Senior Manager, Medical Writing

This is a fully remote position, open to applicants in United States.

📋 Description

• Independently create, revise, and finalize intricate regulatory documents that support clinical development initiatives.

• Lead the preparation of FDA briefing documents for RMAT, Breakthrough Therapy Designation, and other interactions with regulatory agencies.

• Develop synopses for clinical protocols and contribute to the comprehensive clinical study protocols.

• Collaborate with teams across Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Translational Medicine, and other functional areas.

• Oversee document development timelines, reviews, cross-functional feedback, and delivery schedules.

• Ensure that documents comply with FDA guidance, ICH standards, and company policies.

• Participate in document planning meetings and offer strategic insights on structure, messaging, and regulatory presentation.

• Assist with additional regulatory and clinical documents as business requirements change.

⛳️ Requirements

• An advanced degree (PhD, PharmD, MD, MS, or equivalent) in Life Sciences, Pharmacy, Medicine, or a related scientific field is preferred.

• A minimum of 10 years of medical writing experience in the biotechnology or pharmaceutical sectors.

• Extensive experience in independently authoring FDA regulatory documents, including briefing packages, meeting requests, and clinical development documents.

• Proven experience in developing FDA briefing documents for RMAT, Breakthrough Therapy Designation, or similar regulatory interactions.

• Strong background in writing clinical protocols and protocol synopses.

• Comprehensive understanding of FDA regulations, ICH guidelines, and GCP requirements.

• Capability to independently manage multiple projects with minimal oversight while adhering to tight deadlines.

• Outstanding scientific writing, editing, communication, and project management abilities.

• Experience in fast-paced, cross-functional clinical development settings.

• Preference for candidates available to work West Coast hours.

🏝️ Benefits

• Eligibility for bonuses.

• Health and other benefits.

• Opportunity to participate in the Company’s stock plan.