Regulatory Medical Writer
Penfield Search PartnersFairfield, CT
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Job Description
Contact: Alexandra Spink -
teamnt@penfieldsearch.com
No 3rd party candidatesWe 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.
- 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
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This job at Penfield Search Partners is located in Fairfield, CT, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
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