The Audit and Inspection Management Manager is responsible for the execution of audit and inspection management assigned activities, inclusive of internal and external processes, contributing to and executing audit plans, supporting inspection readiness activities, on site and remote inspection support, and overall conduct of inspections. This role has responsibility for

The Associate Director, RWE, is primarily an individual contributor role, working closely with the Director/Senior Director/Executive Director/VP, RWE, to develop observational research, to inform internal and external stakeholders on natural history (NH) of disease, and real world outcomes within a therapeutic area. The Associate Director, RWE, works cross functionally t

Serve as a DMPK functional lead in a multidisciplinary project team to advance Vertex drug discovery and development programs from early discovery to late development Collaborate with medicinal chemists to design drug candidates avoiding metabolic liabilities and evaluate and select drug candidates based on potency in the biological target and on overall ADME (absorption,

Responsibility to build and execute the Global Medical strategy for key CF products. Communicate the Global Medical strategy to partner functions and senior leaders 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 partner functions to identify

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

Establishes meaningful and professional relationships within key accounts across multiple layers of the hospital system (key hospital medical and administrative staff, pharmacies, formulary decision makers and KTLs) Develops and maintains expertise on the product's clinical attributes and patient unmet need and educates healthcare professionals on product use in appropria

Establishes meaningful and professional relationships within key accounts across multiple layers of the hospital system (key hospital medical and administrative staff, pharmacies, formulary decision makers and KTLs) Develops and maintains expertise on the product's clinical attributes and patient unmet need and educates healthcare professionals on product use in appropria

Establishes meaningful and professional relationships within key accounts across multiple layers of the hospital system (key hospital medical and administrative staff, pharmacies, formulary decision makers and KTLs) Develops and maintains expertise on the product's clinical attributes and patient unmet need and educates healthcare professionals on product use in appropria

The Director, Manufacturing Technical Services, Quality Assurace is responsible for the quality oversight of Contract Manufacturing Organizations (CMOs) and Contract Test Labs (CTOs) for Cell & Genetic Programs through the lifecycle development process. This includes quality oversight for the selection, qualification and routine monitoring of Contract manufacturers and la

The Senior GCP Operational Quality Manager conducts quality assurance oversight and management activities of clinical trial operations to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols and Vertex policies and procedures. These activities include the development and execution of study level a

The Associate Director, Regulatory CMC executes multi product global regulatory CMC strategies for cell therapy combination investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages the interactions with Health Authorities for CMC topics. This role also provides regulatory guidance to various cross function

The Formulation Research Scientist will work with other scientists dedicated to advancing drug candidates from exploratory development through commercial line extension in a Quality by Design (QbD) environment using lab based and computational tools to design and select dosage forms and manufacturing process. Key Duties and Responsibilities Develop dosage forms for clinic

As a key member of the Corporate/North American accounting department, the General Ledger Senior Accountant II partners with members of the accounting and finance departments as well as teams across other departments throughout the Company. The position provides exposure to key accounting and reporting areas and offers development opportunities that can lead to advanced r

Plan packaging based off study design. This includes packaging design to be used Bottles vs blisters and qty of supplies to produce Plan production activities Following packaging completion, responsible for determine inventory release timing and stocking of depots taking into consideration the following but not limited to expiry, countries, key study milestone dates, numb