Principal Medical Writer – Clinical Research (Remote, India)
Category: Clinical Research / Medical Writing
Job Type: Full-Time
Work Mode: Fully Remote
Location: India (Remote)
Job ID: R-01332281
Job Overview
Thermo Fisher Scientific is seeking an accomplished Principal Medical Writer to join its global Clinical Research Services team supporting the PPD® clinical research portfolio. This senior-level, fully remote role is designed for experienced medical writing professionals who bring deep scientific expertise, leadership capability, and strategic oversight to complex clinical development and regulatory documentation.
As a Principal Medical Writer, you will lead the planning, development, review, and delivery of high-quality clinical and regulatory documents for global pharmaceutical and biotechnology clients, while mentoring junior writers and contributing to operational excellence.
Role Purpose
The Principal Medical Writer is responsible for delivering accurate, compliant, and strategically aligned medical and scientific documents from concept through final submission. Acting as a lead author and subject matter expert, the role includes document strategy development, senior-level review, cross-functional collaboration, and oversight of complex writing programs. The position also supports program management activities and continuous process improvement initiatives.
Key Responsibilities
Lead the research, writing, and editing of complex clinical documents including Clinical Study Reports (CSRs), study protocols, Investigator’s Brochures (IBs), INDs, MAAs, and other regulatory submissions
Serve as primary author or lead reviewer for high-impact clinical and program-level documents
Provide senior-level quality review of routine and complex documents to ensure accuracy, consistency, and regulatory compliance
Mentor, train, and guide junior medical writers and program managers on document standards, regulatory requirements, and therapeutic area knowledge
Advise internal and external stakeholders on document development strategies, industry best practices, and regulatory expectations
Ensure adherence to global quality processes, SOPs, and client-specific requirements
Lead or contribute to process improvement initiatives and development of best practices
Develop, monitor, and manage performance metrics for assigned projects
Act as backup Program Manager, supporting timeline planning, budget oversight, forecasting, and change management
Support business development activities including proposal writing, client presentations, and bid defense meetings
Represent the medical writing function in project initiation, review, and cross-functional team meetings
Required Education & Experience
Bachelor’s degree in a scientific discipline or equivalent qualification
Advanced degree (MS, PhD, PharmD, or MD) strongly preferred
Minimum 8+ years of experience in medical writing within the pharmaceutical, biotechnology, or CRO industry
Proven experience managing and directing complex medical writing projects
Hands-on experience with global regulatory documents and submissions
Professional certifications such as AMWA, EMWA, or RAC are an advantage
Core Skills & Competencies
In-depth knowledge of global, regional, and country-specific regulatory and document development guidelines
Expertise in one or more specialty areas including preclinical, clinical, therapeutic, regulatory, or submissions writing
Advanced data interpretation, scientific writing, editing, and proofreading skills
Strong project management, planning, and organizational abilities
Excellent interpersonal, negotiation, and stakeholder management skills
High level of independence, sound judgment, and problem-solving capability
Proven ability to mentor, lead, and develop junior team members
Strong oral, written, and presentation communication skills
Why Join Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in serving science, enabling customers to make the world healthier, cleaner, and safer. Through the PPD® clinical research business, employees contribute to innovative global drug development programs while benefiting from flexible work arrangements, continuous learning opportunities, and long-term career growth.
Equal Opportunity Statement
Thermo Fisher Scientific is an equal opportunity employer and is committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, ethnicity, gender, sexual orientation, disability, veteran status, or any other protected characteristic.
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