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+1k đź’Ľ Vertex Pharmaceuticals Jobs / Employment in Boston, MA

Senior Manager, Technical Operations (Drug Substance Manufacturing) at Vertex - Boston

newabout 1 hour ago
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Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com. Vertex is seeking a talented individual to join our Technical Operations group in Boston, MA as a Senior Manager. Our group of highly productive, results-oriented individuals, the Vertex Technical Operations team is responsible for building and operating the global supply network that delivers our commercial active pharmaceutical ingredient (API) and drug product (DP) to ensure uninterrupted treatment to patients. An exceptional chemical, analytical and engineering technical aptitude, as well as managerial excellence is required for successful execution of our responsibilities.The Senior Manager is an emerging leader and key technical contributor, who represents Technical Operations in cross-functional working teams with responsibilities for managing drug substance manufacturing operations under cGMP with our external third party contract manufacturing organization (CMOs) partners. They are responsible for successful collaboration within Vertex to aid process development to be suitable for commercial validation under a Quality by Design (QbD) paradigm at our CMOs. The candidate will be a subject matter expert in process CMC and cGMP principles, with proven experience in large scale drug substance production under cGMP in a plant environment. They will require a strong knowledge of small molecule development, chemical engineering and plant unit operations related scale-up manufacturing. The Senior Manager takes full responsibility within scope of the position to work with various stakeholders (such as Quality, Supply Chain, Regulatory, Development, suppliers, etc.) to proactively and collaboratively resolves issues that may negatively impact project timelines or deliverables.Key Responsibilities:Recognized as a subject matter expert and acts as a resource in one or more technical areasRepresents Tech Ops on cross-functional CMC sub teams, with minimal guidance, to influence late stage process/product development and minimize subsequent commercialization riskActs as day-to-day point of contact with contract manufacturing partners; represents Technical Operations on working teamsMay lead technical transfer and process validation activitiesIndependently generates and reviews technical documentation such as process validationprotocols / reports and NDA source documents; Leads resolution of quality investigationsUtilizes trend analysis to mitigate process risk and identify improvement opportunitiesLeads material qualification activitiesMentors junior Technical Operations staff and may direct activities of other staff membersWorks with supervisor to develop tools and standards for department functionsEnsures positive and effective relationships between Vertex and key suppliers of materials, technology, and manufacturing resourcesPartners with Supply Chain on activities to enable new material suppliers and manufacturing sitesWorks with CMOs, Quality and Regulatory on activities related to the identification and execution of complex continuous process improvement projects, technical investigations, and routine trending of manufacturing data within a Quality by Design (QbD) frameworkMinimum Requirements:PhD (chemistry/chemical engineering) with 4 years of direct work experienceMS (chemistry/chemical engineering) with 5 years of direct work experienceBS (chemistry/chemical engineering) with 7 years of direct work experienceExperience in scale-up/late phase clinical development and technical support in manufacturing environments, including authoring manufacturing and Quality technical documentationDemonstrate expert knowledge and understanding of the principles and practice of cGMPs and associated regulatory considerations in a commercial pharmaceutical environmentStrong knowledge of lean/six sigma, statistics, and/or DOEAbility to travel up to approximately 20% Preferred Qualifications:Experience with Quality by Design (QbD) and Process Analytical Technology (PAT) initiativesExperience in managing external scientific activities and relationships with CMOsPast group leadership and supervisory experienceVertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected] Associated topics: clean room, coiler, ear piercing, medical technologist, operational staff, pharmacy technician, tech, technician, technician lab, technician staff

Quality Specialist

newabout 1 hour ago
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Boston, MA Full-Time : Full-Time Job Description: This position will be responsible for supporting the vendor management program for Vertex Audit and Inspection Management, working closely with the operational functions and other QA groups to define the processes and systems to be audited. This role will support and maintain the vendor and internal audit schedules, ensuring that audits are conducted, CAPAs are completed and metrics are evaluated and presented to management. Experience in vendor audits procedures would be required. KEY RESPONSIBILITIES: Support GMP, GCP and GLP vendor management and auditing process; Plan, scope, and schedule the audit with vendors; Consults with

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Territory Sales Manager

newabout 10 hours ago
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…a positive and supportive manner at all times. This position is located in Boston , MARequired Skills Knowledge of medical device manufacturing is a plus. Ability

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PMHNP Boston , MA Outpatient Full time Great pay and Benefits - Northeast Healthcare Recruitment

new1 day ago
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…Inclusive Care for the Elderly) and located in the Mattapan area of Boston . Top Pay plus a great benefits package. Minimum Skills,Experience and Education: Masters

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Bus Driver - Boston MA Up To $10,000 Sign On Bonus!

new1 day ago
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…and you earn money while you learn. Greyhound Driver Benefits - Offering major medical plans, dental, vision, free travel, 401K with company match and more. To

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Temporary Clinical Supply Chain Coordinator

new2 days ago
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: Temporary Contract, 6 Months Vertex Pharmaceuticals Incorporated is looking to hire a Clinical Supply Chain Coordinator to join the Clinical Supply Chain Management team in Boston, MA. The Clinical ...

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Associate Director/Director, Program and Portfolio Management

new2 days ago
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Boston, MA Full-Time : Full-Time Job Description: The Associate Director/Director role is within the Program and Portfolio Management group at Vertex and functions as a Global Program Manager for clinical stage programs in pain or other Vertex disease areas. This position will organize and facilitate project teams for clinical assets from early clinical development through lifecycle management. This person will enable a high performing cross-functional team to develop global, integrated development plans and program level strategies, ensure alignment with portfolio plans through senior management, and drive the execution of development plans. The individual is expected to ensure comp

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Sr. Strategic Sourcing Manager, IT

new2 days ago
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Boston, MA Full-Time : Full-Time Job Description: Primary activities for this position include category management for IT spend, RFx development, competitive bid analysis, contract development and negotiations, and strategic supplier on-going management. Additional focus on optimization of internal sourcing processes, work flows and interfaces in effort to reduce time of delivery and costs in support corporate objectives and industry best practices. Success driven by building strong relationships with internal business partners while developing and implementing procurement strategies to meet the business needs. This individual will be expected to be result focused and deliver value a

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Senior Director, Global Medical Information

new2 days ago
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Boston, MA Full-Time : Full-Time Job Description: The Senior Director, Global Medical Information will function as the Head of Global Medical Information and set the strategic vision of the Global Medical Information Department at Vertex. He/she will oversee a team of individuals responsible for the providing Medical Information Services Globally, providing Industry leading technology and innovative solutions for Medical Information and Medical Review operations. The position will report to the Vice President, Global Medical Communications and Operations within the Global Medical Affairs team. GENERAL RESPONSIBILITIES AND REQUIRED SKILLS This position will lead a team that coordinates

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Medical Director, Non CF Pipeline, North America Medical Affairs

4 days ago
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Boston, MA Full-Time : Full-Time Job Description: Reporting to the Vice President of North America Medical Affairs (NAMA), the Medical Director Non CF Pipeline is part of the NAMA organization at Vertex headquarters in Boston. The Medical Director Non CF Pipeline functions as a scientific resource and medical partner of choice in assigned pipeline therapeutic areas (TA) for the North America Medical Affairs group, as well as other groups across the company. She or he will effectively contribute to the development of a global medical strategy for the TAs, which reflects regional needs. The Medical Director Non CF Pipeline interacts with internal Medical Affairs functions, including Glo

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Director of Policy & Reiumbursement

5 days ago
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Boston, MA Full-Time : Full-Time Job Description: The individual serving in this position will be a lead contributor to policy development in support of advancing Vertex’s federal and state advocacy agenda. This agenda includes, among other things, developing reimbursement policy strategies for marketed and pipeline products, supporting policy development aimed at securing access to therapies for patients (e.g., reducing the cost burden that patients encounter when accessing, maintaining certain patient protections). To accomplish this work, the Senior Director will partner closely with Vertex and GAPP leadership, team colleagues, including the Senior Directors leading the State Affa

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Scientist Bioanalysis

5 days ago
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Boston, MA Full-Time : Full-Time Job Description: The candidate will be responsible for the development of quantitative bioanalytical LC-MS/MS methods to support clinical and non-clinical studies within the Bioanalysis group. This individual has a background in analytical and separation science, in particular in the area of liquid chromatography-mass spectrometry (LC-MS) and sample extraction techniques (liquid-liquid, solid phase). Knowledge of GLP and familiarity with the conduct of method validations is beneficial. The candidate has a proven track record of scientific achievement and innovative thinking. A strong technical background in regards to LC-MS/MS methodology is required.

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Associate Director, Regulatory Affairs Operations

5 days ago
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Boston, MA Full-Time : Full-Time Job Description: The Associate Director of Regulatory Operations is responsible for the oversight of the preparation and submission of global Regulatory submissions. This individual will report to the Director of Regulatory Operations and assist in the management of any vendors supporting the regulatory submission process including creation and monitoring of KPIs and metrics. In addition to assigned projects, the Associate Director will be responsible for ongoing evaluation of Regulatory submission processes and standards and implementing improvements to each. This individual will direct workflow across internal/external teams for regulatory submissio

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Co-Op, Internal Audit

5 days ago
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Boston, MA Full-Time : Full-Time Job Description: Co-Op, Internal Audit The Vertex Summer Internship Program offers students the opportunity to learn about the pharmaceutical industry from a hands-on perspective. You will be working closely with and learning from some of the brightest people in the industry. When you join our internship program you should not be surprised to see that our environment is one that is innovative and team oriented, where collaboration is not just a word, and "we are fearless" is in everything we do. Students can expect to be challenged by their summer project plan, connect with other interns, and feel valued by the Vertex community. Not only will interns l

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Co-Op, Quality Assurance

5 days ago
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Boston, MA Full-Time : Full-Time Job Description: Co-Op, Quality Assurance The Vertex Summer Internship Program offers students the opportunity to learn about the pharmaceutical industry from a hands-on perspective. You will be working closely with and learning from some of the brightest people in the industry. When you join our internship program you should not be surprised to see that our environment is one that is innovative and team oriented, where collaboration is not just a word, and "we are fearless" is in everything we do. Students can expect to be challenged by their summer project plan, connect with other interns, and feel valued by the Vertex community. Not only will intern

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Co-Op, Procurement & Strategic Sourcing

5 days ago
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Boston, MA Full-Time : Full-Time Job Description: Co-Op, Procurement & Strategic Sourcing The Vertex Summer Internship Program offers students the opportunity to learn about the pharmaceutical industry from a hands-on perspective. You will be working closely with and learning from some of the brightest people in the industry. When you join our internship program you should not be surprised to see that our environment is one that is innovative and team oriented, where collaboration is not just a word, and "we are fearless" is in everything we do. Students can expect to be challenged by their summer project plan, connect with other interns, and feel valued by the Vertex community. N

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Co-Op, Global Organization and Leadership Development

5 days ago
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Boston, MA Full-Time : Full-Time Job Description: Co-Op, Global Organization and Leadership Development The Vertex Summer Internship Program offers students the opportunity to learn about the pharmaceutical industry from a hands-on perspective. You will be working closely with and learning from some of the brightest people in the industry. When you join our internship program you should not be surprised to see that our environment is one that is innovative and team oriented, where collaboration is not just a word, and "we are fearless" is in everything we do. Students can expect to be challenged by their summer project plan, connect with other interns, and feel valued by the Vertex co

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Real World Evidence (RWE) Informatics Lead

5 days ago
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Boston, MA Full-Time : Full-Time Job Description: Are you passionate about using real word evidence to drive the discovery, development and commercialization of break through medicines ? Do you have experience in leading an informatics group supporting RWE (Real World Evidence)? Are you looking for an opportunity to utilize your technical and leadership talent to explore and implement innovative RWE data management and analytics solutions ? You might be the person we are looking for. As we are rapidly growing our Real World Evidence Center of Excellence (RWE CoE) we need to establish a modern and scalable RWE informatics capability. The RWE Informatics lead will be responsible for the

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Senior / Principal Statistical Programmer

5 days ago
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Boston, MA Full-Time : Full-Time Job Description: The Senior / Principal Statistical Programmer will be responsible for providing hands-on support and technical guidance on clinical project teams. This individual will participate in the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for individual studies. This individual will participate in departmental and cross functional technology development and process improvement initiatives. Key Responsibilities: •Effectively designs and codes SAS programs for assigned clinical projects(s), consistently meeting objectives of the study •Codes compl

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Associate Director- Chemical and Materials Engineering

5 days ago
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Boston, MA Full-Time : Full-Time Job Description: Vertex is seeking a talented individual to join the Chemical and Materials Engineering group in Boston, MA. The successful candidate will be a highly productive, results-oriented individual, able to multi-task and generate and implement original ideas that contribute to the success, development, and scale-up of drug substance and drug product candidates. Excellent leadership, communication, and organization skills as well as a high level of technical aptitude and creativity are required for success in this position The successful candidate will: Be responsible for leading a group of engineers and chemists in defining, developing, a

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Co-Op, Corporate Insurance and Risk Management

5 days ago
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Boston, MA Full-Time : Full-Time Job Description: The Vertex Summer Internship Program offers students the opportunity to learn about the pharmaceutical industry from a hands-on perspective. You will be working closely with and learning from some of the brightest people in the industry. When you join our internship program you should not be surprised to see that our environment is one that is innovative and team oriented, where collaboration is not just a word, and "we are fearless" is in everything we do. Students can expect to be challenged by their summer project plan, connect with other interns, and feel valued by the Vertex community. Not only will interns learn about their day-t

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Scientist Analytical Development

5 days ago
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Boston, MA Full-Time : Full-Time Job Description: Vertex is seeking a talented individual to join our Analytical Development – Process Analytical Technology group in Boston, MA. As a member of the Process Analytics and Control team, this individual will also be a member of the industry leading continuous drug product manufacturing team supporting drug development programs at Vertex. The role will focus on both on-site support of GMP continuous manufacturing and PAT model development. Specific responsibilities include compliance to cGMPs, the development and validation of Process Analytical Techniques (PAT) methods and data models, statistical data analysis including the justification

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Senior Manager/Associate Director, Health Economics & Outcomes Research

5 days ago
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Boston, MA Full-Time : Full-Time Job Description: Vertex Pharmaceuticals is seeking a Senior Manager/Associate Director to join our Global Health Economics & Outcomes Research (HEOR) team. You will execute strategic plans to optimize the supporting evidence and value proposition of Vertex products through each stage of the development and commercial lifecycle. Your ability to work effectively in a highly matrix environment will help you to be successful. You will have a successful track record of executing HEOR studies and related publications, including in-depth pharmacoeconomic modeling, patient-reported outcomes analysis, and observational research. Your strong dedication to a

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Senior Manager/Associate Director of Regulatory Affairs, Submission Management

5 days ago
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Boston, MA Full-Time : Full-Time Job Description: The Senior Manager/Associate Director of Regulatory Submission Management, is responsible for the planning, managing and tracking of the regulatory portfolio of submissions and post submission plans for the various programs at Vertex. This role will be responsible for developing and maintaining comprehensive plans and reports that would include all major milestones and other key dates related to the filing of Vertex programs. The plans would be used within regulatory to plan submission activities, resources and budget. In addition, the plans will need to be integrated cross-functionally to ensure project team alignment on major milesto

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Intern, Human Assay Technologies

7 days ago
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Job Description Vertex Pharmaceuticals is seeking a highly motivated intern to join our Research team located in Boston, MA. The ideal candidate will be responsible for supporting human cell assay ...

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Associate Director of Statistical Programming

8 days ago
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Boston, MA Full-Time : Full-Time Job Description: Position will direct, manage and coordinate the activities of Statistical Programming staff assigned to projects. Position will lead statistical programming activities for Phase II and III trials of Next Generation CF compounds; code complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDISC SDTM and ADaM format; provide guidance on the resolution of highly complex clinical trial reporting problems within budget and time line constraints, while assuring high quality standards; identify problems and develop global t

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Sr. Sourcing Manager

9 days ago
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Boston, MA Full-Time : Full-Time Job Description: Primary activities for this position include Category management for Direct category spend, Market Analysis, RFx development, negotiation planning, competitive price and cost analysis, financial analysis, contract development and on-going supplier management. Additional focus on optimization of internal sourcing processes, work flows and interfaces in effort to reduce time of delivery and costs in support corporate objectives and industry best practices. This individual will be expected to deliver value and competitive advantage to the business as measured by customer satisfaction, project execution, value improvement, innovation, and

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Data Engineer

9 days ago
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Boston, MA Full-Time : Full-Time Job Description: Are you great at breaking things? Do you enjoy solving logic puzzles and working with large data sets? Do you have experience in data engineering and/or data science and want to apply your knowledge to high-value business questions in biotech? Vertex’s Data Strategy and Solutions Team is seeking an associate data engineer who is adept at testing pipelines and systems to find bugs and data inconsistencies. As an individual contributor on this team, you will work closely with data scientists and data engineers to develop and implement test plans that ensure data quality throughout product architectures. While data quality assurance will

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Technical Operations Manager - Automation / Data Integration

10 days ago
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Boston, MA Full-Time : Full-Time Job Description: The Manager - Automation is an exciting opportunity to join Vertex’s growing Technical Operations team and facilitate rapid commercialization of new products utilizing continuous manufacturing technology while working with first-in-class commercial operations and external suppliers in an industry-leading Quality by Design (QbD) environment. Vertex Pharmaceuticals currently has three significant commercial products in addition to a robust pipeline with multiple new molecules in various stages of clinical development. The Manager delivers reliably and responsibly on independent activities and is responsible for execution and oversight o

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Associate Director/Director, Pricing & Reimbursement

11 days ago
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Boston, MA Full-Time : Full-Time Job Description: Vertex currently operates at the forefront of rare disease scientific innovation and has successfully developed and commercialized three breakthrough medicines for Cystic Fibrosis (CF) patients. The announcement of positive data for our Triple Combination CF product and our long-term dedication to advancing innovative therapies in other serious diseases has further enhanced our need to grow and expand as an organization. In the context of an increasingly complex and challenging Global market access environment, it is necessary to deliver groundbreaking pricing & reimbursement solutions to allow our medicines to reach patients fas

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Lead Mobile Developer

11 days ago
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Boston, MA Full-Time : Full-Time Job Description: The GIS Commercial systems team is looking for an enthusiastic, skilled a mobile developer to build and maintain its growing set of apps in support of its global commercial expansion. Candidates should be able to show a history of completed applications, either available for sale individually in the App Store or available for enterprise customers. He or she will work directly with end users, internal IT, and creative agencies to deliver internal (in support of internal Vertex operations) and external (to be used by patients and other external users) mobile applications. The successful candidate will have proven experience working in a

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Senior Manager/Associate Director, Regulatory Affairs - AD/Prom

12 days ago
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Boston, MA Full-Time : Full-Time Job Description: The Senior Manager/Associate Director, under the direction of the Director of Commercial Regulatory Affairs within Global Regulatory Affairs, will be responsible for regulatory strategy and operational leadership in the area of product and disease state communication for one or more Vertex products and development programs. This individual will be responsible for ensuring that product and disease state communications meet the needs of the organization and are consistent with applicable laws, regulations, and guidelines in the U.S. This is an exciting opportunity for a seasoned regulatory professional to contribute to the ongoing develo

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Technical Operations Manager (Drug Product Manufacturing)

13 days ago
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Boston, MA Full-Time : Full-Time Job Description: The Manager, Drug Product Manufacturing is an exciting opportunity to join Vertex’s growing Technical Operations team and facilitate rapid commercialization of new products utilizing continuous manufacturing technology while working with first-in-class commercial operations and external suppliers in an industry-leading Quality by Design (QbD) environment. Vertex Pharmaceuticals currently has three significant commercial products in addition to a robust pipeline with multiple new molecules in various stages of clinical development. The successful candidate will have the opportunity to add significant value in three areas: Commercial p

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SEO Specialist PropertyBase in Boston , MA seeks qualified SEO Coordinator. This role is responsible for analyzing, reviewing and implementing websites that are

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Senior Software Engineer, Web

26 days ago
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Boston , MA - Engineering & Technology - Engineering Architecture We're reimagining sports and technology. DraftKings is bringing sports fans closer to the games

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Technical Lead, Data Science Engineering

26 days ago
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Boston , MA - Engineering & Technology - Engineering Architecture We're reimagining sports and technology. DraftKings is bringing sports fans closer to the games

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Senior Software Engineer, iOS

26 days ago
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Boston , MA - Engineering & Technology - Engineering Architecture We're reimagining sports and technology. DraftKings is bringing sports fans closer to the games

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Psychiatry, No Weekends, near Boston, MA - PERM JOB

about 1 month ago
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Located near Boston, MA About the GROUP: A well-established, highly respected group that has ... Psychiatry - mostly pharmaceutical focused, not therapy * Schedule: Monday - Friday * Patient ...

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Reimbursement Business Advisor -Neuro/Uro - Boston, MA

about 1 month ago
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AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device ...

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MASSACHUSETTS Licensed PHARMACIST - Boston Area

about 2 months ago
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Massachusetts LICENSED PHARMACISTS - Boston Area Are you a Pharmacist who is: * Clinically ... Dual licensure in MA/RI or MA/CT a definite plus! Please note: Prior experience in a clinical ...

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Access & Reimbursement Manager- Boston MA (Remote)

5 months ago
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The ARM will need to coordinate cross functionally within Novartis Pharmaceuticals Corporation (NPC) i.e. Field Sales, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade ...

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Physician - Family (Boston,MA)

8 months ago
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Prescribes pharmaceuticals, other medications, and treatment regimens as appropriate to assessed medical conditions. Refers patients to specialists and to relevant patient care components as ...

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