Principal / Senior Medical Writer – Clinical Trials
Company: Thermo Fisher Scientific – PPD Clinical Research Services
Location: Mumbai, Maharashtra, India (Remote within APAC Possible)
Job Type: Full-Time
Category: Clinical Research / Medical Writing
Experience Required: 8+ Years in Regulatory Medical Writing
Job Overview
Thermo Fisher Scientific’s PPD Clinical Research Services is expanding its Medical Writing FSP team in APAC. We are seeking a Principal or Senior Medical Writer to provide high-quality regulatory and scientific writing support for clinical trials across therapeutic areas, including Immunology, Oncology, and Vaccines.
This role involves authoring, reviewing, and managing complex regulatory documents, mentoring junior writers, and providing strategic input on document development, regulatory compliance, and best practices. The ideal candidate will thrive in a fast-paced, global clinical research environment, delivering accuracy, clarity, and compliance across all documentation.
Key Responsibilities
Medical Writing & Regulatory Documentation
Author and review clinical study reports (CSRs), protocols, investigator brochures (IBs), informed consent documents (ICDs), case report forms (CRFs), and patient diaries
Contribute to regulatory submission documents including INDs, MAAs, and associated global submissions
Provide senior-level review of routine and complex documents ensuring adherence to global, regional, and client-specific standards
Project & Team Leadership
Lead complex medical writing projects and ensure timely delivery to internal and external stakeholders
Mentor and guide junior writers on document preparation, regulatory requirements, therapeutic area knowledge, and software tools
Act as subject matter expert for document development strategy, regulatory compliance, and process optimization
Collaboration & Communication
Work closely with internal teams including Clinical Operations, Biostatistics, Medical Affairs, and Regulatory Affairs
Liaise with external stakeholders, including investigators, key opinion leaders (KOLs), and medical associations
Support project management activities such as timelines, budgets, forecasts, and client proposal reviews
Quality & Process Improvement
Ensure compliance with ICH-GCP, regional regulatory requirements, and internal SOPs
Develop and implement best practices, training, and quality metrics for medical writing projects
Contribute to continuous improvement initiatives to optimize document quality and operational efficiency
Required Qualifications
Educational Background
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field; Advanced degree preferred
Experience
8+ years of regulatory medical writing experience in pharmaceutical, biotechnology, or CRO environments
Proven experience in authoring and reviewing CSR, Protocol, ICF, IB, and other regulatory documents
Experience managing complex medical writing projects and teams
Familiarity with regulatory submissions and guidelines advantageous
Skills & Competencies
Strong knowledge of global and regional regulatory requirements for clinical documents
Expertise in data interpretation, scientific writing, editorial standards, and proofreading
Excellent project management, organizational, and communication skills
Ability to mentor, lead, and influence junior team members
Familiarity with AMWA, EMWA, RAC, ICH-GCP, and therapeutic area standards is a plus
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
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Sarajevo |Singapore :
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