🧾 Job Title: Principal Medical Writer (Regulatory MW)
Location: Remote – North Carolina, USA
Job ID: R-01332392
Job Type: Full-time
Category: Clinical Research
Remote Status: Fully Remote
Work Schedule: Standard (Mon–Fri)
Environment: Office
🌍 About the Role
Join Thermo Fisher Scientific, where meaningful work impacts global health. As part of our PPD® clinical research portfolio, you’ll help develop, document, and deliver life-changing therapies. The Principal Medical Writer leads regulatory medical writing initiatives—ensuring accuracy, quality, and compliance in all documentation for global clinical research programs.
🧠 Key Responsibilities
Primary Functions
Serve as lead author for regulatory and clinical documents such as:
Clinical Study Reports (CSRs)
Study Protocols
Investigator Brochures (IBs)
Marketing Applications (MAAs)
Investigational New Drug (IND) submissions
Coordinate all aspects of medical writing from planning to delivery of final drafts.
Summarize and interpret clinical study data clearly and accurately.
Ensure documents meet regulatory, scientific, and company quality standards.
Advisory & Mentorship
Provide training and guidance to junior medical writers and project managers.
Advise teams on document strategy, regulatory requirements, and best practices.
Support the implementation of new technologies to enhance writing efficiency.
Project & Program Management
Assist in program-level management activities including:
Timeline development
Budget and forecast creation
Contract modification and scope control
Identify and resolve out-of-scope issues.
🧩 Education and Experience
|
Requirement |
Details |
|---|---|
|
Education |
Bachelor’s degree in a scientific discipline required; advanced degree preferred |
|
Experience |
Minimum 8+ years of relevant medical writing experience |
|
Industry Background |
Pharmaceutical or CRO industry preferred |
|
Certifications |
AMWA, EMWA, or RAC qualifications advantageous |
💡 Knowledge, Skills, and Abilities
Strong understanding of global and regional regulatory guidelines.
Excellent scientific interpretation, grammar, and editorial accuracy.
Expertise in preclinical, therapeutic, or regulatory documentation.
Advanced project management, problem-solving, and decision-making skills.
Strong negotiation and interpersonal communication abilities.
Skilled in document management systems and MS Office tools (Excel, Outlook, etc.).
Comfortable using technology to support writing efficiency.
Ability to multi-task, perform under stress, and adapt to changing conditions.
🏆 Behavioral Competencies
Acts with integrity and intensity.
Demonstrates leadership, collaboration, and ownership.
Excels in cross-functional teamwork and communication.
💰 Compensation & Benefits
Competitive salary and annual incentive bonus.
Comprehensive healthcare and wellness programs.
Flexible work culture promoting work-life balance.
Opportunities for career growth and development.
Inclusive and innovative work environment built on:
Integrity
Intensity
Innovation
Involvement
🌐 Why Join Thermo Fisher Scientific
Be part of a global team of 100,000+ professionals united by a mission to make the world healthier, cleaner, and safer. Collaborate with experts across research, clinical, and digital innovation to accelerate discovery and deliver impact.
#StartYourStory at Thermo Fisher Scientific — where science meets purpose and people thrive through collaboration.
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