decisions at the TA Strategy Team and Global Medicine Team meetings Generally, the role may include managerial... of regulatory strategy, therapeutic area and other functional strategies. Specifics of the specialized role The EMD...
that report indirectly to the Executive Medical Director. The EMD may support development of regulatory strategy, therapeutic area... and Global Medicine Team meetings. Generally, the role may include managerial responsibilities over Senior Director, Medical...
Affairs, Regulatory, Legal, Development Quality, and other internal partners. Manage external vendor performance, including...-functional and vendor relationships Strong working knowledge of ICH-GCP, global regulatory requirements, and local trial...
Affairs, Regulatory, Legal, Development Quality, and other internal partners. Manage external vendor performance, including...-functional and vendor relationships Strong working knowledge of ICH-GCP, global regulatory requirements, and local trial...
, and data generated by external laboratories meet Vertex, global regulatory, and data integrity standards. Key Duties...Job Description General Summary: The Associate Director, GMP Operational Quality will provide leadership...
. They will collaborate closely with Medical Affairs, HEOR/RWE, Global Medical, Global Publications, R&D, Clinical Development, Regulatory... scientific publications and communications strategy, ensuring consistency, quality, and integration across U.S. and global...
to and executing on the clinical strategy, serving as Medical Monitor, supporting regulatory submissions, and collaborating and leading...: Work with regulatory affairs, clinical operations, pharmacovigilance, biostatistics. medical affairs, and commercial teams...
Job Title: Associate Director, Scientific Communications Lead (Hematology, Global Medical Affairs Oncology) Location... a career grounded in purpose and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team...
and potential future indications and assets is looking to hire a Director Medical Science Liaison.... This is what you will do: Reporting directly to the Executive Director, Therapeutic area Medical Lead, The Director, Metabolic MSLs will be the National...
affairs. By leading evidence generation activities, the Scientific Director will enhance the understanding of the fertility... America Evidence and Value Development team, Clinical Development (R&D), and Global Medical Affairs, to develop and implement...
through regulatory strategy, legislative and legal action, and intergovernmental coordination. Serving as the Environment... on legislative affairs and policy. The Director interacts with all segments of Boston’s municipal government and the Boston community...
through regulatory strategy, legislative and legal action, and intergovernmental coordination. Serving as the Environment... on legislative affairs and policy. The Director interacts with all segments of Boston’s municipal government and the Boston community...
Develop and implement a comprehensive US patient affairs strategy that aligns to US medical affairs and enterprise-wide goals... underserved therapeutic areas and make patients the focus of every strategic decision. Role Summary The Senior Director...
or pharmacovigilance audit program, hosting/leading regulatory inspections, investigations and remediation activities on a global level... Associate Director, Clinical & Quality Process Compliance is responsible for ensuring the quality of processes and product...
The Medical Director (Clinical Development, Regulatory and Safety), will hold an expert position within the Amyloidosis... pharmacology, translational medicine, regulatory, biostatistics, safety, CMC, medical affairs, and commercial partners. Analyze...
Job Description General Summary: The Clinical Development Medical Director will serve as the Medical Lead... for Vertex clinical trials, working with cross-functional multidisciplinary study teams on clinical trial strategy, design...
· Interact cross-functionally with Commercial, Medical Affairs, Drug Safety, Regulatory, Legal, Compliance and Finance to develop... not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your role: As the Director Field...
regulatory teams and external partners to deliver global submissions and maintain compliance under design control... with diagnostic companies. Hands-on experience with global regulatory pathways (FDA IDE/PMA; EU IVDR CPS/performance requirements...
regulatory teams and external partners to deliver global submissions and maintain compliance under design control... with diagnostic companies. Hands-on experience with global regulatory pathways (FDA IDE/PMA; EU IVDR CPS/performance requirements...
. Collaborate with Global Project Heads, Clinical Research Director, Safety Officer and Pharmacovigilance, Translational Medicine..., Regulatory Affairs, Biostatistics, Clinical Study Units, Medical Affairs, and CROs to optimize study design and execution...