in order to close on every sales call. Proactively and continuously aspire to serve customer needs, customer expectations and challenges in order to build trusted customer relationships and to achieve win-win agreements between AbbVie and customers. Develop and execute a call plan that achieves set call metrics and optimizes coverage and frequency to key customers in order to maximize access and sales opportunities. Continuously build understanding on customer needs and expectations, territory market landscape, competitors, market segments/dynamics, accounts, disease, product, clinical and sales expertise and share this market intelligence information with in-field team, brand team and sales manager to achieve alignment, to anticipate environmental changes and challenges and to optimize brand strategy and its execution. Differentiate AbbVie's value proposition with health providers assigned and identify, develop and maintain disease state experts and speakers/advocates in order to maximize brand performance. Bachelor's degree, biological sciences, pharmacy, business related field, or equivalent. Proven track record of success in selling and solid presentation skills. Strong business acumen and proficient use of business tools; possesses strategic and critical thinking capabilities. Proactively identifies customer style / behavior and adapts quickly all aspects of selling approach. Operates effectively in a matrix environment. Offers innovative ideas and solutions to maximize business opportunities to address challenges. Provides impact with ideas for the larger organization and anticipates and responds to changes. Influences others and is viewed as a credible and respected role model and resource among peers. Builds collaborative partnership with district colleagues and matrix team, etc. Position will require overnight travel An essential requirement of your position is to meet health care industry representative (HCIR) credentialing requirements to gain entry into facilities and organizations that are in your assigned territory. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, and proof of immunization/vaccination for various diseases. Preferred: English language proficiency verbally and in writing (for all non-English speaking countries). Preferred: Proven track record of success in sales performance within respective therapeutic areas. Preferred: Commercial pharmaceutical industry experiences such as physician/account based selling, training, managed health care or marketing preferred. Preferred: Demonstrates in-depth scientific, therapeutic, product, and competitive knowledge and is recognized as an expert resource by all relevant stakeholders At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic . Associated topics: administrative, branch manager, director of sales, leader, management, sales director, shift lead, team lead, team leader, territory manager

District Manager, Gastro - Boston - AbbVie

newabout 4 hours ago
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Coordinate in-field activity to achieve results and agreed-upon targets. Maximize market, segment, and team dynamics to drive both top- and bottom-line results. Ensure smooth, collaborative efforts in both day to day and long term business execution. Set tone and pace for business process and organization. Understand and present a market and franchise/business point of view when leading teams and championing in-field meeting by developing a mastery of product and disease state information, as well as pertinent Market dynamics, including Managed Care landscape. Coach, mentor, educate and develop direct and indirect team members to enhance individual skills and elevate overall team performance. Hold direct reports accountable to behaviors and expectations. Provide direction and insights to key internal partners in business planning process. Consistently exemplify the AbbVie Ways of Working. Level of the role will be determined based on candidate experience level Bachelor's Degree. Sales experience. Business analysis and planning skills that drive sales performance. Proven District Manager leadership to include: In good standing with safety and compliance standards. Minimum four years pharmaceutical sales management experience (external management experience can be considered). Is currently meeting performance expectations. Is living the AbbVie Way and effectively demonstrating the Leadership Attributes. Excellent judgment and decision making skills. Ability to articulate the scientific aspects of treatments and therapeutic areas Proven ability to deliver candid, effective feedback and efficiently manage performance. Ability to develop talent for promotional opportunities. Ability to create a culture of winning and full team engagement. Collaborates and is able to influence without authority across organizations. At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Associated topics: analyst, area sales, b2b, b2c, business, business development, business growth, guest, mba, sales

Executive, Health System II

newabout 4 hours ago
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The Health Systems Executive serves as executive liaison between AbbVie and key IDN/ Health Systems while also leading alignment and best practices across multiple geographies through account and sales strategies that may include but are not limited to the followingKey Responsibilities include: Perform all aspects of total account management, including developing and maintaining strategic business relationships with corporate/senior management staff and establishing multi-level relationships with targeted Health Systems as well as broader geographic stakeholders (area and country-wide) with the intent to improve patient population standards of care.Create, implement and communicate strategic and tactical plans for targeted Health Systems /IDNs as well as develop pilot program opportunities around population health/ Standards of Care. Act as a sought after partner to Sales Leaders, Marketing Professionals, and Account Managers, drive account program execution and address regional issues across key CBSAs.Educate and train other Account Managers on strategy and programs.Monitor progress and provide routine communications to all stakeholders. Seeks out and shares knowledge and best practices beyond assigned accounts and geography, with Franchise partners, and with external stakeholders.Developing strategic account plans with clear objectives across AbbVie.Prepares, leads and conducts local account reviews with management teams and Franchise AE/sales team members.Acts as a subject matter expert to all internal/external customers beyond the scope of assigned geography.Demonstrates a complete understanding of client tools, products and disease state knowledge for impactful use with customers and acts as a leader, advisor/expert to field and Home Office team members.Applies financial knowledge to be a resource and mentor in development of programs.Partners across channels, franchises and/or with national level account managers to identify partnering and program opportunities; addresses gaps and/or problems through defined action plans that have regional and potentially national impact.Draws on experience from other geographic areas and industries to create and manage CBSA opportunities through collaboration with other Franchise AEs. Creates CBSA plans and strategies around their targeted Health Systems.Ensure all engagement activities within an account are coordinated and all team members are informed of goals and objectives.Communicates higher level account needs and priorities to marketing and franchise teams for input into value propositions.Acts as a consultant in emerging market channels and with new stakeholders. Rapidly evaluates new opportunities, identifies short and long-term implications and defines plans that achieve business goals.Consistently and independently takes a leadership role/defines accountability for broader geographic success; align teams around common goals and sets plans to achieve objectives.Leads identification and design/adaptation of initiatives through analysis of data (quantitative and qualitative); recommend solutions to benefit the broader organization.Drives implementation and communication across Franchise account teams to align efforts and define innovative account management approaches.Leads committees/task forces and represents AbbVie on local, regional and national levels. Acts as a consultant and mentor in conveying key learnings and opportunities.Provides leadership and expertise to Field Sales (RMs/ DMs and Franchise AEs) and Marketing teams for CBSA plan execution around key Health Systems.Develops pilot programs and shares results with counterparts; works as a consultant to replicate successful programs in other geographies.Builds upon and maintains established customer relationships that are active partnerships; is consistently seen as a competitive advantage to the customer, key source of programs and solutions that drive the business for the customer.Leverages existing customer relationships across a broad foundation of accounts and coalitions/stakeholder groups to benefit other cross-divisional franchise partners.Defines gaps in resources and tools; create/influence the creation of needed resources to achieve objectives.Ensure all activity is ethical and compliant.On average, an HSE covers a geography that includes 5-8 targeted IDN/Health Systems/ACOs and is accountable for supporting colleagues across Managed Care and Franchise teams to define practices and programs that drive improved population health in areas of interest to AbbVie.The HSE has a broad range of responsibilities including designing programs that align with Health System business needs/expectations, integration of Managed Care strategies to result in improved patient care in various diseases. HSEs will act as quarterback across AbbVie franchises for their target accounts at the headquarters level focusing on key Health Care Leaders. The HSEs are responsible for establishing key business relationships internally as well as being a representative of AbbVie externally, enhancing the image of AbbVie as a healthcare industry leader in bringing patient care solutions to entire populations. Health Systems Executives report into a Regional Manager and have responsibility for effectively managing program and project budgets. Bachelor's Degree required driving business strategies and plans within assigned accounts.Proven track record of managing multiple stakeholders within a geography/territory.Strong business acumen; analytical ability to analyze diverse sets of data using multiple tools and define account/program strategies that drive business objectives.Must demonstrate an understanding of how to maintain/increase market growth, forward-thinking, innovative strategies that align with AbbVie and customer objectives.Effectively demonstrate leadership skills; ability to lead without direct authority. Has experience with successfully leading diverse teams on complex projects or challenges to achieve results.Excellent communication and presentation skills.Preferred: MBA preferred.3 years sales management (District Manager) strongly preferred.Account management or marketing experience in a healthcare or related business; managed care, government channel experience is preferred.Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.Account Management experience in the MN/Dakotas markets preferred. Key Leadership Competencies: Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.Learns, fast, grasps the \"essence\" and can change the course quickly where indicated.Raises the bar and is never satisfied with the status quo.Creates a learning environment, open to suggestions and experimentation for improvement.Embraces the ideas of others, nurtures innovation and manages innovation to reality.At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Associated topics: diet, dietetic, dietician, healthcare, immunoassay, microbiology, nutritionist, pharmacy, therapy, transfection

Senior Medical Director - Pulmonologist - North Chicago

newabout 4 hours ago
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Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff.Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs).Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings.Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.At least 5 years (7 years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.Ability to run a complex clinical research program independently.Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.Ability to interact externally and internally to support a global scientific and business strategy.Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols. At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Must possess excellent oral and written English communication skills.Ability to exercise judgment and address complex problems and create solutions for one or more projects. Associated topics: demand, endowment, event, facebook, festival, market, mba, policies, public relations, stewardship

Medical Science Liaison, Immunology/Gastroenterology, CO - Denver

newabout 4 hours ago
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The Medical Science Liaison (MSL), is a field based scientific expert that strategically supports the scientific and business objectives of a designated therapeutic area across the product life cycle. MSLs are the primary communicators of AbbVie science within a specific geography with healthcare professionals. MSLs are the field scientific experts on given disease states and treatment options within a designated therapeutic area. They combine strong business acumen, clinical expertise, market awareness, and serve as a conduit of information both externally and internally to a cross functional customer base internally within AbbVie. Based on therapeutic needs and product life cycles, teams may focus on certain responsibilities to a greater or lesser degree, including clinical development and pipeline support. This is the entry level MSL position in which the individual contributor will learn the capabilities and responsibilities of the role within the AbbVie landscape. Responsibilities Include: Develops, executes and maintains high impact territory plans, including HCP and Investigator engagement plans in alignment with therapeutic area medical and scientific objectives with a focus on quality. Uses data and analytics to seek out and maximize opportunities within their territory. Identifies, gains access to, and develops professional customer centric based relationships with external experts (EEs) in therapeutic areas within assigned geography. Delivers on territory plan objectives, meets assigned project deadlines, and achieves annual functional goals. Generates and documents meaningful data point observations (DPOs). Practices core capabilities in Segmentation, DPOs, as well as Optimal Resource Utilization, including financial decisions. Responsible for compliance with applicable Corporate and Divisional Policies and Procedure, including accurate and timely documentation as it relates to HCP interactions. Scientific Resource to External HCPs and other Stakeholders Provides education relative to disease state, therapeutic landscape and AbbVie products across the product lifecycle to healthcare providers and researchers. Therapeutic Disease State, Landscape, and Asset Expert Continually educates self on market issues/trends, product knowledge, and new therapeutic areas of interest as it pertains to specific business responsibilities, including creating awareness and relationships for AbbVie in the Medical community. Supports research initiatives across development at the request of R&D to include, but not limited to, site evaluation and identification, recruitment, investigator meetings, external expert identification, and external collaboration management. Maintain Cross-functional Field Partnerships Creates, maintains, and collaborates in relationships with Cross-Functional partnerships, including, but not limited to in field teams, , engagement with site management and monitoring and clinical research associates, the Therapeutic Area, and with the Medical Outcome Science Liaisons. Works with in-field teams, as appropriate, to develop and execute Account plans designed to support and meet shared business objectives. Serves as a scientific resource to commercial partners as appropriate to support activities such as Medical Congress staffing and training initiatives. Bachelor's degree in the health sciences from an accredited university required. Advanced medical degree preferred in a relevant scientific discipline. Doctorate strongly preferred in a health science or clinical discipline. Significant clinical and/or industry experience in relevant therapeutic area may be accepted in lieu of education requirements. Greater than or equal to 2 years of clinical, scientific/research, or industry related experience or equivalent preferred. The MSL must possess problem solving and analytic skills to be able to identify, and translate specific territory and corporate needs, into an action that will achieve objectives. Exhibits leadership attributes that align with company-wide initiatives such as: All for One AbbVie, Clear and Courageous, Make Possibilities Real, Agile and Accountable, and Decide Smart and Sure. Possesses foundational skills in Scientific Storytelling, Identifying Mobilizers, Medical Challenger, and Active Listening. An essential requirement of the position is to meet health care industry representative (HCIR) credentialing requirements to gain entry into facilities and organizations that in your assigned territory. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, and proof of immunization/vaccination for various diseases. Must be willing to travel up 75% of your time From Denver area Equal Opportunity Employer Minorities/Women/Veterans/Disabled Associated topics: biopharma, dietetic, drug development, healthcare, histotechnologist, patient, pharmacology, pharmacy, protein, trauma

Associate Research Technician, In Vivo Biology (Vivarium) - San Francisco

newabout 5 hours ago
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Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products - Imbruvica, Venclexta, and Empliciti - and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer. AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position is based at Stemcentrx, AbbVie's South San Francisco, CA location. AbbVie Stemcentrx is looking to hire a highly motivated team player who will join the team that supports early stage research and development. The qualified candidate must have strong interpersonal and communication skills, have a strong commitment to providing research support, and dedicated to providing humane animal care in accordance with the animal welfare regulations and local regulations of the IACUC. The candidate must be very reliable, be able to work independently or in a group setting that is dynamic and fast paced, be very focused and attentive to details and be able to provide high quality and consistent results.Key Responsibilities Includes: Supporting discovery research by ensuring the highest quality of animal care / husbandry and facility management. Husbandry work includes daily recording of room environments, daily animal health checks and reports, weekly cage changes, stocking of supplies and supporting in Vivo research staff. Must be willing to work weekends and holidays on a rotational basis, be able to lift 50 pounds, be willing to stand for long periods of time and be flexible in working longer hours. A.S. Degree in Biology or related discipline Minimum 1-3 years of directly related experience. AALAS certification is preferred but not required Ability to multitask and meet deadlines in a fast paced environment Ability to perform occasional physical labor involving lifting weight up to 50 pounds Willing to split weekend and holidays with peers on a rotational basis Excellent verbal and written communications skills Motivated to excel, learn, attentive to details Efficient in working alone or in a group environment. Equal Opportunity Employer Minorities/Women/Veterans/Disabled Associated topics: aseptic, bacteria, biology, biostatistics, biotechnology, genome, neurobiology, pathophysiology, physical, protein

Contract Analytics Supervisor - North Chicago

newabout 6 hours ago
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AbbVie has a strong specialty product portfolio that serves patients in the areas of Immunology, US Specialty, and Oncology, with new specialty medications in development. A cross-therapeutic team within the Market Access organization specializes in working with channel partners to provide access, services and resources to ensure optimal patient care.KEY RESPONSIBILITIES INCLUDE:Le ad ConTRAX contract management system processes including preparation of required legal documents, fair market value, redline process, pharmacovigilance, purchasing documentation, vendor setup and management, and purchase orders. Track program expirations and spending limits and prepare analysis to support recommended contract amendment.Supervise contract flow and identify and set up team meetings to resolve bottlenecks.Participate in Plan preparation, LBEs, LRPs, Link-IT, prepare monthly budget trackers, and set up program budget reviews in advance of periodic finance reviews.Analyze and interpret monthly invoice data, summarize results, and clearly and persuasively communicate findings, implications and program recommendations verbally and in writing including communications with contract managers, program managers, account executives, and our Trade partners.Prepare, distribute, and maintain monthly chargeback and other ad hoc data reports.Ensure all contracts prior to finalization meet company requirements related to Corporate policies, FMV, OEC monitoring, PV, and final-approved redline. Track results, prepare documentation, and maintain compliance monitoring program. BA or BS required. Degree concentration in business administration, marketing, or finance is a strong plus.Minimum 3 years related contract experience, with at least 2 years on the client side.Strong analytical and problem-solving skills.Excellent interpersonal and communications skills (both verbal and written).At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Associated topics: business, compliance department, compliance office, corporate attorney, counsel, court, courtroom, legal, legal affairs, market

Senior Scientist I, Pharmaceutical Development, CMC Biologics

newabout 6 hours ago
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Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products - Imbruvica , Venclexta , and Empliciti - and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer. AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position will be based at AbbVie Biotherapeutics, AbbVie's oncology research site in Redwood City, CA. Senior Scientist I, Pharmaceutical Development, CMC Biologics We have an exciting opportunity available for a Senior Scientist I within the Pharmaceutical Development Group in the CMC Biologics department at AbbVie, Redwood City, CA. AbbVie at Redwood City is an R&D organization focused on development of innovative biologics in the field of Oncology. This position will support CMC drug product development for oncology pipeline that include mAbs, ADCs, and novel bispecific antibody formats, through clinical proof-of-concept. Key responsibilities: Develop preclinical and clinical formulations, including liquid and lyophilized dosage forms, and related drug product manufacturing processes Transfer drug product manufacturing process to internal and external fill-finish facilities and provide on-site support as needed Responsible for stability testing of representative lots and clinical in-use studies to guide dose solution administration Generate high quality data based on sound scientific principles and prepare formulation data summaries, technical reports, scientific presentations and regulatory documents Actively participate in drug product development teams and contribute to the planning and execution of product development studies including formulation and drug product process development, based on project goals and timelines Actively interact with CMC members and other AbbVie stake holders to enable successful development of AbbVie drug products Drive innovation by investigating and developing novel experimental approaches and/or technologies in the field of drug product development, and raise visibility within the scientific community through external presentations and publications EDUCATION and/or EXPERIENCE Ph.D in pharmaceutical sciences, chemical engineering, analytical sciences or equivalent field with 0-3 years of experience or BS/MS degree with 8-10 years of relevant experience in the biotechnology or pharmaceutical industry. A strong technical background encompassing protein chemistry, analytical development, and formulation development is required Candidates must have hands-on expertise in analytical techniques used for protein characterization and stability testing Prior experience in development of protein product formulations and lyophilization expertise is highly desirable Demonstrated experience in driving innovation is a strong plus Prior experience with aseptic processing, and drug product manufacture processes transfer is preferred Excellent communication and written skills required At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Associated topics: aseptic, drug, health, histology, immunoassay, industrial hygienist, kinesiology, medical, medicine, transfection

Senior Principal Research Engineer - Human Factors - AbbVie

newabout 6 hours ago
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This role is intended to support the CPD HF group's need to manage projects to design, test and validate pharmaceutical delivery devices. This individual will work alongside existing AbbVie HF, Engineering, Medical, Legal and Regulatory staff in determining the types of HF studies that are required in designing for ease-of-use, safety, customer acceptance, and regulatory approval. The individual will perform the following functions in partnership with third-party HF firms: Perform task and workflow analyses Design and conduct contextual inquiries Work with System Engineer to develop user requirements and user interface documentation Conduct and evaluate Use Related Risk Assessments, recommend and evaluate design mitigations Design and conduct usability tests and other usability assessments Design, conduct and analyze interviews and surveys Compile thorough documentation for inclusion in regulatory submissions Other Functions: Assist in training internal staff to perform some HF functions under supervision Assist in maintaining corporate policy, procedures and tools on best practices for HF Facilitate the selection and proper use of outside HF consultants MS in Human Factors, Industrial Engineering, Human Computer Interaction, Psychology or equivalent Strong working knowledge of Human Factors methods and principles. 5-10 years' experience in design and evaluation of usability studies Excellent written and spoken communications skills Ability to work with a variety of disciplines and teams in fast-paced environments Strong problem-solving and analytical skills Experience in pharmaceutical or medical device product development is required Working knowledge with medical devices and medical device regulations and standards is required At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic . Associated topics: anthropology, chinese, french, historian, humanity, legal, mexican american studies, pashto, social, theology

Sales Representative, HCV - Ventura County - Fresno

newabout 7 hours ago
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Deliver sales performance, brand KPIs, financial targets, marketing objectives, etc. in order to meet or exceed on those objectives. Create pre-call plan using SMART objectives and execute post-call evaluation in order to continuously improve sales performance. Effectively handle objections, misunderstandings, concerns and consistently gain logical and reasonable calls to action in order to close on every sales call. Proactively and continuously aspire to serve customer needs, customer expectations and challenges in order to build trusted customer relationships and to achieve win-win agreements between AbbVie and customers. Develop and execute a call plan that achieves set call metrics and optimizes coverage and frequency to key customers in order to maximize access and sales opportunities. Continuously build understanding on customer needs and expectations, territory market landscape, competitors, market segments/dynamics, accounts, disease, product, clinical and sales expertise and share this market intelligence information with in-field team, brand team and sales manager to achieve alignment, to anticipate environmental changes and challenges and to optimize brand strategy and its execution. Differentiate AbbVie's value proposition with health providers assigned and identify, develop and maintain disease state experts and speakers/advocates in order to maximize brand performance. Bachelor's degree, biological sciences, pharmacy, business related field, or equivalent.Proven track record of success in selling and solid presentation skills. Demonstrates in-depth scientific, therapeutic, product, and competitive knowledge and is recognized as an expert resource by all relevant stakeholders. Strong business acumen and proficient use of business tools; possesses strategic and critical thinking capabilities. Proactively identifies customer style / behavior and adapts quickly all aspects of selling approach. Operates effectively in a matrix environment. Offers innovative ideas and solutions to maximize business opportunities to address challenges. Understands and leverages findings to develop sales strategies. Provides impact with ideas for the larger organization and anticipates and responds to changes. Influences others and is viewed as a credible and respected role model and resource among peers. Builds collaborative partnership with district colleagues and matrix team, etc. Leads by example; Consistently displays positive behaviors and peer coaching through changing and challenging environments. Documented success in leadership and support role of increased responsibility at the district, region and/or organizational levels. An essential requirement of your position is to meet health care industry representative (HCIR) credentialing requirements to gain entry into facilities and organizations that are in your assigned territory. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, and proof of immunization/vaccination for various diseases Preferred: Proven track record of success in sales performance within respective therapeutic areas. Commercial pharmaceutical industry experiences such as physician/account based selling, training, managed health care or marketing preferred. English language proficiency verbally and in writing (for all non-English speaking countries). Associated topics: administrative, branch manager, management, manager of sales, regional sales manager, sales leader, sales manager, shift lead, supervisor, team lead

2019 Experiential Internship Program - Undergraduate Level - North Chicago

newabout 7 hours ago
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Experiential Internship OverviewThe AbbVie Experiential Internship Program (EIP) is a paid, ten to twelve-week summer opportunity that is focused on providing students with robust projects, based on business need. You'll do meaningful work that has a real impact on our business and patients worldwide. Possible internships are in the following areas (but not limited to): CommercialDrug DiscoveryDrug Product DevelopmentGovernment AffairsManufacturing Science, and Technology (MS&T)PackagingPharmacovigilance and Patient Safety (PPS)Regulatory Affairs (RA)Regulatory Quality Safety (RQS)Supply ChainExperiential interns will be located at our corporate headquarters in north suburban Chicago. Throughout the summer, there are planned development and networking activities, along with AbbVie-sponsored housing and shuttle services for eligible students.*Applications to the Experiential Internship Program will be collected throughout the fall semester. If there is interest in your resume, a recruiter will reach out to you in the November - March time frame for information regarding next steps. Basic Requirements Enrolled in an undergraduate level program at an accredited universityStrong academic performance, minimum cumulative GPA = 3.0/4.0Completed at least one year of college education before beginning internshipMust be enrolled in school the semester following your internshipPreferred Requirements Prior internship/research experienceExceptionally demonstrated interpersonal skillsProven leadership skillsDemonstrated oral and written communication skills Equal Opportunity Employer Minorities/Women/Veterans/Disabled Associated topics: accountant ii, accountant iii, administrative, administrative assistant, analyst, information technology support, information technology systems analyst, public relations specialist, support, workshop

Senior Scientist III, Chemical Engineering - AbbVie

newabout 7 hours ago
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Process Research and Development invents chemical processes and prepares active pharmaceutical ingredient (API) to enable clinical trials, toxicology studies and drug product development for AbbVie's pre-clinical and clinical drug pipeline. In addition to working with small molecules, Process R&D also develops antibody drug conjugates (ADC). We create valuable intellectual property through composition of matter, chemical processes and technologies resulting in cost effective commercial manufacturing processes. We develop the supply chain for APIs, prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content. Chemical Engineers in AbbVie's R&D work in multi-functional teams to develop scalable processes and supply API for safety testing, clinical trials and formulation development. The teams include Process Chemistry, Pilot Plant Operations, Analytical Chemistry and Solid State Chemistry. Chemical Engineers support API projects through all phases of development. Early in development, engineers focus on ensuring the process can be run safely, identifying and addressing major scale-up issues and developing the final (API) process step. Later in the development process, engineers optimize the API process and lead process campaigns run in the R&D Pilot Plant. In the final stage of development, engineers transfer the optimized process to manufacturing and support process validation. Job Description: The successful candidate will play a key role in the Process Chemical Engineering function within Process R&D. Develop robust commercial processes to manufacture small molecule APIs and ADCs. Address challenging problems in chemical reactions, extractions, distillations, crystallizations, filtration and drying to meet the target chemical and physical property attributes of the product through an in-depth scientific assessment of these unit processes/operations. Expected to lead identification and development of novel approaches and technologies to enhance efficiency in process development and commercialization. Must exhibit a collaborative nature in identifying process challenges on a wide range of projects, and take on a leadership role in developing and implementing solutions. *Level and compensation will be commensurate with experience.* Basic: BS, MS, PhD in Chemical Engineering with 14 (BS), 12 (MS), or 6 (PhD) years of experience Strong background in the design and development of chemical engineering unit operations and processes. Must possess at least 3 years of demonstrated pharmaceutical development experience and familiarity with various process analytical technologies (PATs). Key Leadership Competencies: Builds strong relationships with peers and cross functionally with partners to enable higher performance. Learns fast, grasps the \"essence\" and can change course quickly where indicated. Raises the bar and is never satisfied with the status quo. Creates a learning environment, open to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality. Strong interpersonal and communication skills with demonstrated ability to work within a team environment. Equal Opportunity Employer Minorities/Women/Veterans/Disabled Associated topics: chemical, chemistry, engineer, fuel, gas, natural gas, petrol, petroleum, petroleum and chemical, petroleum engineer

Senior Principal Engineer

newabout 7 hours ago
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Responsibilities of this engineering grade level inherently include and expand upon the responsibilities established for lower engineering grade levels within technical consultant career track.Responsible for compliance with applicable Corporate and policies and procedures. Ensures quality and effectiveness of key results of major projects within function through sound design, early risk assessments, and implementation of fallback strategies. Has full awareness of the potential consequences (defects and failure modes) of design changes to established processes. Mitigates risk within functions through sound design, early risk assessments and implementation of fallback strategies.Identifies, plans, and conducts medium- to large-size projects across engineering disciplines requiring custom, risk-managed execution plans, investigations, and/or equipment. Makes difficult decisions regarding priorities between projects. Responsible for achieving the project's financial targets in support of business objectives and life cycle costs.Serves as organization spokesperson on advanced projects and/or programs. Acts as advisor to management and customers on advanced technical research studies and applications. A Bachelors Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 10 years of significant engineering and/or operational experience. A post-graduate education/degree is desired, and may contribute towards the desired years of experience.Has demonstrated excellence in breadth and depth within discipline and across disciplines.Has a career history marked by a consistent series of technical contributions and accomplishments. Significant contribution to product or process development or improvement through creative application of technical effort will equally be recognized.Possesses a strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Exercises judgment and advises management as to the appropriate actions.Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.Works well with other engineers in a collaborative, fast-paced goal-driven environment.Possesses interpersonal skills to negotiate and reconcile differences.Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries (preferred).Has demonstrated competency with financial systems and in fiscal control.At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Associated topics: bio, biological engineer, biology, biomaterials, enzyme, medical, msat, neuroscience, nutrition, therapeutic

Scientist I/II, Histologist, Neuroscience - Cambridge

newabout 8 hours ago
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AbbVie is investing heavily in a new research enterprise in Cambridge, Boston - the Foundational Neuroscience Center (FNC). The FNC will investigate the fundamental biological mechanisms underpinning neurodegenerative disease, especially Alzheimer's disease.We are seeking an experienced, lab based Scientist with expertise in Histological analysis to join the In Vivo Pharmacology team at the FNC. This individual will be responsible for providing ex vivo support for variety of in vivo studies in animal models including target identification, target validation and efficacy for Alzheimer's disease and Parkinson's disease drug discovery projects. Key Responsibilities Includes: Working closely with team members to design and execute in vivo experiments with histological endpoints Developing new technologies and methods to understand disease pathophysiology and target biology Responsible for data collection, interpretation/analysis and presentation as needed Position will be hired based on level of experience. BS in biology or related field with 5-7 years of neuroscience-related experience or MS with 2-5 years of experience Experience doing histology, immunohistochemistry and image analysis required Experience doing paraffin histology (processing, embedding, sectioning) and/ or frozen (sliding microtome, cryostat) required Prior experience working with automated IHC/staining system (e.g. Leica BOND) preferred In vivo skills including animal handling, dosing and tissue collection preferred Outstanding organizational skills and excellent verbal/written communication skills required Associated topics: biopharmaceutical, disease, drug, food, health, healthcare, pharmacology, pharmacy, therapeutic, virus

Sr. Manager/Principal Statistician, Oncology Early Development

newabout 9 hours ago
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Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products - Imbruvica, Venclexta, and Empliciti - and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer. AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. We have an exciting opportunity for a senior level statistician (level and position title commensurate with experience) reporting to Director, Statistics. There is flexibility for this position to be based at our South San Francisco (CA), Redwood City (CA), or Lake County (IL) location.Position Description Provides scientific and statistical expertise for drug discovery or development strategies for assigned project in early-stage oncology; for the design, analysis, and reporting of scientific research trials; and for interacting with regulatory agencies regarding the results of these activities. Protocols: Directs the development of scientific protocols, ensuring they are scientifically sound and make optimal use of the data to be collected Ensures research hypotheses and corresponding study designs are aligned with the project strategy, and meet scientific and/or regulatory needs Ensures statistical methodology is appropriate and sound, consistent with the objective(s) of the scientific protocol Database Activities: In collaboration with Data Sciences, Statistical Programming and other stakeholders, ensures data collection instruments are designed to capture protocol-specified scientific information and study databases (e.g., SAS, MS Access, Excel) are implemented such that short- and long-term project needs can be achieved Oversees or partners in development of data quality assurance checks, ensuring accuracy and consistency of data released for statistical analysis Statistical Analyses: Demonstrates extensive understanding of statistical concepts and methodologies Proposes new/novel statistical methodological approaches leading to improvements in the efficiency and sensitivity of study results Provides sufficient detail to allow programming implementation Ensures that all the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately Scientific Reports and Publications: Ensures that study results and conclusions are scientifically sound, clearly presented, and supported by the statistical analyses provided Prepares oral and written reports to effectively communicate results of clinical/scientific research to AbbVie management, project teams, regulatory agencies, or individual investigators Provides in-depth scientific/statistical review for scientific reports and publications Consultation: Works collaboratively with members of multi-function teams to complete project deliverables per agreed timelines. Keeps management informed on important scientific/statistical issues that may arise, in a timely manner. In collaboration with Statistical Programming or their designee, ensures that all programs meet analysis requirements, internal standard operating procedures, validation, and external regulatory requirements. Communicates with statisticians outside AbbVie concerning technical issues, building external scientific contacts, fostering professional development, and promoting the reputation of the department. Effectively and persuasively presents statistical concepts, evidence, assessment of risks and impacts, and logical arguments to management, regulatory agencies, and scientists. Demonstrates an understanding of drug development principles for assigned projects. Project Team Involvement: Represents Data and Statistical Sciences (DSS) or Biometrics on assigned project team(s) to provide functional area input to compound/drug development. Serves as a liaison between the project team and DSS or Biometrics to ensure timely communication of project team updates, proper statistical strategies, and alignment of priorities between the project team and functional area. Training, Supervising, Mentoring: Mentors junior staff and other development stakeholders with regards to statistical methodology and departmental operations Participates in department seminars, short courses, and the publication presentation of scientific articles Participates in departmental activities including recruiting, training/mentoring, research efforts, and cross-functional collaborations, as needed. Regulatory Activities: Participates with DSS or Biometrics management in discussions with corresponding technical personnel from regulatory agencies and with investigators concerning proposed or ongoing studies. Senior Manager: PhD in statistics or related field with 4-6 years or MS in statistics or related field with 8-10 years of work experience in pharmaceutical development and applied statistics/statistical consulting required Principal Statistician: PhD in statistics or related field with 8-10 years or MS in statistics or related field with 12 years of work experience in pharmaceutical development and applied statistics/statistical consulting required. Project lead experience required. High degree of technical competence and effective oral and written communication skills. Competent in experimental design, statistical modeling and inferential statistics; actively seeks to acquire knowledge concerning the use of new/novel statistical techniques and their biometric/ biopharmaceutical applications. Pharmaceutical or related industry experience with clinical studies, including experience and understanding of drug development in the regulated environment preferred. Experience in oncology is highly preferred; experience in early development (Phase 1) is highly preferred. Ability demonstrating strong cross functional team work is required; must be able to work in a fast paced environment and change course when needed At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Associated topics: ancmg, breast, cancer, hem onc, lah, palliative, physician md, physician md do, radiation, thedacare

Business System Consultant

newabout 9 hours ago
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AbbVie's Supply Chain BTS (Business Technology Services) organization is helping to transform the business by connecting information from packaging lines to patients through new and enhanced Digital Supply Chain capabilities. This is an exciting opportunity to be part of that change. The Supply Chain Business Systems Consultant provides advice, assistance and leadership in any area associated with the planning, procurement, provision, delivery, management, maintenance and effective business use of information systems for a business area. Analyzes business processes; elicits, analyzes and documents business requirements; identifies alternative solutions, assesses feasibility and makes recommendations typically seeking to exploit and leverage new or existing technology components. Translates business requirements into functional requirements; performs data and process modeling; manages change; and leads, coordinates/performs testing, verification, and validation of requirements. Key Responsibilities Include: Works directly with business unit clients to understand specific business processes and business drivers and business strategy across multiple business units; identifies and communicates resulting needs and opportunities for business process improvement that can be enabled via technology. Investigates and understands capabilities of existing systems and technologies already in use across the business area and similar and interconnected business areas in AbbVie and investigates available technologies applied to this business area in industry; identifies information required to support the business strategy and leads the development of appropriate information management strategies, developing them as an integrated part of the business strategy. Assists Supply Chain Domain Architect with Digital Supply Chain framework and roadmap designs and solutions development and implementation. Identify and drive opportunities for cross-supply chain system efficiencies and data handling and quality. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Identifies current and emerging business needs and evaluates alternative technology solutions using standard information systems methodologies and best practices. Proactively seeks out strategic business opportunities for the application of new or existing technology capabilities (across multiple business areas) with high-level business unit executives providing key opinion-leading clients with comprehensive strategic analyses and insights to help them discover strategic uses of technology products and services. Develops, leads, or reviews the creation of information systems strategy to support the strategic requirements of multiple business areas. Identifies the business benefits of alternative strategies. Ensures compliance between business strategies and technology directions. May prepare testing plans to confirm that requirements and system design are accurate and complete. Conducts training.Makes recommendations to process stakeholders regarding the correct approach to achieve process improvement objectives. These may include business process outsourcing, application development or adopting business process management (BPM) practices. Develops business relationships and integrates activities with other BTOs to ensure successful implementation and support of project efforts. Manages relationships between clients involved and BTOs to assure effective communication between the groups is occurring. Brokers services within BTS on behalf of customers; coordinates portfolio of solutions, and identifies interdependencies. Allies with other BTOs to remain current on project status, and inform customer management of progress; conversely, keeps BTS managers aware of user issues and resolves conflicts. Identifies the impact of any relevant statutory, internal or external regulations on the organization's use of information. Has defined authority and responsibility for a significant area of work, including technical, financial and quality aspects. Establishes organizational objectives and delegates assignments. Accountable for actions and decisions taken by self and subordinates. Accountable for the accuracy of the fit of the proposed business process improvements and the technical solution to the business needs and the information upon which the business justification and prioritization decisions are made. Also accountable for communicating the business need and drivers to development groups to assure the implementation phase can fulfill the business need. Basic: Bachelor's Degree, or an equivalent combination of education and work experience, Computer Science preferred 10-12 years of related work experience. Exercises latitude in the approach to problem solving. Determines and develops approach and solutions to problem Experience with offshore/onshore/near shore resources Pharmaceutical industry experience preferred, preferably Supply Chain Demonstrated ability to learn, understand, and master new technologies such as Blockchain and IoT Serialization / Track and Trace experience a plus Equal Opportunity Employer Minorities/Women/Veterans/Disabled Associated topics: business, business analyst, business systems, business systems analyst, consultant, customer, market, marketing, sales, senior consultant

Director, Regulatory Affairs, Oncology Early Development - Redwood City

newabout 9 hours ago
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Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products - Imbruvica , Venclexta , and Empliciti and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. AbbVie is also expanding their expertise through partnering with companies leading the way in emerging biologic technologies including oncolytic virus' and CAR-T cells.The Director, Regulatory Affairs will develop and implement global regulatory strategies to support the development of multiple oncology early development assets. This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables. This position is based at AbbVie in the Redwood City, CA location.Key Responsibilities Include: Develop and implement competitive and effective global regulatory strategies for various oncology products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies Manage and participate in the creation, review, assembly and submission of regulatory documentation such as INDs and its international equivalents, expedited program designations, orphan drug applications, annual reporting, pediatric plans, and amendments related to clinical trials Coordinate and consult with subject matter experts on the content, review and publication and assembly of regulatory documentation Serve as primary Health Authority contact for assigned projects Provide advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and review processes. Present global regulatory strategies and issues at team or governance meetings Collaborate with regional and country regulatory affiliates to support international development activities Coordinate and prepare for Health Authority meetings and associated briefing document preparation Attend relevant functional area and project team meetings, including nonclinical, clinical, and regulatory sub teams Bachelor degree in a life sciences, chemistry, or related discipline. Advanced degree preferred 8 to 12 years of experience in Regulatory Affairs (minimum 4 years within oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment. International regulatory experience required Knowledge of current US and EU regulations for oncology drugs, including experience preparing, filing, and performing life-cycle management of applications and all supportive amendments, supplements, and annual reports to the United States Food and Drug Administration (US-FDA) in eCTD format Knowledge of oncology global clinical trial regulations, including experience with submission of Clinical Trial Applications (CTAs) to global regulatory agencies and management of regulatory aspects of clinical trials in accordance with Good Clinical Practices (GCP) requirements Experience in submissions of Proposed Pediatric Study Request (PPSR), deferral requests, study protocols and clinical study reports (CSRs) Experience with health authority meeting preparation Proven ability to independently manage critical projects as part of an interdisciplinary team. In addition, the candidate should have experience preparing, managing and submitting major regulatory submissions. Ability to successfully manage multiple projects to deadlines Experience with regulatory intelligence activities and pharmaceutical registration databases to support product approval strategies At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Associated topics: aoa, breast, cancer, hem onc, hematology, lah, oncology, palliative, physician md do, thedacare

Associate Medical Director, Physician Development Program - Dermatology

newabout 9 hours ago
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A two-year rotational leader development program for physicians to gain experience in 5 different areas: Clinical Pharmacology, Medical Affairs,Clinical Development, Regulatory Affairs and Pharmacovigilance and Patient Safety. With supervision, participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy. Provides scientific and technical support for assigned products; delivers scientific presentations; develops and maintains professional and credible relationships with key opinion leaders. Key Responsibilities Includes : With appropriate supervision, manages the design and implementation of study protocols for a development program in support of the overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff. Has responsibility for oversight of clinical studies, monitoring overall study integrity, review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Participation in design and execution of clinical trial safety, product safety and risk management plans. Responsible for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE's) and Serious Adverse Events (SAE's) if assigned to AbbVie conduct on clinical studies. Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. May interact with and coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc...) as they relate to ongoing medical affairs projects. May assist as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities. May assist in scientific/medical education of investigators, clinical monitors, and Asset Development Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements. May represent the medical function on cross-functional integrated teams for medical affairs activities. May represent AbbVie at external meetings including investigator meetings, scientific association meetings, etc. May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. May assist with the scientific review, development, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities. Exercises judgment within well-defined practices and policies. Typically does not supervise employees but must be able to influence in a matrixed environment. Works with some supervision and guidance. Medical Doctor (M.D.), Doctor of Osteopathic Medicine (D.O.) or international equivalent medical degree that meets U.S. certification standards Completion of U.S. residency training U.S. board eligibility or certification (U.S. State or Commonwealth licensure U.S. Citizen or Permanent Resident Preferred: Medical specialty training in any of the following or related therapeutic areas: Dermatology Fellowship training, associated with clinical research Additional healthcare/research academic degrees, including PhD or MPH A commitment to pursuing a career in clinical research Experience publishing research Demonstrated leadership skills Strong verbal/written communication skills Effective presentations skills Demonstrates critical thought processes and analytical skills Equal Opportunity Employer Minorities/Women/Veterans/Disabled Associated topics: administrative, administrative officer, administrative staff, administrative support, assist, beverage, chief operations officer, operations director, staff, support

Senior Clinical Safety Analyst - AbbVie

newabout 10 hours ago
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Participates in applicable safety surveillance activities for assigned products; and in planning and completion of Ad-Hoc Safety Reports as needed. Timely assessment of adverse event coding for consistency and accuracy of coding and ; accurate and effective medical review of safety-related CRFs and labs, including communication with Study Designated Physicians by interfacing with study manager, Clinical Research Organizations, Clinical Research Associates, Data Management, Pharmacovigilance and others to assure query resolution. Supervise tracking of safety -related queries to Investigators and assists in handling safety questions from IRB/IEC. Assist with Study Safety Review Plan development and implementation in collaboration with Study Designated Physicians and provides Safety overview to Clinical team members, Clinical Research Organizations, Investigators and investigator sites as needed and review study protocols, IND reports, annual reports, Investigator Brochures, Safety sections of the Clinical Reports, Monitoring Plans, IDMC data and other ad hoc reports which include safety data. Create narratives of serious adverse events and other identified events of interest in accordance with accepted standards and with high degree of competency. Apply knowledge of ICH, FDA, EMA regulations and guidelines affecting drug and disease state, understanding issues to assigned responsibilities with an in depth understanding of product labeling/literature, including safety profile. Understand, implements and improves department SOPs. Clinical knowledge to apply to adverse event data collection and assessment. May serve as a representative for Safety Management on cross-functional projects, but does not assume decision-making responsibilities in the representative role; Contacts may include Clinical Safety Manager and a variety of multidisciplinary representatives (e.g. Regulatory Affairs, Quality Assurance, Compliance). Does not initiate strategic decisions, but is responsible for supporting the department, division and company's strategic direction Workload responsibilities are primarily study-related and include some safety higher level functioning (e.g. prioritizing workload, training, reconciliation of databases, safety surveillance). Troubleshoots problems. Problem solving involves identification of problems and proper escalation to manager. Starts to mentor/teach others with directions from lead mentor or team manager. Assists in mentoring staff by coaching and mentoring designated Safety staff on assigned safety activities. Bachelor's degree with related health science background is required. RN or clinical pharmacy experience strongly preferred. Candidates lacking the appropriate Bachelor's degree but with previous pharma experience may be additionally considered. Minimum 3 years clinical experience with a minimum of 1 year drug safety/pharma experience (or) 2 years clinical experience with a minimum of 3 years drug safety/pharma experience. Proficiency in Computers (Windows, Word, Excel) and in specific databases (e.g., oracle/clinical, PIMS, laboratory databases). Ability to critically evaluate medical data. Ability in accurately and medically presenting; of case data, both orally and in writing. Ability to identify, prioritize and assign tasks to others in Clinical Safety Manager's absence. Monitor problems through resolution. Analyze and interpret adverse event data as a component of clinical surveillance activity. Consistently exercise good judgment within policies and regulations. Effective communication skills in delivering study-related information . Associated topics: aseptic, biomedical, dietician, drug development, healthcare, immuno oncology, metabolism, pharmacometrics, physiologist, therapeutic

Scientist II/ Senior Scientist I, Virology - AbbVie

newabout 10 hours ago
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We are seeking a highly motivated and creative scientist with background in Virology, Immunology, and/or molecular biology to join the AbbVie Infectious Disease team in North Chicago, IL. We are looking for a Scientist / Sr. Scientist with experience in cell culture, tissue processing, flow cytometry (FACS), as well as standard molecular biology and biochemical techniques. Above all, we are looking for a highly motivated and collaborative individual with a passion for research, who enjoys working in a fast-paced and highly dynamic working environment.Key Responsibilities Includes: Perform mammalian cell culture and independently develop, run, analyze and troubleshoot in vitro assays, such as FACs & cell-based activity assays. Use developed in vitro assays to validate and characterize novel therapeutic entities. Demonstrate innovation and strong problem solving, analytical skills and be a team player. Work collaboratively with matrixed project teams and members of the group to drive innovation and deliver novel therapies for patients. Develop productive collaborations and communication with other groups across therapeutic areas. Timely documentation of experiments and activities in electronic archive systems. Engage colleagues in cross-disciplinary scientific discussion, present scientific data to the team. Basic: BS in Virology, Immunology, molecular biology, or related field with at 7 years of relevant experience or MS with 5 years of experience or a Ph.D with 0 years of experience. Extensive expertise in mammalian cell culture/transfection is required. Proficiency in a wide range of immunological laboratory techniques, in particular flow cytometric analysis (FACS). Proficiency in a wide range of molecular biology and immunology techniques (Molecular cloning, RNA isolation, c-DNA synthesis, qPCR, proliferation/cytotoxicity assays). Experienced in infectious disease research and BSL training or experience is a plus. Experienced in cell isolation and culture of primary immune cells (dendritic cells, macrophages and T cells) is a plus. Must possess the ability to design experiments and think independently. Strong communication and organization skills, especially the ability to work across multiple scientific disciplines and functions. Key Leadership Competencies: Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Learns fast, grasps the \"essence\" and can change course quickly where indicated. Raises the bar and is never satisfied with the status quo. Creates a learning environment, open to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation an manages innovation to reality. Equal Opportunity Employer Minorities/Women/Veterans/Disabled Associated topics: aseptic, histologist, industrial hygienist, injury, kinesiology, microbiological, nephrology, patient, therapeutic, transfection

Associate Scientist II / Scientist I, Drug Metabolism and Pharmacokinetics Bioanalysis - Redwood City

newabout 10 hours ago
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Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products - Imbruvica, Venclexta, and Empliciti - and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position will be based at AbbVie Biotherapeutics, AbbVie's immuno-oncology center in Redwood City, CA. The Drug Metabolism and Pharmacokinetics Bioanalysis (DMPK-BA) department is looking for an Associate Scientist II or Scientist I for Ligand Binding Assay (LBA) Development and Sample testing. Key responsibilities include: Develop independently LBA methods (PK and biomarker) to support preclinical and clinical studies. Work with automation experts to get the method automated on a Tecan platform; perform manual or automated sample testing by following validated test method; generate data summary table, and perform data QC reviews to ensure compliance with relevant guidelines and SOPs. Develop and/or evaluate commercial biomarker assays to determine fit for purpose of assay usage for biomarker measurement. Draft test method, assay validation plan, and validation summary reportAssociate Scientist II: Bachelor's Degree in biochemistry, biology, biomedical engineering, or equivalent education, with typically 3 or more years' experience or Master's Degree or equivalent education (no additional experience) Scientist I: Bachelor's Degree in biochemistry, biology, biomedical engineering or equivalent education with typically 5 years of experience, or Master's Degree or equivalent education with typically two years of experience. Experience with automating ligand binding assays (LBA) on robots (e.g. Tecan) a plus Good understanding of LBA principles and platforms such as ELISA, MSD, Luminex and high-sensitive platforms (Singulex, Simoa) and experience in assay development and validation Detail oriented with good trouble-shooting skills; ability to handle multiple tasks, to prioritize and adapt to change Very good organizational skills and excellent interpersonal and communication skills, interfacing with departments and external partners Key Leadership Competencies: Learn fast, grasp the \"essence\" and can change course quickly where indicated. Raise the bar and is never satisfied with the status quo. Build strong relationships with peers and cross functionally with partners outside of team to enable team work and higher performance. Create a learning environment, open to suggestions and experimentation for improvement. Associated topics: aseptic, bacteria, biomedical, cytometry, drug development, healthcare, kinesiology, nephrology, patient, pharmaceutical

2019 Experiential Internship (Undergraduate Level) - Discovery Research, Computational Biology/Bioin

newabout 10 hours ago
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AbbVie Biotherapeutics Inc. (ABR) is AbbVie's Center of Innovation in Oncology Research and Development, located in Redwood City, CA. The ABR Oncology site focuses on Immuno-Oncology (I-O), which is the study of the activation of the immune system to recognize and eliminate cancer cells. Join ABR for our 2019 Experiential Summer Intern Program! Gain hands-on industry experience, work with field experts, and meet other motivated, science-oriented college students like yourself Be prepared to work in a well-supported environment, with access to the cutting-edge tools, technologies and expertise Learn different aspects of the drug development business, and how it applies to making novel anti-cancer drugs The AbbVie Experiential Summer Intern Program is a paid, 12 week internship available in two sessions. Session 1 will start at the end of May (semester system) and session 2 will start in early June (quarter system). The program is focused on providing students with original pharmaceutical development projects, based on business need. You'll do meaningful work that has a real impact on our business and patients worldwide. POSITION DESCRIPTION: We are seeking a computational biology/bioinformatics intern to play an integral role in a multi-disciplinary team focused on developing new therapies for the treatment of cancer. The successful candidate will provide computational biology support to a team of highly skilled discovery scientists. This will involve formulating and answering biological questions using complex datasets and the creation and assessment of novel computational solutions. In particular, the candidate will help develop a bioinformatic pipeline to interrogate candidate drug target genes in multiple omics data sets. They will also design and implement an interactive, web-based tool to display and disseminate pipeline results to other AbbVie scientists. You will work in a well-supported environment, with access to the tools, technologies and expertise necessary for success.BASIC REQUIREMENTS: Enrolled in an undergraduate level program at an accredited university Available for the entire 12-weeks in session 1 (semester system) or session 2 (quarter system) Completed at least 1 year of undergraduate level studies prior to internship experience Strong academic performance with minimum cumulative GPA of 3.0 (4.0 Scale) Returning to university for at least 1 semester/quarter post-internship PREFERRED REQUIREMENTS: The ideal candidate will have experience in computational biology/bioinformatics, genomic/transcriptomic analysis, data and literature mining, and/or gene network/systems biology analysis. Prior experience with R, Shiny, or python is highly desirable. Familiarity with bash and git a plus. Excellent qualitative and quantitative analytical skills. Eager to learn different aspects of the drug development business, and how it applies to making novel anti-cancer drugs. Great interpersonal and communication skills. Equal Opportunity Employer Minorities/Women/Veterans/Disabled Associated topics: aseptic, bioengineering, bioinformatics, immunobioengineering, life science, microbiology, neurobiology, pathophysiology, physical, virus

Associate Scientist/ Scientist, Proteostasis Biology in Neurodegeneration

newabout 10 hours ago
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We are seeking a cell/molecular biologist, preferably with pharma/biotech background, to join the proteostasis group at the Foundational Neuroscience Center (FNC) in Cambridge, Boston . This individual, with a background in cell biology and/or neuroscience and strong technical expertise in molecular and cell biology, will be responsible for supporting early drug discovery efforts to identify and validate novel drug targets. This individual should enjoy working with novel technologies and thrive in a small biotech atmosphere with the resources of a large pharmaceutical company. This individual's responsibilities will also include assay development and validation, as well as characterization of model systems to study proteostasis biology and its contribution to neurodegenerative disease. Key Responsibilities: Contribute technical and scientific expertise to proteostasis project teams Execute on a planned experimental design - collect, analyze, interpret and present data Generate robust and complete data sets to support key Go/NoGo decisions on novel drug targets Develop expertise with novel technologies and laboratory techniques Lead and/or assist in writing and revising SOPs Work diligently and efficiently to meet deadlines in a fast-paced environment Read and apply relevant scientific literature Adhere to safety and compliance Participate and present in internal meetings Position will be hired based on level of experience. BS or MS in biology or related field with 3-5 years (BS), or 0-2 years (MS) of pharmaceutical and/or biotech industry experience Proficiency with cell culture techniques, transfection and lentiviral transduction methods Experience working with iPSC-derived neurons and/or primary rodent neurons. Proficiency with cellular analytical techniques such as immunofluorescence microscopy, high-content imaging, and flow cytometry. Skilled with basic laboratory techniques such as ELISA, western blotting, luminescence assays, FRET/fluorescence assays, and qPCR. Aptitude for basic statistics and software packages such as GraphPad PRISM Demonstrated ability to work well in a collaborative team-oriented environment Demonstrated ability to learn, understand and master new experimental techniques Strong organizational skills that enable multitasking and working within timelines Demonstrated record keeping, scientific writing skills, and strong verbal communication skills Equal Opportunity Employer Minorities/Women/Veterans/Disabled Associated topics: bio, biological engineer, biomaterials, biomedical, bioprocess, fermentation, hereditary, neuro, neuroscience, therapeutic

Associate Scientific Director, Oncology Early Development - Redwood City

newabout 10 hours ago
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Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products - Imbruvica, Venclexta, and Empliciti - and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position will be based at AbbVie Biotherapeutics, AbbVie's immuno-oncology center in Redwood City, CA. POSITION DESCRIPTION: With appropriate supervision, manages the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues. Oversees project-related education of investigators, study site personnel and Abbvie study staff. Responsibility will focus on early clinical development program activities but may extend to later stage development activities and product lifecycle management strategies for internal programsKey Responsibilities Include: Responsibility for review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, may be responsible for oversight of study enrollment and overall timelines for key deliverables. Contributes to design, analysis, interpretation and reporting of scientific content of protocols, investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents. May be asked to contribute to the development of a rigorous, cross-functionally-aligned, vetted Clinical Development plan in collaboration with matrix team members. Participates in opinion leader interactions related to the disease area(s); partners with Research, Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies. Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May be asked to contribute to regulatory responses and discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. PharmD/PhD with 4 years pharmaceutical industry experience. Oncology development experience, specifically early development, is highly preferred. Ability to provide input and direction to clinical research with appropriate supervision. Strong desire to collaborate in a cross-functional setting. Clinical of early phase clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred. Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable. Ability to interact externally and internally to support global scientific and business strategy. Must possess excellent oral and written English communication skills. At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Associated topics: ancmg, breast, cancer, hem onc, hematology, oncology, palliative, physician md, physician md do, radiation

Associate Director, Marketing - Oncology GPO

newabout 11 hours ago
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AbbVie has a strong specialty product portfolio that serves patients in the areas of Immunology, HCV, Oncology, with new specialty medications in development. A cross-therapeutic team within the Market Access organization specializes in working with channel partners to provide access, services and resources to ensure optimal patient care. The Oncology GPO Marketer will work closely with AbbVie's National GPO Account Executives and Oncology Brand Marketing colleagues to implement and enhance brand programs and contracting initiatives. The individual will foster teamwork across multiple stakeholders by collaborating with the Integrated Brand Team - informing investment decisions and making recommendations supported with financial analyses. The role will primarily support the Oncology franchise, with opportunities to support other therapeutic areas, as needs and abilities dictate. Key Job Responsibilities: Channel Planning and Implementation - effectively develops and communicates the Oncology GPO vision, strategy and tactics Contract Management - develops, executes and evaluates GPO contracts to ensure they are aligned and advance the capabilities of the brand Drive for Results - provides clear, concise communication to gain buy in from stakeholders to deliver impactful initiatives on time and on budget Cross-functional Collaboration - fosters strong working relationships with the Brand Marketing, Trade Marketing, Legal, Regulatory and Marketing Analytics teams as well as external collaboration partners Marketing Materials - identify and develop high-impact promotional materials that support patient needs and strategic brand objectives Compliance - Ensures that regulatory and legal restrictions and guidance is followed Industry Expertise - Up to date on current industry trends and anticipates future changes Department Operations - Support the P&L responsibilities for projects related to sales and promotional budgets Budget Support - Secure budget from Brand Team, effectively manage budget for programs by completing projects on time and on budget Basic: 10 years of Pharmaceutical Marketing experience, including 5 years of experience in GPO program management/marketing Experience with Market Access and contract negotiation Ability to develop and manage projects cross-functionally Knowledge of applicable regulations and standards affecting Pharmaceutical Products (e.g. CFR 210/211, cGMP) Familiarity with multiple therapeutic areas Knowledge of marketing concepts within strategic planning process and understanding of market research principles to draw valid conclusions and inform recommendations Bachelor's Degree Preferred: Knowledge of and/or relationships with Group Purchasing Organizations - specifically Oncology Experience in marketing and program management with specialty pharmacy and specialty distribution channel Advanced degree Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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Maintenance Technician III - Ops

newabout 11 hours ago
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To provide multi craft, skilled maintenance support to Abbvie Lake County Facility, Utility, Manufacturing, and R & D assets. Key Responsibilities Includes: Adhere to Abbvie's code of conduct and safety policies. Independently performs senior level maintenance work including but not limited to; machine lubrication, inspection, troubleshooting, repair, and fabrication. Works closely with Department Reliability Engineering regarding; Maintenance Program development, Root Cause Analysis (RCA), and Reliability Centered Maintenance (RCM) analysis. Considered SME (subject matter expert) in areas of expertise. Assist Management in development and delivery of technical training program. Accurately documents all maintenance activity in CMMS. Level of position is commensurate upon education and experience of the candidate. Associate degree, college certificate, or formal apprenticeship and 5 years of work experience related to any of the following: mechanical trades, electrical up to 13kv, HVAC/R, PLC / Controls, Instrumentation, welding, machining and fabrication. CMRT (Certified Maintenance and Reliability Technician) or equivalent accredited certification. Must demonstrate proficiency in multiple skilled trade disciplines as defined by the department skills matrix including Predictive Maintenance Technologies. Knowledge and ability to apply proper hand tools in an industrial setting. Knowledge and ability to use power tools (such as electric drills, drill press, saws, grinders, pneumatic and hydraulic tools) Ability to accurately use measuring tools (calipers, micrometers, dial indicators, scales). Intermediate computer skills (MS Windows). Solid written and verbal communication skills Valid driver's license required Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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2019 Experiential Internship - Medical Writing Intern

newabout 11 hours ago
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As an AbbVie Experiential Intern, you'll participate in a paid, ten to twelve-week summer program that is focused on providing students with robust projects throughout the summer. As an intern, you will be located at our corporate headquarters in north suburban Chicago, with housing and shuttle services for eligible students. Department Overview - Medical Writing and Clinical Trial Disclosure The Medical Writing area within Medical Writing & Clinical Trial Disclosure leads the planning, writing, reviewing, and approving of global clinical regulatory documents, such as clinical study reports, investigator's brochures, and periodic safety reports. The Medical Writers and Medical Writing Managers provide expertise in scientific and regulatory writing; software for writing, presenting, publishing, distributing, and storing documents and clinical trial information; quality control; document formatting; and management of the content, archiving documents, and project planning and management in accordance with clinical and regulatory timelines. The Medical Writers are organized by Therapeutic Areas with a Director to lead each area. Assignment Details Purpose: Responsible for providing regulatory document support to the clinical teams, ensuring successful preparation of high quality, submission-ready documents and effective implementation of the clinical writing process. Interfaces with external groups (e.g., PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Publishing) to ensure accurate and timely completion/delivery of information and review of regulatory submissions. Responsibilities: Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated regulatory documents (US and exUS). Develops a strong knowledge of US and international regulations, requirements and guidance associated with document preparation and submissions. Serves as the Medical Writing representative on project teams. Communicates deliverables needed, writing process, and timelines to team members. Ensures all electronic document deliverables are processed and compiled in alignment with timelines. Understands sources of information. Seeks out information to ensure complete documentation of all inputs. Converts relevant data and information into a form that meets regulatory document requirements. Interprets and explains data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables. Verifies that results are consistent with protocols. Explains data in manner consistent with the target audience and regulatory requirements. Challenges conclusions when necessary. Confirms completeness of information to be presented. Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following established divisional guidelines, templates, and SOPs. Arranges and conducts review meetings with the team. Bachelor of Science candidate with relevant writing experience, or Bachelor's candidate in English or communications, with relevant science experience; or Master's candidate in science or technical writing; or PhD candidate in science. Graduate or Undergraduate Level Student Completed at least one year of college education before beginning internship Must be enrolled in school the semester following your internship Minimum Cumulative GPA: 3.0/4.0 Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship (students on an F1 visa with CPT can be accommodated). Preferred: Willingness to learn about international regulations, requirements and guidance associated with document preparation and submissions. Willingness to learn about CTD content templates. Developing knowledge of current electronic document management systems and information technology. Excellent written and oral communication skills. Ability to assimilate and interpret scientific content and translate information for appropriate audience. Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy. Expert in Microsoft Office suite of software programs. Excellent working knowledge of software programs in Windows environment. Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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Medical Science Liaison, Immunology/Gastroenterology, North TX/OK

newabout 11 hours ago
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The Medical Science Liaison (MSL), is a field based scientific expert that strategically supports the scientific and business objectives of a designated therapeutic area across the product life cycle. MSLs are the primary communicators of AbbVie science within a specific geography with healthcare professionals. MSLs are the field scientific experts on given disease states and treatment options within a designated therapeutic area. They combine strong business acumen, clinical expertise, market awareness, and serve as a conduit of information both externally and internally to a cross functional customer base internally within AbbVie. Based on therapeutic needs and product life cycles, teams may focus on certain responsibilities to a greater or lesser degree, including clinical development and pipeline support. This is the entry level MSL position in which the individual contributor will learn the capabilities and responsibilities of the role within the AbbVie landscape. Responsibilities Include: Develops, executes and maintains high impact territory plans, including HCP and Investigator engagement plans in alignment with therapeutic area medical and scientific objectives with a focus on quality. Uses data and analytics to seek out and maximize opportunities within their territory. Identifies, gains access to, and develops professional customer centric based relationships with external experts (EEs) in therapeutic areas within assigned geography. Delivers on territory plan objectives, meets assigned project deadlines, and achieves annual functional goals. Generates and documents meaningful data point observations (DPOs). Practices core capabilities in Segmentation, DPOs, as well as Optimal Resource Utilization, including financial decisions. Responsible for compliance with applicable Corporate and Divisional Policies and Procedure, including accurate and timely documentation as it relates to HCP interactions. Scientific Resource to External HCPs and other Stakeholders Provides education relative to disease state, therapeutic landscape and AbbVie products across the product lifecycle to healthcare providers and researchers. Therapeutic Disease State, Landscape, and Asset Expert Continually educates self on market issues/trends, product knowledge, and new therapeutic areas of interest as it pertains to specific business responsibilities, including creating awareness and relationships for AbbVie in the Medical community. Supports research initiatives across development at the request of R&D to include, but not limited to, site evaluation and identification, recruitment, investigator meetings, external expert identification, and external collaboration management. Maintain Cross-functional Field Partnerships Creates, maintains, and collaborates in relationships with Cross-Functional partnerships, including, but not limited to in field teams, , engagement with site management and monitoring and clinical research associates, the Therapeutic Area, and with the Medical Outcome Science Liaisons. Works with in-field teams, as appropriate, to develop and execute Account plans designed to support and meet shared business objectives. Serves as a scientific resource to commercial partners as appropriate to support activities such as Medical Congress staffing and training initiatives Bachelor's degree in the health sciences from an accredited university required. Advanced medical degree preferred in a relevant scientific discipline. Doctorate strongly preferred in a health science or clinical discipline. Significant clinical and/or industry experience in relevant therapeutic area may be accepted in lieu of education requirements. Greater than or equal to 2 years of clinical, scientific/research, or industry related experience or equivalent preferred. The MSL must possess problem solving and analytic skills to be able to identify, and translate specific territory and corporate needs, into an action that will achieve objectives. Exhibits leadership attributes that align with company-wide initiatives such as: All for One AbbVie, Clear and Courageous, Make Possibilities Real, Agile and Accountable, and Decide Smart and Sure. Possesses foundational skills in Scientific Storytelling, Identifying Mobilizers, Medical Challenger, and Active Listening. An essential requirement of the position is to meet health care industry representative (HCIR) credentialing requirements to gain entry into facilities and organizations that in your assigned territory. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, and proof of immunization/vaccination for various diseases. Must be willing to travel up 75% of your time From Dallas area Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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Medical Science Liaison, Immunology/Gastroenterology, CO

newabout 11 hours ago
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The Medical Science Liaison (MSL), is a field based scientific expert that strategically supports the scientific and business objectives of a designated therapeutic area across the product life cycle. MSLs are the primary communicators of AbbVie science within a specific geography with healthcare professionals. MSLs are the field scientific experts on given disease states and treatment options within a designated therapeutic area. They combine strong business acumen, clinical expertise, market awareness, and serve as a conduit of information both externally and internally to a cross functional customer base internally within AbbVie. Based on therapeutic needs and product life cycles, teams may focus on certain responsibilities to a greater or lesser degree, including clinical development and pipeline support. This is the entry level MSL position in which the individual contributor will learn the capabilities and responsibilities of the role within the AbbVie landscape. Responsibilities Include: Develops, executes and maintains high impact territory plans, including HCP and Investigator engagement plans in alignment with therapeutic area medical and scientific objectives with a focus on quality. Uses data and analytics to seek out and maximize opportunities within their territory. Identifies, gains access to, and develops professional customer centric based relationships with external experts (EEs) in therapeutic areas within assigned geography. Delivers on territory plan objectives, meets assigned project deadlines, and achieves annual functional goals. Generates and documents meaningful data point observations (DPOs). Practices core capabilities in Segmentation, DPOs, as well as Optimal Resource Utilization, including financial decisions. Responsible for compliance with applicable Corporate and Divisional Policies and Procedure, including accurate and timely documentation as it relates to HCP interactions. Scientific Resource to External HCPs and other Stakeholders Provides education relative to disease state, therapeutic landscape and AbbVie products across the product lifecycle to healthcare providers and researchers. Therapeutic Disease State, Landscape, and Asset Expert Continually educates self on market issues/trends, product knowledge, and new therapeutic areas of interest as it pertains to specific business responsibilities, including creating awareness and relationships for AbbVie in the Medical community. Supports research initiatives across development at the request of R&D to include, but not limited to, site evaluation and identification, recruitment, investigator meetings, external expert identification, and external collaboration management. Maintain Cross-functional Field Partnerships Creates, maintains, and collaborates in relationships with Cross-Functional partnerships, including, but not limited to in field teams, , engagement with site management and monitoring and clinical research associates, the Therapeutic Area, and with the Medical Outcome Science Liaisons. Works with in-field teams, as appropriate, to develop and execute Account plans designed to support and meet shared business objectives. Serves as a scientific resource to commercial partners as appropriate to support activities such as Medical Congress staffing and training initiatives. Bachelor's degree in the health sciences from an accredited university required. Advanced medical degree preferred in a relevant scientific discipline. Doctorate strongly preferred in a health science or clinical discipline. Significant clinical and/or industry experience in relevant therapeutic area may be accepted in lieu of education requirements. Greater than or equal to 2 years of clinical, scientific/research, or industry related experience or equivalent preferred. The MSL must possess problem solving and analytic skills to be able to identify, and translate specific territory and corporate needs, into an action that will achieve objectives. Exhibits leadership attributes that align with company-wide initiatives such as: All for One AbbVie, Clear and Courageous, Make Possibilities Real, Agile and Accountable, and Decide Smart and Sure. Possesses foundational skills in Scientific Storytelling, Identifying Mobilizers, Medical Challenger, and Active Listening. An essential requirement of the position is to meet health care industry representative (HCIR) credentialing requirements to gain entry into facilities and organizations that in your assigned territory. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, and proof of immunization/vaccination for various diseases. Must be willing to travel up 75% of your time From Denver area Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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Director, Global Medical Affairs (GMA) Statistics

newabout 11 hours ago
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Overview: Global Medical Affairs (GMA) Statistics is responsible for providing services in the area of biostatistics and mathematics to Global Medical Affairs and other corporate divisions. These services are supplied in the context of a cooperative, product-oriented effort and included supporting all GMA studies, scientific presentations and publications for all therapeutic areas, evidence evaluations and generations based on real world evidence, and Health Technology Assessment. Key Responsibilities: Leads and directs statistical planning and strategy development for an assigned therapeutic indication area focusing on the GMA related activities in the assigned indication. Through own efforts and those of their staff provides scientific and statistical expertise for GMA study designs and conduct, scientific presentations and publications, evidence evaluations and generations based on real world evidence, and Health Technology Assessment GMA Study Protocol Development: Directs the development of scientific protocols, ensuring they are scientifically sound and the research hypotheses and corresponding study designs are aligned with the product strategy, and meet scientific and/or applicable regulatory needs. Ensures statistical methodology is appropriate and sound, consistent with the objective(s) of the scientific explorations Statistical Analyses: Demonstrates outstanding understanding of statistical concepts and methodologies. Takes a leadership role in introducing new/novel statistical methodological approaches into analysis plans which improve the efficiency and sensitivity of study results. Provides sufficient details to allow programming implementation. Ensures that all the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately Database Explorations: In collaboration with GMA, Clinical Statistics, Data Sciences, Statistical Programming and other stakeholders to assess and evaluate existing databases and real world evidence for evidence evaluation and generation to d eliver useful, customer-centric evidence and insights to drive decisions Scientific Reports and Publications: Ensures that study results and conclusions are scientifically sound, clearly presented, and supported by the statistical analyses provided. Ensure timely and quality statistical deliverables. Represents GMA Statistics on product issues at management and/or product review meetings. Provides in-depth scientific/statistical review for scientific reports and publications. Ensures the accuracy of the statistical component of scientific reports and/or publications with high quality Product Team Involvement: Partners with GMA, Clinical Research and Clinical Statistics to develop scientifically appropriate strategies for GMA studies, presentations, and publications in assigned therapeutic area(s). Represents GMA Statistics to provide functional area input for life cycle management of products. Leads communications between assigned product team(s) and functional management. Builds/drives inter-department relationships and teamwork Consultation: Partners with multiple stakeholders to develop scientifically appropriate development strategies for one or more major drug discovery or development projects Effectively plans and manages statistical resources to meet assigned project priorities Works with manager and appropriate administrative staff to arrange for and manage alternative resources (i.e., consultants, CROs, interns, temporary staff) to satisfy needs of assigned projects Interacts with relevant stakeholders to ensure that appropriate statistical methods are adequately and consistently applied in all scientific and regulatory documents, presentations, and publications Provides scientific/statistical insight in addressing questions from clients, and proposes novel solutions to technical issues Independently pursues analyses suggested by the data, including the pursuit of statistical knowledge needed to address the scientific issue In collaboration with Statistical Programming or their designee, ensures that all internal and external statistical software used in the performance of analyses defined in SAPs or scientific research plans are efficient, validated, and meet internal SOPs and external regulatory requirements Acts as the liaison for statistical issues on AbbVie collaborative studies with outside universities, government agencies, steering and/or data monitoring committees, joint ventures or licensing activities Builds external scientific contacts which foster professional development and promote the reputation of the department Demonstrates broad understanding of scientific research designs, worldwide regulatory requirements and commercial aspects of drug development Critically reviews regulatory submission documents for one or more major drug discovery or development projects Effectively and persuasively presents statistical concepts, evidence, interpretations, and logical arguments to the project team, management, regulatory agencies, and scientists Training, Supervising, Mentoring: In conjunction with other directors, and/or administrative management, coordinates and supervises statistical support for the assigned indication or development programs Effectively mentors other development stakeholders with regards to statistical methodology and departmental operations Manages personnel by appropriately delegating assignments, reviewing activities and defining and ensuring review of deliverables so that projects are completed on time with high quality Stimulates the scientific development of staff Develops and supervises departmental seminars, short courses, and the publication/presentation of scientific articles Works with other directors and/or administrative management to develop and arrange appropriate training opportunities for staff and facilitate their timely career development Works with other directors and/or administrative management to recruit qualified statisticians to the organization Ensures that staff and self are compliant with training requirements Demonstrates a high degree of responsibility in maintaining DSS / Biometrics standards, GxP compliance, and best operating practices for staff and self Basic: M.S./Ph.D. in Statistics, Biostatistics or a related field. At least 8 years (PhD) or 12 -14 years (MS) experience in pharmaceutical development and applied statistics/statistical consulting. Project lead experience required. Broad knowledge of statistical methodology and global regulatory requirements, expertise in drug discovery or development, and an understanding of commercial aspects of drug development. Advanced knowledge of statistical methodology and global regulatory requirements, expertise in drug discovery or development, and an understanding of commercial aspects of drug development Must have demonstrated exemplary statistical experience in managing and completing multiple projects or equivalent experience Experience interacting with external experts and/or regulatory agencies highly desirable Excellent communication skills, both oral and written Jointly with other project team members, develops and evaluates options for meeting project team goals under time and budgetary constraints Proposes and evaluates options for responding to questions from internal and external sources, including regulatory agencies Implements the agreed upon solution after discussion with other stakeholders Identifies opportunities for, and leads teams for process improvement initiatives Actively participates in risk assessment and development of contingency plans Productive in relevant statistical research and problem solving Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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Medical Director - Immunology

newabout 11 hours ago
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Medical Director, Immunology Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff. Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned. Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies. May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB). Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Basic Requirements Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) Immunologist or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a sub-specialty (Immunology) fellowship is desirable. At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent. Ability to run a clinical research program of moderate complexity with minimal supervision. Ability to perform and bring out the best in others on a cross-functional global team. Ability to interact externally and internally to support a global scientific and business strategy. Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols. Must possess excellent oral and written English communication skills. Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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Senior Scientist I Engineering, Drug Products

newabout 11 hours ago
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Purpose: Serve as a lead engineer on a given project for oral dosage form products . Assumes technical ownership of a given project or technical challenge in coordination with other colleagues and functional areas. Conceive and implement novel experimental approaches to answer scientific questions. Investigate, identify, develop, and optimize new methods and techniques. Contribute to project science in area of expertise. Develop productive collaborations and communications with other groups across science disciplines. Leads technical transfer and start-up of new solid dosage form processes and initiates, and designs and executes programs to optimize or improve processes. Represents function on CMC teams. May lead tech transfer teams. Provides technical support and training for the plant's manufacturing areas. Demonstrates high proficiency across a wide range of relevant technologies. Routinely demonstrate scientific initiative and creativity in development activities. May initiate new areas of investigation that are scientifically meaningful, reliable, and can be incorporated directly into a development program or current project. Highly autonomous and productive in performing experiments, requiring only minimal direction from or interaction with supervisor. A primary author of process development and technical reports, presentations, and regulatory documents. Understand and adhere to corporate standards regarding code of conduct, safety, GxP compliance, appropriate handling of materials, and potent and controlled drugs where applicable. Use statistical process control and other statistical tools for comparison and hypothesis testing. Apply engineering fundamentals to model the process to solve complex technical problems. Conducts efficient experimental design with controls and consideration of error and variation for experiments and evaluations in the lab. Direct mentorship of others Bachelor's Degree or equivalent education in an engineering field and typically 7-10 years of experience, Master's Degree or equivalent education and typically 4-7 years of experience, PhD and no experience necessary. Possess thorough theoretical and practical understanding of own scientific discipline. Experience in unit operations such as granulation, milling, compression, coating and/or extrusion processes for oral dosage forms.

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Project Coordinator/SharePoint/internal,external/COMM skills/Graphic+

newabout 23 hours ago
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This individual will maintain a broad understanding of AbbVie's capabilities and technologies in digital communications, primarily using SharePoint, as well as the latest trends in intranet ...

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Analyst, RA Regulatory Policy and Intelligence

new1 day ago
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Support analysis of regulatory trends in the environment in key areas of interest to AbbVie * Conduct sophisticated searches of regulatory intelligence sources and present findings in a summary that ...

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Area Business Executive- California

13 days ago
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To serve as executive liaison between AbbVie and key national/regional accounts and organizations. Manage field deployed specialists calling on pediatric endocrinology offices and in the acute care ...

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Clinical Research Coordinator

13 days ago
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...¬†GCP, AbbVie SOPs and functional area processes. ‚ÄĘ For assigned countries, may lead and execute study start-up activities including but not limited to: - Prepare submissions to central Ethics¬†...

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Quality Assurance Specialist

19 days ago
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Interface with Third Party Manufacturers, health care professionals, general public, internal customers, AbbVie functional areas and regulatory agencies. Qualifications: * Knowledge of global ...

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Senior Director, Epidemiology

about 1 month ago
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In addition to leading studies, programs and initiatives, he or she develops strategic external relationships and represents AbbVie at congresses, meetings and other professional events. Some key ...

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Research Associate/Sr. Research Associate in Protein Biochemistry

about 2 months ago
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Under the terms of the agreement, AbbVie paid Morphic an upfront payment of $100 million for exclusive license options on product candidates directed at multiple targets. Morphic retains co ...

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