Regulatory Medical Writer

Fairfield, OH - USA

Monthly Salary: Not Disclosed

Posted on: 3 days ago

Vacancies: 1 Vacancy

Job Summary

Job Description

Contact: Alexandra Spink -
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

Job Description Contact: Alexandra Spink - 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 ...