Principal Medical Writer
Remote – India
R-01316074
Full-time
Clinical Research
Other (Flexible as required)
Remote (Office setup)
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.
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.
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.
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.
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.
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.
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.
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