Sr Manager, Medical Writing

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr Manager, Medical Writing based in the United States.

This is a senior individual contributor role supporting clinical development programs through high-quality regulatory and scientific writing. You will independently develop complex documents that support FDA interactions, clinical studies, and important development milestones. The role offers broad cross-functional exposure, partnering with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, and Translational Medicine teams. You will help shape regulatory narratives and ensure scientific information is presented with clarity, accuracy, and strategic impact. The position is particularly suited to an experienced medical writer with strong expertise in autoimmune disease and advanced cell therapy or biopharmaceutical development. You will operate in a fast-paced, collaborative environment where ownership, scientific rigor, and the ability to deliver against demanding timelines are highly valued.

Accountabilities:: 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.

Anticipate writing and project risks, identify potential gaps or inconsistencies, and proactively recommend solutions.

Support additional regulatory, clinical, and development documents as program priorities and business needs evolve.

Maintain a high level of independence while effectively communicating progress, challenges, priorities, and recommendations to relevant stakeholders.

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.

Excellent interpersonal and communication skills, with the ability to influence and collaborate effectively across diverse functional teams.

Demonstrated ability to work successfully in fast-paced, cross-functional clinical development environments with minimal supervision.

Strong attention to detail, scientific judgment, and commitment to quality and regulatory compliance.

Benefits:

National salary range of $170,000–$190,000 USD annually , with actual compensation determined by factors including education, experience, tenure, skills, abilities, internal equity, and market data.

Eligibility for a performance-based bonus.

Participation in an employee stock plan.

Comprehensive employee benefits.

Fully remote work environment within the United States.

Opportunity to contribute to innovative clinical development programs addressing significant unmet needs in autoimmune disease.

Collaborative, cross-functional environment with exposure to clinical development, regulatory strategy, and advanced therapeutic programs.

Opportunity to play a meaningful role in supporting important regulatory milestones and advancing novel treatments toward patients.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1