Top 8 Medical writer part time Jobs

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Senior Regulatory Medical Writer - Fractional (Remote)

Penfield Search Partners
Fairfield, CT

Quick Apply

Job Details

Contract

Qualifications

Technical editing
FDA submissions
Medical writing
Clinical study protocols and reports
Content creation for technical audiences
Investigational new drug (IND) applications
Compliance documentation
Regulatory submission editing and review
Communication with regulatory authorities for clinical trials
Technical writing quality assurance
Senior level
Document change management
Cross-functional collaboration
Cross-functional communication

Full Job Description

Contact: Alexandra Spink - [email protected]
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

Quick Apply

Refine Your Search

medical writer part time jobs

Senior Regulatory Medical Writer - Fractional (Remote)

Freelance Medical/Grant Writer

Part Time Medical Writer - Medicine

Lead Technical Writer, Clinical AI/ML & SaMD

Scientific Writer/Editor - ON-CALL

Temporary Video Editor, Men's Health and Women's Health

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