Medical Writer, Regulatory – Contract

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

📋 Description

• Take the initiative to author, edit, and finalize intricate regulatory documents that support clinical development programs.

• Spearhead the creation of FDA briefing documents that facilitate RMAT, Breakthrough Therapy Designation, and other Agency engagements.

• Formulate clinical protocol synopses and assist in the comprehensive development of protocols.

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

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

• Ensure that all documents adhere to FDA guidance, ICH guidelines, and internal company standards.

• Engage in document planning meetings and provide strategic insights on structure, messaging, and regulatory presentation.

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

⛳️ Requirements

• A minimum of 10 years of medical writing experience within the biotechnology or pharmaceutical sector.

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

• Proven experience in developing FDA briefing documents related to 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 manage several projects independently with minimal oversight while adhering to tight timelines.

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

• Experience in dynamic, cross-functional clinical development settings.

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

🏝️ Benefits

• Flexible working hours tailored to project demands.

• Potential for contract extension depending on business needs and regulatory timelines.

• Opportunity for remote work within the United States.