Principal Medical Writer
Location: Remote, India
Job ID: R-01332281
Employment Type: Full-Time
Category: Medical Writing / Clinical Documentation
Work Mode: Fully Remote
About the Opportunity
Join one of the world’s leading Contract Research Organizations (CROs) supporting global clinical development through the PPD clinical research portfolio of Thermo Fisher Scientific. As a Principal Medical Writer, you will play a key role in developing high-quality clinical and scientific documents that support regulatory submissions, clinical studies and global drug development programs. This position offers the opportunity to lead writing projects, mentor junior writers and collaborate with cross-functional teams across diverse therapeutic areas.
Role Overview
The Principal Medical Writer is responsible for authoring, reviewing and delivering complex clinical and regulatory documents. This role manages end-to-end document development, ensures adherence to regulatory standards and supports strategic planning for document execution. As a senior member of the team, you will also contribute to process improvements, provide expert guidance on document development and may serve as a backup program manager for large-scale projects.
Key Responsibilities
Author, edit and finalize clinical documents including protocols, clinical study reports, investigator brochures, IND sections and marketing authorization documents.
Lead development of complex clinical and scientific documents at program level with minimal supervision.
Provide senior-level review and quality oversight of clinical and regulatory documents.
Mentor and train junior writers and program managers on document development, regulatory guidelines, therapeutic knowledge and software tools.
Ensure all assigned documents comply with organizational quality standards, regulatory guidelines and client-specific requirements.
Develop best practices and contribute to continuous process improvement across teams.
Support project planning, tracking and timeline management while identifying out-of-scope activities.
Serve as backup program manager, contribute to timelines, budgets and forecasts, and participate in client presentations or bid defense meetings.
Represent the medical writing function in cross-functional meetings and project kick-offs.
Required Education and Experience
Bachelor’s degree in a scientific discipline is required; advanced degree strongly preferred.
Minimum 8 years of professional medical writing experience in the pharmaceutical, biotechnology or CRO industry.
Proven experience managing and delivering complex medical writing projects.
Additional certifications such as AMWA, EMWA or RAC are advantageous.
Equivalent combinations of education, training and experience may be considered.
Skills and Competencies
Strong knowledge of global and regional regulatory guidelines for document development.
Expertise in one or more areas: preclinical, regulatory submissions, clinical development or scientific communications.
Exceptional medical writing, scientific interpretation, editorial and proofreading skills.
Advanced project management and organizational abilities.
Strong interpersonal, written and verbal communication skills.
Ability to negotiate, influence and collaborate effectively across departments.
Demonstrated leadership with ability to mentor and guide junior staff.
High level of independence, sound judgment and problem-solving capabilities.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Rangpo |India :
Siliguri |Illinois :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
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Canada |Quebec :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Auckland |New Zealand :
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Zagreb |Estonia :
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Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
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