Principal Medical Writer – Regulatory
Location: Remote, North Carolina, USA
Job Type: Full-Time, Fully Remote
Category: Clinical Research / Medical Writing
Job ID: R-01332392
About the Role
Thermo Fisher Scientific is seeking an experienced Principal Medical Writer to join our growing Clinical Research Services team. This role is fully remote in the United States and offers the opportunity to lead high-impact regulatory medical writing projects for global clinical research initiatives. You will be responsible for creating high-quality regulatory documents that support the development and approval of life-changing therapies, ensuring compliance with global regulatory standards.
Key Responsibilities
Lead the preparation, review, and delivery of regulatory medical writing documents, including:
Clinical Study Reports (CSRs)
Study Protocols
Investigator Brochures (IBs)
Marketing Applications and regulatory submissions (INDs, MAAs)
Provide scientific and medical writing expertise, ensuring accuracy, clarity, and compliance with global, regional, and national regulatory requirements.
Mentor and provide guidance to junior medical writers and project teams on document preparation, regulatory expectations, and best practices.
Support program management activities, including timelines, budgets, and resource planning for regulatory writing projects.
Collaborate with cross-functional teams, including clinical operations, biostatistics, regulatory affairs, and project management, to ensure high-quality deliverables.
Identify, assess, and resolve out-of-scope or complex writing challenges to maintain project quality and efficiency.
Experience Required
Minimum of 8+ years of experience in regulatory medical writing within the pharmaceutical, biotechnology, or CRO industry.
Proven track record in managing and delivering complex regulatory writing projects.
Experience with global regulatory submissions and understanding of ICH, FDA, EMA, and other regional guidelines.
Previous leadership or mentorship experience in medical writing is preferred.
Educational Qualifications
Bachelor’s degree in a scientific discipline is required.
Advanced degree (MSc, PharmD, MD, PhD) preferred.
Additional professional certifications in medical writing (AMWA, EMWA, RAC) are advantageous.
Key Skills & Competencies
Expertise in regulatory medical writing for clinical development programs.
Strong data interpretation and scientific communication skills.
Knowledge of preclinical, clinical, therapeutic areas, and regulatory frameworks.
Proficiency in client templates, document management systems, and Microsoft Office Suite.
Excellent project management, problem-solving, and negotiation skills.
Ability to multitask and perform under tight deadlines in a fast-paced, global environment.
Exceptional oral and written communication skills with strong attention to detail.
Why Join Thermo Fisher Scientific
Work with a leading global CRO on innovative clinical research programs impacting health outcomes worldwide.
Fully remote role with flexible work culture and global collaboration.
Competitive salary, annual incentive plans, healthcare coverage, and a comprehensive benefits package.
Opportunities for career growth, mentorship, and professional development in a dynamic, collaborative environment.
Join a mission-driven organization committed to making the world healthier, cleaner, and safer.
Who Should Apply
This role is ideal for senior medical writers with extensive regulatory writing experience, strong leadership capabilities, and a passion for high-quality clinical research documentation. If you thrive in a fast-paced, global environment and want to contribute to life-changing therapies, this position offers a unique opportunity to advance your career.
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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