Independently performs content, editing, and formatting QC of moderately complex regulatory and clinical study documents, which may include complex CSRs, complex protocols, Investigator Brochures, and single study Module 2 summaries Ensures QC reviewed documents are compliant with MWS Style guide and templates Troubleshoots MWS processes, tools, and technologies and may s

Sets Medicinal Chemistry Scale Up strategic direction to enable API route development to support project goals. Encourages and enables cross functional collaboration with Medicinal and Process Chemistry, Analytical Chemistry and Development, Formulation, and Drug Metabolism to support API deliveries for pre clinical evaluation Provides mentorship supporting scientific and

Within assigned area, designs, develops and executes the technical/statistical infrastructure for the conduct and evaluation of clinical trials, observational studies, or real world data (RWD) investigations, including related areas/activities. Participates in regular Study Execution Team (SET) team meetings as the functional representative. Works under supervision to aut

The Corporate Finance Associate Director is a key member of Vertex's Finance organization, supporting the annual budgeting and monthly forecast processes including the analysis, preparation, and communication of financial results to the CFO leadership team. The role will collaborate closely across Finance and other teams to identify and deliver actionable insights that dr

Lead all activities related to the engagement and account management of assigned accounts i.e., national/regional wholesalers and distributors and/or national specialty and retail community pharmacies. Negotiate, implement and manage Specialty Pharmacy Master Service Agreements (MSAs), Enhanced Service Agreements (ESA), Retail Stocking Agreements (RSA), and Distribution S

The Process Dev Engineering Scientist will be part of a team responsible for the development, optimization, and characterization of drug product manufacturing processes for cell based products and combination products. This is a lab based role focusing on formulation development, process development, scale up, tech transfer, and evaluation of next generation drug product

The Process Engineering Manager delivers reliably and responsibly on independent activities and is responsible for execution and oversight of internal or external manufacturing operations in a technical area. The incumbent is a key participant on internal and external cross functional teams within their technical area for one or more supplier(s). The role assists in maint

Co develop andexecute the commercial brand strategy and tactical plan within a specified local market in coordination with Marketing and Advocacy teams, among others. Participate in territory/division/regional account planning and provides input into local market decisions and resource needs. Upon product approval, provide patients and caregivers with approved product res

Vertex has established a research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat and even cure several of the diseases Vertex is focused on, including sickle cell disease, Duch

Build and manage a manufacturing engineering team for DSDP cells and combination products Act as primary technical and engineering manufacturing lead design reviews, documentation with focus on designing for manufacturability. Implement, propose and drive the implementation of Drug Product Device and manufacturing engineering controls by integrating Vertex QMS, production

The GMP Operational Associate Director is recognized as an expert internally in the principles and application of quality assurance and compliance. The GMP Operational Associate Director will provide QA support of manufacturing operations, oversee sterilization processes and microbiological testing, and serve as a Product Quality Lead for the activities supporting Cell &

Provides comprehensive expertise and guidance in designated therapeutic area(s) and Vertex medicines Leads a team of physicians and scientists to create and execute appropriate medical affairs plans and tactics supporting designated therapeutic area(s) and Vertex medicines Develops and maintains professional relationships with local Health Care Professionals, and with loc

The Package Engineering Senior Manager is an emerging professional within the department. This role delivers on complex outsourced manufacturing activities in Packaging and is responsible for ensuring positive and effective relationships with all stakeholders. This role will focus primarily on commercializing cell & gene therapy products and preparing pipeline products fo

Vertex has established a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat and even cure several of the diseases Vertex is focused on, including sickle cell disease,

The Associate Director, Information Systems Management entails providing risk based oversight to Computerized Systems Life Cycle activities across broad spectrum of technologies ranging from Automated Systems to Enterprise Wide systems and Software as a Service (SaaS) solutions. This role ensures risk based, overall integrity of electronic data across all stages of data l