Sr Manager, Medical Writing
New
J
JobgetherBiotechnology, Pharmaceuticals
Based in the United StatesFull-TimeManager
SalaryNational salary range of $170,000–$190,000 USD annually
Apply NowOpens the employer's application page
Job Details
- Experience
- 10+ years
- Required Skills
- Project Management
Requirements
- Advanced degree such as PhD, PharmD, MD, MS, or equivalent in Life Sciences, Pharmacy, Medicine, or a related scientific discipline is preferred.
- 10+ years of medical writing experience within the biotechnology or pharmaceutical industry.
- Extensive experience independently authoring FDA regulatory documents, including briefing packages, meeting requests, and clinical development documentation.
- Demonstrated experience preparing FDA briefing documents supporting RMAT, Breakthrough Therapy Designation, or comparable regulatory interactions.
- Strong experience developing clinical protocols and protocol synopses.
- Thorough understanding of FDA regulations, ICH guidelines, and Good Clinical Practice (GCP) requirements.
- Experience in autoimmune diseases such as Stiff Person Syndrome, Myasthenia Gravis, Progressive Multiple Sclerosis, or related therapeutic areas is highly valued.
- Ability to manage multiple complex projects independently, prioritize competing demands, and consistently deliver high-quality work under tight timelines.
- Exceptional scientific writing and editing skills, with the ability to communicate complex clinical and scientific concepts clearly and accurately.
- Strong project management and organizational capabilities, including experience coordinating complex document review cycles.
Responsibilities
- Independently author, edit, and finalize complex regulatory and clinical development documents, ensuring scientific accuracy, consistency, clarity, and compliance with applicable requirements.
- Lead the preparation of FDA briefing documents and related materials supporting regulatory interactions, including RMAT, Breakthrough Therapy Designation, and other Agency engagements.
- Develop clinical protocol synopses and contribute to the preparation and refinement of full clinical study protocols.
- Collaborate closely with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Translational Medicine, and other cross-functional partners to gather, interpret, and synthesize complex scientific and clinical information.
- Translate technical and clinical data into clear, coherent, and strategically positioned regulatory narratives.
- Own document development timelines, proactively coordinating reviews, resolving comments, incorporating stakeholder feedback, and ensuring high-quality delivery against aggressive deadlines.
- Ensure regulatory and clinical documents align with FDA guidance, ICH guidelines, GCP requirements, and applicable internal standards.
- Participate in document planning meetings and provide strategic input on document structure, messaging, positioning, and regulatory presentation.
View Full Description & ApplyYou'll be redirected to the employer's site
