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448 💼 Alkermes Jobs / Employment in Waltham, MA

Associate Director, Med Info

new1 day ago
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Position: Associate Director, Medical Information Company: Alkermes, Inc. Location: Waltham, MA Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more inform

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Senior Systematic Reviewer (Research Associate III) Meta Research ( Waltham MA or London UK)

new3 days ago
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Senior Systematic Reviewer (Research Associate III) - Meta Research ( Waltham MA or London UK)**We are looking to fill this role in our Waltham , MA or

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Director of Client Services

new4 days ago
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Alkermes is seeking a Director of Client Services to drive the business as a key leader responsible for designing and implementing strategy at a global scale using next-generation platforms that creates both a seamless employee experience and further accelerates the company’s internal and external growth efforts. This leader will be responsible for global end-user computing, client applications, device management, collaboration experiences, logistics, global service desk, conferencing, conference rooms and mobility among others across the Alkermes enterprise. This leader will develop a team and culture focused on setting (and meeting) high expectations, responsive service level agreements, and achieving metrics that deliver best-in-class client and collaboration services on a consistent basis. In providing global leadership for the development and implementation of integrated company-wide solutions, the person will own the creation of the end-user technology vision and strategy aligned with both the corporate and IT vision and strategies. This Director will be responsible for analyzing technology trends, assessing the impact of emerging technologies/platforms on the environment, and leverage data to drive world-class strategies and solutions. Other key deliverables will be based on service strategy, design, transition, operation, and continuous improvement of the end user compute and collaboration platforms. This position will require occasional travel. JOB RESPONSIBILITIES Technology and group oversight Develop, manage, measure and report on key service-level metrics, KPIs, including average response time, first-contact-resolution rate, mean time to repair, call avoidance, demand mix and end-user productivity. Engage, collaborate and communicate with user groups to maintain alignment with support and new application deployment initiatives. Advance the disciplined use of a knowledge repository to share information among all levels of IT service and support. Oversee the management of key license renewals originating within Client Services. Engage and direct RFP processes with vendors for software licensing, enterprise computer purchases, service enhancements and service changes. Manage escalation for urgent and complex end user support issues. Budget Management & Optimization Responsible for the budget of the global Client Services organization, with a focus on: Establishing budget(s). Managing costs. Establishing productivity targets. Managing to targets. Strategic Planning Provide strategic and tactical direction. Plan lifecycle of personal computers, mobile devices, and account management. Translate industry and Alkermes direction to optimally position the organization. Keep abreast of advance and changes in the field and when appropriate, adopt innovations that lead to improvement and increased efficiency of Alkermes’ operations. Plan jointly with other IT leaders and business stakeholders to deliver business-enabling technologies. Standards Management Establish, maintain, and enforce standards within Client Services for personal computers and mobile devices. Establish, maintain, and measure key metrics and performance indicators and service levels. Manage key service providers to agreed service levels and performance on delivered services. Meet or exceed SLAs. Adapt standards anticipating and responding to changes in business landscape to support appropriate levels of growth and scale. Ensure IT services and processes (including those with external service providers) are conducted in line with corporate, environmental, technical, and security policies and applicable standards, legislation, and regulations (e.g. FDA, GxP, Sarbanes-Oxley, GDPR, HIPAA). Resource Management Provide leadership, direction and oversight to local and global IT Client Services teams (including staffing, budgeting, and other related management and administrative functions) Establish a high-performing global management team for Client Services Coach, develop and mentor team members within and outside their organization. Prioritize and align internal and external resources. Manage key vendors and contracts for IT Client Services in conjunction with other internal and external stakeholders (e.g. Strategic Sourcing, Procurement, Legal). REQUIRED KNOWLEDGE AND EXPERIENCE: Bachelor’s Degree, or equivalent experience. Minimum of 10 years work experience in managing helpdesk, field, desktop and technology support preferably in Life Sciences or Manufacturing within a regulated environment. Proactive, outgoing approach towards introducing ideas and participating in detailed technological discussions. Ability to work and manage successfully as a leader within a global, virtual team across multiple time zones. Experience with ITSM tools (ServiceNow). Strong customer service, coordination, interpersonal and conflict management skills. Demonstrated history of leading team(s) to successful outcomes. Proficient in Microsoft Office products, collaboration tools such as WebEx, and conference room technologies. Excellent verbal and written communication skills. Effective risk analysis and stakeholder facilitation to reach timely decisions. Ability to adapt and remain effective in a fast-paced and dynamic environment. The role will be based in Waltham, MA.

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Director of Infrastructure Delivery

new4 days ago
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Alkermes has an exciting opportunity for a Director of Infrastructure Delivery, responsible for the overall operations of its global technology infrastructure. The Director of Infrastructure Delivery is the leader of the Infrastructure and technology operational portfolio reporting to the Senior Director, Infrastructure and Operations, and is a key member of the senior management team of the Information Services Department (which consists of the senior application and security leaders). The Director of Infrastructure Delivery has operational responsibility for managing the global technology infrastructure at Alkermes (all sites) which includes the data centers, the entire wired and wireless network, systems, storage and other technology areas (backend systems support, infrastructure application support and security compliance). Additionally, the role provides oversight and coordination for critical external IT infrastructure and solutions within Alkermes (e.g. hosted, cloud, vendor-provided, and Software-as-a-Service). The Director with have overall responsibility for the creation of Operating Models to ensure the effective and efficient use of Infrastructure technology at Alkermes aligned with both the Corporate and IT vision and strategies. This includes both on- and off-premises (cloud) environments and the appropriate management of related components. This role is responsible also for Budget Management & Optimization, Resource Management, Strategic Planning. Job Responsibilities Operational Oversight Direct the day-to-day operational responsibilities for the data centers, network management, storage, and systems. Direct infrastructure planning and maintenance. Monitor performance of the technology infrastructure, review and remediate its failures. Verify technology standards and best practices are maintained across the organization. Verify technical problems are resolved in a timely and cost-effective manner. Manage outsourced partners and vendors for contract compliance. Manage escalation and virtual team coordination/troubleshooting for urgent and complex service outages and issues. Ensure response to changing business needs when appropriate balancing risk, cost, and user experience. Budget Management & Optimization Responsible for the budget of the LAN management and system/device management, data centers, network, storage, systems, and telecom with a focus on: Establishing budget(s). Managing costs. Establishing productivity targets. Managing to targets. Resource Management Provide leadership, direction and oversight to internal (local and global) and external partner Infrastructure Delivery teams (including staffing, budgeting, and other related management and administrative functions) Coach, develop and mentor team members within and outside their organization. Recruit and develop staff. Prioritize and align internal and external resources. Manage key vendors and contracts for Infrastructure Delivery in conjunction with other internal and external stakeholders (e.g. Strategic Sourcing, Procurement, Legal). Strategic Planning Provide strategic and tactical direction. Plan lifecycle of data centers, network, systems, storage and backend devices. Translate industry and Alkermes direction to optimally position the organization. Keep abreast of advance and changes in the field and when appropriate, adopt innovations that lead to improvement and increased efficiency of Alkermes’ operations. Plan jointly with other IT leaders and business stakeholders to deliver the technology infrastructure (including Architecture, Operations, Security, Client Services, and Business Applications). Standards Management Establish, maintain, and enforce standards within the Infrastructure Delivery groups with a focus on network management, data centers, storage, and systems. Establish, maintain, and measure key metrics and performance indicators and service levels. Manage key service providers to agreed service levels and performance on delivered services. Meet or exceed SLAs. Adapt standards anticipating and responding to changes in business landscape to support appropriate levels of growth and scale. Ensure IT services and processes (including those with external service providers) are conducted in line with corporate, environmental, technical, and security policies and applicable standards, legislation, and regulations (e.g. FDA, GxP, Sarbanes-Oxley, GDPR, HIPAA). Required Education and Experience Bachelor’s degree in the field of computer science or another rigorous discipline or equivalent industry experience. 10-15 years of technology experience, preferably in Life Sciences or Manufacturing within a regulated environment. Ability to work and manage successfully as a leader within a global, virtual team across multiple time zones. Experience with ITSM tools (ServiceNow). Experience with Cisco-based networks, HP compute platforms, and EMC storage. Experience with cloud-based infrastructures, specifically Amazon Web Services and Microsoft Azure. Strong customer service, coordination, interpersonal and conflict management skills. Demonstrated history of leading team(s) to successful outcomes. Proficient in Microsoft Office products, including PowerPoint, Excel, Word, and Outlook. Excellent verbal and written communication skills. Effective risk analysis and stakeholder facilitation to reach timely decisions. Ability to adapt and remain effective in a fast-paced and dynamic environment. The role will be based in Waltham, MA.

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Director, HEOR

new4 days ago
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Alkermes, Inc is seeking a Director to join the Health Economics & Outcomes Research (HEOR) team (located in Waltham, MA) to develop and execute strategic plans to support the value proposition of Alkermes products through each stage of the lifecycle. He/she will develop and implement (US) economics and outcomes strategy for one or more products within a therapeutic area. This is a strategic as well as a technical position with project-specific responsibilities. The Director will collaborate with colleagues in other functional areas including those in Clinical Development, Medical Affairs, Government Policy, Regulatory, Brand and Payer Marketing, and National Account Teams. This person must have a successful track record of developing HEOR strategies and executing project plans for products in development through post-launch. This position reports to the Senior Director / Head of HEOR. Key Responsibilities: Support the development of clinical, economic, and patient-centered value propositions related to Alkermes’ products Lead the development of HEOR strategy and supporting tactics for Alkermes’ products.Studies may include, but are not limited to: o Retrospective database analyses o Cost-effectiveness and budget impact models o Indirect treatment comparisons and systematic reviews o Non-interventional real-world effectiveness studies o Clinical outcomes assessment (COA) measure development and validation Effectively lead external research partners to ensure projects are scientifically rigorous, medically relevant and address business needs as well as the needs of patients, health care providers and payers. Support the development of the AMCP and other value dossiers, peer-review publications as well as tools that support formulary decision making and treatment of appropriate populations Collaborate with home office and field-based internal experts in the development and execution of field-based, customer-focused initiatives (e.g., models, dossiers, scientific communications, slide kits, formulary/regulatory dossiers) Train and support internal colleagues (e.g., medical and payer field teams) on HEOR methodologies and data results Provide technical oversight and guidance to research support staff; serve as an internal resource for research design, HEOR methodologies, analytic techniques and reporting of health economic and outcomes research Ensure that Alkermes’ clinical development programs contain outcomes measures that are appropriate and meaningful to patients, health care providers and payers Maintain close working relationships with cross functional colleagues within Medical Affairs, Clinical Development, Regulatory, Marketing, field teams) to support and enhance clinical development programs and access to our products Identify and maintain successful research relationships with HEOR key opinion leaders and other clinical/academic consultants Represent the Alkermes Medical Affairs department for HEOR-related activities at external professional, scientific meetings and forums Desired skills and experience: Advanced degree (PhD, MD, MPH, or PharmD) in a scientific discipline. A clinical background should be supplemented with advanced quantitative training demonstrated by an MPH or MS in a relevant field. Minimum of 7 years of experience in health economics, and outcomes research; with at least 3 years within a pharmaceutical or biotech company In-depth knowledge of the healthcare industry including the pharmaceutical industry (R&D, clinical research and commercialization) as well as the managed care marketplace, hospital systems, and integrated systems of care Competency in medical science, epidemiology, clinical trials, drug development, outcomes research, and pharmacoeconomics including a deep understanding of research methods, health economics, and related disciplines Demonstrated capabilities to develop HEOR strategic plans and manage multiple studies simultaneously; excellent project management to ensure studies delivered on time and within budget Excellent process and project management skills including the ability to manage a significant volume of projects with exercise of good triage and judgment skills Track record of publications in peer-reviewed journals demonstrating experience in COAs, observational research, and/or health economics Results oriented and excellent analytic and collaboration skills combined with robust project management capabilities Proven record of outstanding written and verbal communication and negotiation skills, with experience interacting with and presenting to key customers Ability to manage complexity and ambiguity in a highly matrixed work environment; demonstrated business acumen Highly motivated self-starter who is able to work independently, deal with complex issues, develop creative solutions to complex problems, and relate to multiple internal and external stakeholders Neuroscience/CNS therapeutic experience preferred

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Associate Director/Director – Biologics Downstream Process Development

new4 days ago
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This position is responsible for leading the Biologics Downstream Process Development Team in taking Alkermes’ biologics candidates from discovery through process development, scale-up, optimization, process characterization, tech transfer, clinical production, validation and commercial launch. The Team will also work with external development and manufacturing organizations. The Biologics Process Development labs will be located in Waltham, MA with scale-up capabilities up to 200 L scale. This position will lead a group responsible for: Downstream process development, scale up, and optimization Process Characterization and Control Strategy Development Tech transfer to CMO/CDMOs Support validation and commercial launch Technical support to CMOs for deviations and investigations Qualification of new vendors and CMO/CDMOs Authoring and reviewing technical reports and relevant regulatory submissions Supporting the Regulatory group in responding to agency questions In-depth knowledge in GMP systems, sterile processing, and US/EU requirements Manufacturing tox and clinical supplies Working closely with Biologics Discovery, CMC teams, and Technical Operations to ensure product success Education / Experience Qualified candidates should have a PhD in Engineering with 15 years technical and management experience in biopharmaceutical based process development and GMP manufacturing with an established track record of successfully developing and commercializing biologic products and processes. Skills / Attributes Needed Leadership & Management Strong leadership qualities (integrity, honesty, empathy, confidence, inspiration, commitment, passion, good communicator, decisive, accountable, delegates, empowers, creative/innovative) A collaborative, passionate, empathic personality with excellent interpersonal skills that positively influences the group culture and team dynamics Active participation in team environments and freely offers constructive opinions and suggestions with the expectation they will support their teammates to assure project success Ability to lead and influence technical teams and mentor less experienced scientists and engineers Foster a culture of continuous improvement and operation excellence Detailed understanding of science and engineering principles along with up to date knowledge ofupstream biologics processing technology and regulatory expectations Experience with developing process for novel modalities and non-antibody recombinant protein products expressed in mammalian cell culture Experience in downstream biologics process development, scale-up and optimization along with a strong understanding of analytical technologies that can help enhance process understanding Demonstrated expertise and understanding of downstream unit operations such as chromatography, UF/DF, Depth Filtration, Centrifugation, Nanofiltration and viral clearance steps Experience with pilot scale operations and large scale equipment Energized solving technical problems, learning, creative thinking, and critical analysis and is committed to taking action and getting results Demonstrated knowledge and experience in designing experiments (DOE) and establishing operating ranges as well as establishing control strategies Excellent verbal, writing, and presentation skills with the ability to present concepts and results in a convincing, confident manor and to adjust presentation depth to meet needs of the intended audience

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Associate Director/Director – Biologics Upstream Process Development

new4 days ago
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This position is responsible for leading the Biologics Upstream Process Development Team in taking Alkermes’ biologics candidates from discovery through process development, scale-up, optimization, process characterization, tech transfer, clinical production, validation and commercial launch. The Team will also work with external development and manufacturing organizations. The Biologics Process Development labs will be located in Waltham, MA with scale-up capabilities up to 200 L scale. This position will lead a group responsible for: Support clone selection and cell banking Media and feed development and optimization Upstream process development, scale up, and optimization Process Characterization and Control Strategy Development Tech transfer to CMO/CDMOs Support validation and commercial launch Technical support to CMOs for deviations and investigations Qualification of new vendors and CMO/CDMOs Authoring and reviewing technical reports and relevant regulatory submissions Supporting the Regulatory group in responding to agency questions In-depth knowledge in GMP systems, sterile processing, and US/EU requirements Manufacturing tox and clinical supplies Working closely with Biologics Discovery, CMC teams, and Technical Operations to ensure product success Education / Experience Qualified candidates should have a PhD in Engineering with 15 years technical and management experience in biopharmaceutical based process development and GMP manufacturing with an established track record of successfully developing and commercializing biologic products and processes. Skills / Attributes Needed Leadership & Management Strong leadership qualities (integrity, honesty, empathy, confidence, inspiration, commitment, passion, good communicator, decisive, accountable, delegates, empowers, creative/innovative) A collaborative, passionate, empathic personality with excellent interpersonal skills that positively influences the group culture and team dynamics Active participation in team environments and freely offers constructive opinions and suggestions with the expectation they will support their teammates to assure project success Ability to lead and influence technical teams and mentor less experienced scientists and engineers Foster a culture of continuous improvement and operation excellence Detailed understanding of science and engineering principles along with up to date knowledge ofupstream biologics processing technology and regulatory expectations Experience with developing process for novel modalities and non-antibody recombinant protein products in mammalian cell culture Experience in upstream biologics process development, scale-up and optimization along with a broad understanding of analytical technologies that can help enhance process understanding Energized solving technical problems, learning, creative thinking, and critical analysis and is committed to taking action and getting results Demonstrated knowledge and experience in designing experiments (DOE) and establishing operating ranges as well as establishing control strategies Excellent verbal, writing, and presentation skills with the ability to present concepts and results in a convincing, confident manor and to adjust presentation depth to meet needs of the intended audience

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Medical Director/Senior Medical Director, Oncology

new4 days ago
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The Clinical Development group at Alkermes is located in Waltham, MA. Functions include Clinical Science, Clinical Research Scientists, Translational Medicine & Clinical Pharmacology, DMPK & BA and Medical Writing. Drug Safety and Pharmacovigilance, Statistics, and Clinical Operations are also located in Waltham. The group is tasked with designing and conducting clinical trials (Phases I-IV; domestic and international) aligned with corporate strategy, and analyzing and communicating study results. The Clinical Development Group collaborates closely and maintains excellent working relationships with various internal groups, including Preclinical Science, Regulatory Affairs, Business Development, and New Product Planning. Clinical programs are developed in conjunction with input from external subject matter experts and consultants, and are executed through partnerships with clinical research organizations. Clinical Development is composed of a “hands-on” group of dedicated professionals. Team members work flexibly and collaboratively together in a matrix environment, with a high degree of personal accountability for the success of novel and aggressive clinical programs and timelines. Position Summary This physician’s primary responsibility will be to advance the company’s immune-oncology program. In addition, this physician will help advance early stage compounds into the clinic. Key responsibilities for the Medical Director/Senior Medical Director include: Accountability for the strategic planning and execution (including study design, method selection, etc) of Phase I through IV global clinical trials Analyze and interpret data expertly, and clearly communicate results both internally and externally. Oversee ongoing medical monitoring of clinical trials. Contributing to, reviewing, and approving clinical regulatory documents (clinical study reports, regulatory submission sections, investigator’s brochures, etc.) Working collaboratively with Medical Directors, Biostatistics and Medical Writing, Drug Safety, Clinical Operations, Translational Medicine, and Regulatory Affairs. Working with US and EU regulators. Mentoring junior team members, and providing guidance and opportunity for their professional development. Minimum Education & Experience Requirements: MD with expertise in Oncology A minimum of three years’ experience working in biopharma clinical development A total of at least six years working in clinical research or clinical development, either in biopharma or academia. Direct experience interacting with regulatory authorities. Experience across all phases of clinical trials is preferred. Knowledge/Skills Needed: Excellent verbal and written communication skills, a strong scientific background with industry drug development experience, and strong team leadership skills are required. Ability to work in a team environment with both internal and external (CRO) members. Experience in Clinical trial design, especially phase 1 and proof of concept studies. Familiarity with biostatistical principles used in the analysis and interpretation of clinical trial data Familiarity with thought leaders. Domestic and international travel (up to approximately 25%) is required.

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Director of Artwork and Package Design

new4 days ago
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The Director of Artwork and Package Design is a strategic leader who is driven to deliver meaningful design solutions for Alkermes’ proprietary product portfolio. This position is responsible for leading the artwork/labeling design activities as well as delivering best practice packaging concepts to the business. This work requires a creative, conceptual, and strategic thinker who is experienced and confident in leading a talented team that manages labeling and package design, and support documentation for both commercial and clinical products within a pharmaceutical environment. The ideal candidate takes initiative and has the ability to influence and manage multiple projects, while delivering a high level of creative standards. This role has responsibility for identifying projects and driving the development of timelines with design team members and cross-functional partners. This individual will manage the security efforts for anti-counterfeiting measures, support clinical packaging & labeling and champion labeling through the review and approval process as well as implementation. The Director of Artwork and Package Design will interact cross-functionally with members of Regulatory Affairs, Commercial, Medical Affairs, Quality and others to develop, review, implement and provide systems support of GMP labeling and will integrate complex programs working within a cross functional partnership. This position requires a motivated team player who can align with and support the Alkermes business principles, mission, objectives, and goals. Essential Areas of Responsibility: Lead and partner in the process for creation, approval, and implementation of commercial and clinical printed labeling and components in collaboration with various functions Provide tactical and strategic guidance or recommendations to product labeling teams regarding placement and regulatory requirements for global packaging component labeling content and design Developing and directing branding initiatives in alignment with corporate goals Developing consistent and effective design standards that establish a "design face" for the company Lead the development and maintenance of work practices, templates, and associated documents relating to the artwork, labeling and package design function Own the phrase library and assist in the language translation process Manage internal documentation requirements including change controls, specifications, item code creations, pertinent SOPs and artwork libraries.Support document management, change control and other process requirements Process and prepare Printed Labeling required for submission Establish creative and production processes for packaging artwork execution Manage technical requirements of labeling to ensure it meets the technical standards/specifications for GS1, the contract manufacturer organizations (CMO)’s, printer, etc. Prepare and manage annual budgets Coordinate and manage the change control process for all GMP labeling and package design modifications. Employ measures for counterfeit protection to implement overt and covert anti-counterfeiting technologies. Partners with marketing, consumer research and CMC teams to develop package designs that inspire consumers and provide product protection Support qualification and/or validation of systems or equipment necessary for graphics or labeling Coordinate review, obtain internal approvals and ensure labeling follows Quality system requirements, GMP and applicable domestic, international regulatory requirements and anti-counterfeiting provisions Oversee generation of final proof copy/transparency proof and creation of commercial print-ready artwork files Serve as the primary information base for all issues related to commercial product labeling/printed components Support Regulatory Affairs in packaging responses to Health Authorities Ensure tracking of all versions, specifications and coding for each labeling component for all GMP labeling Accountable for Labeling Design process and metric tracking Act as a change leader to drive the continued development and transformation of artwork and package design systems and related strategy to meet the needs of the growing business Identify continuous improvement and best practice projects, prepare and execute project plans to deliver identified improvements related to service, cost and effectiveness Build and lead a team of professionals through succession planning, employee selection, coaching and development, and performance management activities Maintain/enhance job knowledge and understanding of industry trends by participating in educational opportunities or conferences; use of professional publications; alignment with professional organizations, maintaining personal networks. Enhance department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value and enhance customer satisfaction Represent the organisation externally as required to deliver the responsibilities of the role Competencies: The candidate will be a leader, with broad awareness of best practices in artwork design and management as well as packaging design. Self-directed with an ability to network Propensity for building, mentoring, developing, leading and managing teams with enthusiastic and effective personnel management skills Excellent interpersonal and collaboration skills including the ability to make connections, build relationships and influence at all levels Analytical and problem solving skills with record of innovation and results Strong business acumen and the ability to understand current technology trends and their impact on business strategy Extensive stakeholder management experience Capability to provide a strategic vision for the Artwork Management and Packaging Design function Demonstrates flexibility adapting to external environmental influences through development of new strategies and tactics Ability to identify processes needing improvement, coordinate change and implement effectively through leadership skills A holistic thinker who can look enterprise-wide to integrate and streamline systems Ability to make decisions at the project team level and properly escalate those decisions that cannot be resolved Ability to work with cross functional teams and multiple projects simultaneously Excellent communication & listening skills, speaks clearly and persuasively in positive or negative situations Responds well to questions, demonstrates presentation skills, participates in meetings Keen attention to detail and accuracy Maintains a high level of package design related knowledge, including current trends, methods and processes Continues professional development by stretching understanding of design, execution processes, industry best practices and related information Education & Experience Requirements: Bachelor’s degree in Graphic Design, Packaging Engineering or related field 12 years of experience in artwork design, packaging development or closely related Minimum 5 years in life sciences industry experience; experience in Pharmaceutical/Biotech an advantage A minimum of 6 years’ experience in people management/leadership roles Experience in leading and managing design leaders, cross-functional teams, supplier relationships, and deep experience training teams on how to effectively harness the power of design thinking and design excellence across the organization Established track record with evidence of excellent people management experience, project management, problem solving, collaboration, leadership and communication skills Specific Functional Software expertise (e.g. Abode Design Suite, Acrobat plus QuarkXpress; Project Management Software; Agile; or others; etc.) Experience working within a regulated industry with quality management system requirements is essential including general knowledge of GMP and CFR’s Excellent knowledge of labeling regulations and guidances Proven track record of delivering business and operational benefit in a global complex/decentralized environment Positive attitude and strong interpersonal skills required to effectively address problems and interface with other functional areas of the company. Strong understanding of budget development and spend management Physical Demands and Work Environment: Travel domestic and international – up to 20% In-house position based in Waltham, MA

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Class A CDL Drivers: Be Your Own Boss with Lease Purchasing! ( Waltham , MA )

new4 days ago
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…EVERY NIGHT! BECOMING YOUR OWN BOSS HAS NEVER BEEN EASIER. The RoadOne Lease Purchase Program puts CDL Class A Truck Drivers behind the wheel of your very own driving

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Senior Systematic Reviewer (Research Associate III) Meta Research ( Waltham MA or London UK)

new4 days ago
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Senior Systematic Reviewer (Research Associate III) - Meta Research ( Waltham MA or London UK)* * We are looking to fill this role in our Waltham , MA or

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Waltham RN/LPN

new4 days ago
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…RNs and LPNs! For patient opportunities North and West of Boston, MA including: Amesbury, Waltham , Concord, Cambridge, Lexington, Newton, Billerica, Burlington,

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Associate Director/Director - Biologics Downstream Process Development

5 days ago
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... taking Alkermes' biologics candidates from discovery through process development, scale-up ... The Biologics Process Development labs will be located in Waltham, MA with scale-up capabilities up ...

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Experienced CDL-A Truck Drivers ( Waltham , MA )

6 days ago
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…CALL NOW TO SPEAK WITH A RECRUITER: (866) - EXCELLENT BENEFITS: Medical /Dental/Vision/Prescription Drug plans 401k Paid Vacation High Tech Equipment Paid Weekly

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Director of Infrastructure Delivery

12 days ago
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Director of Infrastructure Delivery Job ID 9508 Location Waltham, MA Field Locations Company Overview Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wi

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Senior Global Recruiter Human Resources ( Waltham , MA or Bethesda, MD)

13 days ago
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Senior Global Recruiter - Human Resources ( Waltham , MA or Bethesda, MD)Position Overview:Reporting to the Executive Director of Global Recruitment, serves as a

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Senior Global Recruiter Human Resources ( Waltham , MA or Bethesda, MD) - Evidera

13 days ago
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Senior Global Recruiter - Human Resources ( Waltham , MA or Bethesda, MD) Position Overview: Reporting to the Executive Director of Global Recruitment, serves as a

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Lead Validation Engineer

16 days ago
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Lead Validation Engineer Job ID 9478 Location Waltham, MA Field Locations Massachusetts Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

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Manager, Patient Access Services

19 days ago
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Manager, Patient Access Services Job ID 9543 Location Waltham, MA Field Locations Company Overview Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilm

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Senior Director IT, Enterprise Applications

about 1 month ago
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Senior Director IT, Enterprise Applications Job ID 9405 Location Waltham, MA Field Locations Company Overview Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facil

jobs byAdzuna

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