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Senior Regulatory Medical Writer - Fractional (Remote)

Fairfield, CT

Posted: 06/15/2026 Industry: Biotech/Pharmaceutical Job Number: 6176

Job Description

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

We are seeking a Senior Regulatory Medical Writer to provide fractional, on-demand support for regulatory submission activities. This role focuses on independently updating and finalizing regulatory documents to support ongoing agency interactions and submission deliverables, working alongside internal and contract writers.

Scope of Work
  • Independently update, revise, and finalize regulatory documents, including protocol and IB
  • Support preparation and maintenance of protocol amendments, submission support documents, and related deliverables within Common Technical Document (CTD Modules 2–5) across the submission lifecycle (responses, amendments, briefing packages)
  • Ensure scientific accuracy, clarity, consistency, and compliance across all regulatory documents
  • Collaborate with internal teams and contract writers to ensure timely delivery aligned with regulatory and quality standards
  • Support intermittent workload demands (~10–15 hours/week during active project periods)
Qualifications
  • Regulatory medical writing experience supporting IND, CTA, NDA, and/or BLA submissions
  • Strong familiarity with Common Technical Document (CTD) structure and regulatory submission lifecycle (e.g., responses, amendments, briefing packages)
  • Ability to work independently with minimal oversight in a fast-paced, cross-functional environment
  • Strong attention to detail with demonstrated ability to ensure scientific and regulatory quality standards
  • Proven collaboration experience with regulatory, clinical, and medical writing teams

Meet Your Recruiter

Alexandra Spink, BSN, RN
Director, Clinical Recruitment

With a dedication to serving others, Alexandra spent many years caring for tiny patients and their families as a Neonatal ICU Registered Nurse prior to joining Penfield as a Clinical Recruitment Specialist in their Contract Staffing Division. Transitioning into the staffing realm, she now seamlessly merges her clinical background with her fervent desire to assist others. Today, she utilizes this unique fusion to facilitate the connection of top-tier talent to promising opportunities within the pharmaceutical and biotech industries.

 

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About Fairfield, CT

Ready to take your career to new heights? Explore job opportunities in beautiful Fairfield, Connecticut, where coastal charm meets bustling city life. This vibrant area offers a perfect blend of picturesque beaches, historic landmarks like the Fairfield Museum, delectable local cuisine, and a thriving arts scene including the Regina A. Quick Center for the Arts. With proximity to New York City and easy access to outdoor recreational activities at places like Lake Mohegan, Fairfield is an ideal location for professional growth and work-life balance. Don't miss out on the chance to join this dynamic community – browse our job listings today!