Senior Medical Writer, Promotional Review
Company: Thermo Fisher Scientific
Job Title: Senior Medical Writer, Promotional Review
Job ID: R-01344083
Location: Massachusetts, USA (Remote)
Job Category: Clinical Research / Medical Writing / Medical Affairs
Employment Type: Full-time
Work Mode: Fully Remote
Work Schedule: Standard (Monday–Friday)
Job Summary
Thermo Fisher Scientific is hiring a Senior Medical Writer, Promotional Review to support medical review of promotional and non-promotional scientific materials, ensuring compliance with FDA-OPDP requirements, medical accuracy, and regulatory standards. The role also includes medical information writing, medical affairs support, mentorship, and strategic promotional review consulting.
Key Responsibilities
Promotional Review & Medical Affairs
Review promotional and non-promotional medical materials for:
Clinical accuracy
Scientific accuracy
Regulatory compliance
Tone and audience appropriateness
Ensure compliance with:
FDA-OPDP requirements
Medical/Legal/Regulatory (MLR) review standards
Promotional Review Committee (PRC) expectations
Provide strategic recommendations and risk mitigation guidance.
Review:
FDA communications
Warning/action letters
Regulatory promotional guidance
Support:
Medical affairs materials
Field force communication content
NCCN submissions
Strategic medical communication planning
Medical Information Writing
Draft and review:
Standard Response Letters
FAQs
Product Dossiers
Clinical study summaries
Review routine documents prepared by junior writers.
Ensure documentation quality and process compliance.
Develop best practices for medical writing workflows.
Leadership & Mentorship
Train and mentor junior writers and program managers.
Support document development processes and system usage.
Provide therapeutic area guidance where needed.
Required Qualifications
PharmD or equivalent healthcare/scientific qualification
Equivalent education + experience combinations may be considered.
Required Experience
2–3 years of experience in promotional review
Experience as part of:
Medical / Legal / Regulatory (MLR) teams
Promotional Review Committees
Strong platform experience with:
Veeva PromoMats
PRC / CRM promotional review systems
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