FSP Medical Writer – Clinical & Regulatory Writing (Pharma / CRO Industry)
Thermo Fisher Scientific – PPD Clinical Research Services
Job Overview
Thermo Fisher Scientific is seeking a skilled FSP Medical Writer to join its expanding Functional Service Provider (FSP) team in India. This role focuses on delivering high-quality clinical and regulatory documentation for global pharmaceutical and clinical research clients.
The position involves working within structured content authoring environments and supporting AI-driven and automated medical writing processes to improve efficiency, accuracy, and regulatory compliance across clinical development programs.
Experience Required
Minimum 2+ years of experience in medical writing within the pharmaceutical, biotechnology, or CRO industry.
Educational Qualification
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or related scientific discipline (mandatory)
Advanced degree (Master’s or PhD) preferred
Key Responsibilities
Develop, write, and edit clinical and regulatory documents including:
Clinical Study Reports (CSRs)
Clinical Study Protocols
Investigator Brochures (IBs)
Regulatory submission documents
Ensure all documents meet global regulatory guidelines, client standards, and internal quality requirements
Collaborate with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and medical affairs
Gather, interpret, and validate scientific data for accurate documentation
Review and provide feedback on documents prepared by other medical writers
Ensure consistency, clarity, and scientific accuracy across all deliverables
Manage project timelines and ensure on-time delivery of assigned writing tasks
Stay updated with evolving regulatory guidelines, industry standards, and clinical development practices
Support structured content authoring systems and AI-enabled medical writing tools
Required Skills & Competencies
Strong experience in clinical and regulatory medical writing
Solid understanding of drug development lifecycle and clinical research processes
Knowledge of global regulatory guidelines (ICH, FDA, EMA, etc.)
Excellent scientific writing, editing, and proofreading skills
Strong attention to detail and ability to ensure document accuracy and compliance
Good project management and organizational skills
Ability to work independently as well as in cross-functional teams
Strong communication and stakeholder management skills
Familiarity with structured content management systems is an advantage
Exposure to AI-driven or automated content generation tools is preferred
Preferred Skills
Experience in safety writing (e.g., DSUR, safety narratives)
Exposure to CRO or large pharmaceutical environments
Familiarity with Natural Language Generation (NLG) tools
Experience working in global, multi-region clinical research teams
Mentoring or leadership experience in medical writing teams
Job Type & Work Model
Full-time | Permanent | Standard Office Working Hours (Monday to Friday)
Work Environment
Office-based role with collaboration across global clinical and regulatory teams.
Industry Domain
Clinical Research | Pharmaceutical Industry | CRO Services | Regulatory Writing | Medical Affairs
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
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Digha | Kolkata | Mukundapur |Goa :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
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Copenhagen | Denmark |Europe :
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Swords |Republic of China :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Tallinn |Hà Nội :
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Ciudad de México | New Mexico |Dubai :
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Riyadh | Jeddah | King Abdullah Economic City | Khulais | Najran | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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