Principal Medical Writer (Regulatory) – Fully Remote, United States
Job Title: Principal Medical Writer (Regulatory Medical Writing)
Location: Remote, United States (North Carolina preferred but fully remote options available)
Job Type: Full-Time
Category: Clinical Research
Experience Required: Minimum 8+ years of relevant Regulatory Medical Writing experience
Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Overview
Thermo Fisher Scientific is a global leader in scientific innovation, supporting the development of life-changing therapies and advancing modern clinical research. With trials conducted in more than 100 countries, our PPD® clinical research portfolio drives high-quality scientific outcomes across laboratory, digital, and decentralized trial models.
We are expanding our Medical Writing division and seeking a Principal Medical Writer to lead the development of regulatory documentation for global drug development programs.
Role Summary
The Principal Medical Writer is responsible for delivering high-quality Regulatory Medical Writing documents, including clinical study reports (CSR), study protocols, Investigator’s Brochures, and components of regulatory submissions such as INDs and MAAs. This position requires strong leadership, scientific expertise, and the ability to manage complex writing projects with precision and compliance.
Key Responsibilities
Produce high-quality medical and scientific documents from initial planning through final delivery to internal and external stakeholders.
Serve as the primary author for clinical study reports, protocols, and other regulatory documents.
Lead the creation, review, and editing of complex program-level documents including IBs, INDs, and marketing application components.
Provide mentorship and training to junior writers and cross-functional team members on writing standards, document strategy, and regulatory expectations.
Support program management activities including timeline development, forecasting, budgeting, and scope change identification.
Ensure alignment with global, regional, and national regulatory guidelines.
Qualifications
Education
Bachelor’s degree in a scientific discipline required.
Advanced degree (Master’s, PhD, PharmD, MD) preferred.
Experience
Minimum 8+ years of Medical Writing experience in regulatory or clinical research environments.
Proven experience managing complex regulatory writing projects.
Prior work in the pharmaceutical, biotech, or CRO industry strongly preferred.
Additional certifications (AMWA, EMWA, RAC) are an advantage.
Knowledge & Skills
Deep understanding of global regulatory requirements and document development standards.
Excellent data interpretation, scientific writing, editing, and proofreading skills.
Strong project management skills with the ability to manage multiple priorities.
Effective interpersonal, negotiation, and decision-making capabilities.
Proficiency with document management systems, writing templates, and standard software tools (Word, Excel, Outlook).
Strong presentation and communication skills.
Work Environment
Standard full-time schedule (Monday–Friday).
Fully remote, office-based digital work environment.
Why Join Thermo Fisher Scientific?
Thermo Fisher Scientific offers a collaborative and innovation-driven culture focused on scientific excellence and patient impact. Employees benefit from:
Competitive compensation and annual incentive bonuses
Comprehensive healthcare and wellness benefits
Flexible working culture supporting work-life balance
Clear career development pathways and continuous professional growth
A global yet inclusive workplace built on Integrity, Intensity, Innovation, and Involvement
As part of a 100,000+ global workforce, you will contribute to advancing research, solving complex scientific challenges, and improving global health outcomes.
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