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Principal Medical Writer

8+ years years
Not Disclosed
10 Aug. 29, 2025
Job Description
Job Type: Remote Education: Bachelor’s degree in a scientific discipline (required); Advanced degree (Master’s/PhD) Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Principal Medical Writer


Location

Remote – India

Job ID

R-01316074

Job Type

Full-time

Category

Clinical Research

Work Schedule

Other (Flexible as required)

Work Environment

Remote (Office setup)


Company Overview

Thermo Fisher Scientific is a global leader in science, innovation, and healthcare. Through our PPD® clinical research portfolio, we conduct trials in over 100 countries, supporting research, development, and the delivery of life-changing therapies.

Join us to make a global impact, enabling our customers to make the world healthier, cleaner, and safer.


Position Summary

We are expanding our Medical Writing FSP Team in India and seeking a Principal Medical Writer (PMW). This role is client-dedicated within the FSP (Functional Service Provider) model. Preferred candidates will have experience with Structured Content Authoring systems and AI-driven content automation.

As a PMW, you will lead the development of complex regulatory documents and mentor junior writers, ensuring timely and accurate completion aligned with industry standards and regulatory expectations.


Key Responsibilities

  • Lead the writing, editing, and quality review of complex clinical and regulatory documents.

  • Collaborate with cross-functional teams (clinical, regulatory, biostatistics, medical affairs) for input and approval.

  • Ensure compliance with applicable regulatory guidelines, internal standards, and best practices.

  • Provide strategic direction on content structure, flow, and presentation.

  • Mentor and oversee junior writers; provide quality oversight.

  • Manage multiple writing projects simultaneously with effective prioritization.

  • Stay updated on industry trends, evolving guidelines, and global regulatory changes.


Education & Experience

  • Bachelor’s degree in a scientific discipline (required); Advanced degree (Master’s/PhD) preferred.

  • 8+ years of experience in core regulatory medical writing roles.

  • Previous experience working in the pharmaceutical or CRO industry is required.

  • Proven experience managing and directing complex medical writing projects.

  • Strong background in Phase 3 CSRs and protocol development is essential.

  • Experience with EU CTR preferred.

  • Prior work with structured content management systems, AI tools, and Natural Language Generation (NLG) is a plus.


Knowledge, Skills & Abilities

  • Excellent organizational and program management skills.

  • Demonstrated leadership abilities to guide and mentor writing teams.

  • In-depth knowledge of regulatory guidelines and drug development processes.

  • Strong interpersonal and communication skills to collaborate with internal and external stakeholders.

  • Understanding of quality control processes and regulatory compliance.

  • Self-motivated, adaptable, and capable of making independent decisions.

  • Ability to manage multiple deadlines while ensuring quality and consistency.

  • Comfortable working independently and in collaborative settings.


What We Offer

  • Competitive salary and comprehensive benefits package.

  • Access to an award-winning learning and development program.

  • Flexible remote working culture with a focus on work-life balance.

  • A collaborative, globally connected team environment with local engagement.

  • Opportunities for career advancement and skill development.

  • A mission-driven workplace focused on innovation, integrity, and involvement.


About Us

At PPD clinical research services, part of Thermo Fisher Scientific, we are a team of 100,000+ professionals committed to improving global health through science. Our values—Integrity, Intensity, Innovation, and Involvement—guide everything we do.

Join us and #StartYourStory in an organization that values diverse experiences and empowers employees to grow, innovate, and make a difference.