Job Title:
Principal Medical Writer (Regulatory Medical Writing)
Location:
Remote — North Carolina, United States
Job ID:
R-01332392
Job Type:
Full-Time
Category:
Clinical Research
Work Arrangement:
Fully Remote
Work Schedule:
Standard (Monday–Friday)
Environment:
Home/Office-Based
About the Company
Thermo Fisher Scientific, through its PPD® Clinical Research Services, is a global leader in bringing innovative therapies to market.
With clinical trials conducted across 100+ countries, our mission is to enable customers to make the world healthier, cleaner, and safer.
We empower employees with the resources, support, and opportunities needed to advance science and make a meaningful difference in global health outcomes.
Position Summary
The Principal Medical Writer (Regulatory MW) is responsible for authoring, reviewing, and managing the preparation of high-quality regulatory and clinical documents that support drug development and approval.
This role involves working independently on complex projects, mentoring junior writers, and ensuring compliance with global regulatory standards. The ideal candidate will demonstrate scientific expertise, exceptional writing precision, and strong project leadership.
Key Responsibilities
Medical and Scientific Writing
Prepare and deliver high-quality regulatory and clinical documents, including:
Clinical Study Reports (CSRs)
Study Protocols
Investigator’s Brochures (IBs)
Investigational New Drug (IND) applications
Marketing Authorization Applications (MAAs)
Summarize and interpret clinical study data accurately for submission-ready documentation.
Research, write, and edit complex scientific documents across multiple therapeutic and regulatory domains.
Leadership and Mentorship
Serve as lead author and subject-matter expert for multiple programs or compounds.
Provide training and mentorship to junior writers and project managers on:
Document development strategy
Regulatory guidelines
Industry best practices
Use of writing tools and document management systems
Project and Quality Management
Ensure documents meet global, regional, and national regulatory guidelines (ICH, FDA, EMA, etc.).
Manage project timelines, budgets, and deliverables, ensuring adherence to scope and quality expectations.
Support program management activities such as forecasting, contract modifications, and client communication.
Identify and resolve out-of-scope activities or project risks proactively.
Education and Qualifications
Required Education
Bachelor’s degree in a scientific discipline (e.g., Life Sciences, Pharmacy, Medicine).
Preferred Education
Advanced degree (Master’s, PhD, or PharmD) preferred.
Professional certification (e.g., AMWA, EMWA, RAC) advantageous.
Experience
8+ years of relevant experience in medical writing, preferably in regulatory submissions.
Proven experience managing and leading complex global writing projects.
Prior experience in the pharmaceutical or CRO industry strongly preferred.
Knowledge, Skills, and Abilities
Deep knowledge of global regulatory writing standards and documentation guidelines.
Exceptional ability to interpret and synthesize clinical and statistical data.
Strong editorial, grammatical, and proofreading skills.
Expertise in project management, communication, and stakeholder collaboration.
Proficiency in Microsoft Office Suite, document management systems, and authoring tools.
Ability to multi-task and perform under pressure while maintaining accuracy and timeliness.
Excellent negotiation, problem-solving, and decision-making capabilities.
Core Competencies
Integrity: Upholds ethical standards and transparency in data presentation.
Intensity: Demonstrates commitment to excellence and results-driven performance.
Innovation: Adopts new technologies and methodologies to enhance writing efficiency.
Involvement: Collaborates effectively within cross-functional global teams.
Compensation and Benefits
Rewards and Recognition
Competitive base salary
Annual incentive plan bonus
Comprehensive health and wellness coverage
Benefits Include
Medical, dental, and vision insurance
Flexible working culture promoting work-life balance
Paid time off, holidays, and parental leave
Career development and training opportunities
Retirement plans and employee stock purchase options
Why Join Thermo Fisher Scientific?
At Thermo Fisher Scientific, you will be part of a global team of 100,000+ professionals united by a shared mission to advance science and improve lives.
Our 4i Values — Integrity, Intensity, Innovation, and Involvement — drive everything we do.
Join us to #StartYourStory and make a lasting impact through scientific excellence and meaningful contribution to global health.
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