Director, Regulatory Affairs - Global Labeling
Gilead SciencesFull Time
Expert & Leadership (9+ years)
Candidates must possess a Bachelor's degree in a scientific discipline or equivalent, with an advanced degree being preferred. A minimum of 8 years of regulatory writing experience in the pharmaceutical/CRO industry is required, along with proven experience managing complex medical writing projects and extensive experience in Phase 3 CSRs and/or protocol development. EU CTR experience is preferred, as is experience with structured content management systems, AI-driven content creation, and Natural Language Generation. Excellent organizational, program management, leadership, and communication skills are essential, along with extensive knowledge of regulatory guidelines and drug development processes. The ability to work independently and adapt to changing requirements is also necessary.
The Principal Medical Writer will lead the development, writing, and editing of complex clinical and regulatory documents, ensuring alignment with regulatory guidelines and company standards. They will collaborate with cross-functional teams to ensure accurate and timely document completion, provide strategic input on document content and structure, and mentor junior medical writers. The role involves managing multiple writing projects simultaneously and staying current with industry trends and regulatory requirements.
Provides life sciences products and services
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.