Principal Medical Writer – Regulatory Medical Writing
Location: Remote, North Carolina, USA
Job Type: Full-time | Category: Clinical Research | Remote
Join Thermo Fisher Scientific and Shape the Future of Clinical Research
At Thermo Fisher Scientific, we empower innovation that transforms lives. Our Clinical Research Services (CRS) team, part of our PPD® portfolio, delivers high-quality scientific and regulatory expertise to advance life-changing therapies. Operating across 100+ countries, our team enables faster, safer drug development through laboratory, digital, and decentralized clinical trial services.
We are seeking a Principal Medical Writer to lead regulatory medical writing initiatives that ensure compliance, accuracy, and clarity across clinical trial documents and regulatory submissions. This is a fully remote opportunity for professionals based in the United States.
Your Role and Responsibilities:
As a Principal Medical Writer, you will lead complex regulatory writing projects, providing high-quality scientific content for global submissions. You will serve as a key contributor and mentor within the medical writing team. Responsibilities include:
Develop, review, and finalize regulatory documents including protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), INDs, and Marketing Applications (MAAs).
Summarize clinical data, interpret results, and ensure scientific accuracy and regulatory compliance.
Act as primary author or co-author for complex clinical and scientific documents, contributing to program-level submissions.
Provide mentorship and guidance to junior medical writers and program managers on best practices, document types, regulatory requirements, and authoring strategies.
Assist in program management, including timelines, budgets, forecasts, and contract modifications, resolving scope or resource challenges.
Collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, Biostatistics, and Data Management to ensure alignment and document quality.
Required Qualifications:
Bachelor’s degree in a scientific discipline; advanced degree (MS, PharmD, or PhD) preferred.
Minimum 8+ years of experience in regulatory medical writing within the pharmaceutical or CRO industry.
Proven expertise in managing and directing complex regulatory document projects.
Strong knowledge of global and regional regulatory document guidelines and submission requirements.
Advanced medical writing, data interpretation, editorial, and proofreading skills.
Excellent project management, problem-solving, negotiation, and communication skills.
Preferred Qualifications:
Experience with preclinical, therapeutic, or marketing application submissions.
Certification or membership with AMWA, EMWA, or RAC is advantageous.
Proficiency with document management systems, regulatory templates, and Microsoft Office Suite.
Ability to mentor teams and foster knowledge-sharing in a fast-paced, dynamic environment.
Why Thermo Fisher Scientific:
Competitive salary and annual incentive plan bonus
Comprehensive healthcare and wellness benefits
Flexible remote working culture supporting work-life balance
Career development, mentorship, and learning opportunities within a global organization
Inclusive, collaborative environment valuing diversity, integrity, and innovation
Experience Level: Senior / Principal – Minimum 8 years in regulatory medical writing, with leadership in complex clinical documentation and submission projects.
Apply Now to join a global leader in scientific innovation and make an impact on patient outcomes worldwide. Be part of a team that values integrity, intensity, involvement, and innovation while supporting the next generation of medical breakthroughs.
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