Authors complex clinical regulatory documents (e.g., clinical study protocols, clinical study reports, investigator's brochures, documents to support meetings with regulatory agencies, and sections of marketing authorization applications) in partnership with key stakeholders Serves as the lead Medical Writing Scientist for complex or pivotal clinical studies for multiple

The Executive Director, Pain Global Strategy will have global responsibility to build the Global Medical strategy for Pain assets. Communicate the Global Medical strategy to partner functions for further strategic and tactical guidance. Execute the Global components of the medical strategy plan. Partner with Clinical Development, HEOR, RWE, Regional Medical Affairs and pa

The Senior Medical Director, T1D (Transplant Immunology/ Endocrinology) will define all aspects of T1D translational strategy and will be accountable for delivering key translational milestones. They will work with cross functional multidisciplinary teams to define overall translational strategy as well as clinical trials strategy, design and execution, and may serve as t

Function as a key partner to the Marketing lead and provide objective perspective and insights Formulate a comprehensive insights generation plan to address a spectrum of business questions using the appropriate methodology Independently design and execute primary market research that addresses key business questions Define data analytics needed to answer ongoing business

Vertex is seeking an experienced Senior Research Associate to join the Cell and Genetic Therapies (CGT) type 1 diabetes genetic engineering team in Boston, MA. The group is dedicated to discovering and advancing the next generation of cell therapies for the treatment of type 1 diabetes. The candidate will have the opportunity to develop gene editing approaches for stem ce

Work with cross functional team with oversight by the Medical Lead to conduct clinical studies, including clinical and safety data review, site interface on clinical study content, preparation of meeting materials, communication plans (e.g., administrative letters, protocol amendments, protocol deviations), safety and medical monitoring, preparation of status update repor

Management of vendors and vendor process including onboard, risk based and phase appropriate qualification oversight, and ongoing monitoring. Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions Provides tactics to address compliance gaps or determines enhancements to cross functional vendor quality man

Leads the development of regulatory strategy for assigned projects/regions in development (from first in human to post marketing application stage) outlined in Global Regulatory Strategy Documents Represents GRA on core development functional teams, project teams, and collaborate with regional leaders and teams to ensure unified regulatory input into clinical programs and

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

Maintain a high level of productivity in the laboratory setting Develops and executes clear synthetic routes using state of the art synthetic methodologies Primarily responsible for executing organic syntheses in a timely, efficient, and independent manner Create and interpret SAR with a clear understanding of the biological data Organize and triage efforts to stay consis

Oversee material requirements and lead the device raw material planning process for the providence, RI site for BOM and non BOM materials. Partner with CMC, Procurement and Strategic Sourcing to ensure supply and solve supplier and materials related issues. Manage direct and indirect materials for manufacturing activities, as well as materials for packaging/labeling and s

Responsible for all aspects of warehouse and materials management functions for the GMP/non GMP materials within the Boston and Cambridge warehouses (internal and external). Coach and lead a team of material handlers. Design organizational structure as needed. Act as Business Process Owner for materials management, collaborating with other Material Management leads within

The Senior Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Senior Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product manufacturing and disposition. This is an on site position on the 2nd shift. KEY DUTIES AND RESPONSIBILITIES Review batch data,

Provide technical input into environmental/facility/process monitoring program deviations and contamination events to determine impact to batch disposition and design/implement effective corrective and preventative actions to prevent future disruptions. Strong collaboration in the resolution of manufacturing investigations related to aseptic control events Support the des

Prepare a wide range of financial analyses to inform DST decisions on investments. Develop and maintain financial models covering all aspects of biopharmaceutical research, development, manufacturing, and commercialization. Provide Strategy Finance input into regular financial planning processes (Annual Budget, Forecasts, Long Range Plan), for assigned Disease Areas. Mana