Job Title: Principal Medical Writer
Location: Remote, India
Company: Thermo Fisher Scientific
Employment Type: Full-time
Salary: ₹18 LPA – ₹32 LPA (Estimated)
Job Description
Thermo Fisher Scientific is seeking an experienced Principal Medical Writer to join its Clinical Research Services team. In this role, you will be responsible for delivering high-quality medical and scientific documents from planning and coordination through final submission to internal and external stakeholders.
As a senior member of the medical writing team, you will lead complex document development, provide strategic guidance on regulatory documentation, mentor junior writers, and collaborate with global teams to support efficient clinical research and regulatory submissions.
Key Responsibilities
Research, write, and edit clinical and regulatory documents including clinical study reports and study protocols.
Author and contribute to complex scientific and regulatory documents such as Investigator Brochures (IBs), INDs, and MAAs.
Provide senior-level review of routine and complex documents to ensure accuracy, consistency, and compliance.
Mentor and train junior medical writers and program managers on document preparation, regulatory requirements, and writing standards.
Ensure compliance with quality standards, regulatory guidelines, and internal processes.
Lead process improvement initiatives and develop best practices for document development.
Serve as backup program manager, supporting timelines, budgets, and project planning when needed.
Represent the department in project launch meetings, review meetings, and cross-functional discussions.
Required Qualifications
Bachelor’s degree in a scientific discipline or equivalent qualification.
Advanced degree preferred (e.g., MSc, PhD, PharmD, MD).
8+ years of experience in medical writing or related roles.
Experience managing complex medical writing projects.
Experience in the pharmaceutical, biotechnology, or CRO industry preferred.
Certifications such as AMWA, EMWA, or RAC are advantageous.
Skills & Competencies
Strong knowledge of global and regional regulatory document development guidelines.
Expertise in clinical, therapeutic, regulatory, or scientific communications documentation.
Excellent data interpretation, medical writing, editing, and proofreading skills.
Advanced project management and organizational abilities.
Strong communication, presentation, and negotiation skills.
Ability to work independently and mentor junior team members.
Strong problem-solving skills and decision-making ability.
About the Company
Thermo Fisher Scientific is a global leader in scientific services and clinical research. Through its PPD® clinical research portfolio, the company supports pharmaceutical and biotechnology organizations worldwide in developing innovative medicines and bringing life-changing treatments to patients.
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