Regulatory Medical Writer

Job Description

Contact: Alexandra Spink - aspink@penfieldsearch.com
No 3rd party candidates

We are seeking an experienced Regulatory Medical Writer to provide fractional support for the development of complex regulatory submission documents. Requires a writer who can lead document strategy and author high-level regulatory materials. The ideal candidate will serve as a subject matter expert (SME) and program lead, responsible for designing, developing, and managing key regulatory documents in support of regulatory submissions.

This is a remote, flexible role with part-time hours to start, expected to scale up.

Key Responsibilities:

• Author and lead the development of regulatory submission documents, including: Regulatory briefing books, eCTD modules and other complex regulatory documentation
• Develop document strategies, structure, and messaging aligned with regulatory objectives.
• Serve as a SME for regulatory writing across programs.
• Act as the program lead for assigned writing projects, coordinating cross-functional input.
• Translate complex scientific and clinical data into clear, compliant regulatory narratives.
• Collaborate with clinical, regulatory, biostatistics, and program leadership teams.
• Ensure documents meet regulatory agency expectations and submission standards.

Qualifications:

• Extensive regulatory medical writing experience within pharma or biotech
• Proven experience authoring regulatory submission documents, including briefing books and eCTD modules
• Demonstrated ability to develop document strategies and lead authoring from concept to submission
• Strong experience handling highly complex regulatory documentation
• Excellent communication, leadership, and stakeholder management skills
• Ability to function as a program lead across cross-functional teams