Medical Writer – Regulatory and Clinical Documentation
Location: Mumbai, Pune, Bangalore, Hyderabad, India
Department: Business Process Services / Medical Writing
Employment Type: Full-Time
Experience Required: 3–12 years (overall experience range: 2–7 years considered)
Application Deadline: 30 April 2026
Education Required: Life Sciences Graduate (B.Pharm, B.Sc, M.Pharm, M.Sc or equivalent)
Job Overview
A leading global organization is seeking experienced Medical Writers to support clinical and regulatory documentation for pharmaceutical and life sciences projects. This role focuses on the preparation, review, and quality assurance of clinical documents for regulatory submissions while ensuring scientific accuracy, compliance with global regulatory standards, and adherence to internal standard operating procedures. The position requires strong collaboration with cross-functional study teams and expertise in clinical research documentation.
Key Responsibilities
Clinical and Regulatory Documentation
Perform quality checks of clinical documents prepared for regulatory submissions, including study protocols, clinical study pharmacology reports, clinical study reports, patient narratives, clinical summaries of safety, clinical summaries of efficacy, and Common Technical Document (CTD) modules.
Prepare and develop clinical and regulatory documents in compliance with organizational SOPs, document standards, and regulatory guidance.
Project Coordination and Stakeholder Collaboration
Initiate and participate in start-up meetings with study teams for clinical document development.
Collaborate with internal and external stakeholders to ensure accurate and timely development of clinical documentation.
Communicate and manage project timelines with study teams to ensure timely deliverables.
Scientific Review and Content Management
Review statistical analysis plans, tables, figures, and listings as required.
Ensure consistency, scientific accuracy, and clarity across regulatory and clinical documents.
Maintain uniformity in scientific content and ensure compliance with global regulatory requirements.
Quality Assurance and Compliance
Ensure all documentation meets regulatory standards and submission requirements.
Maintain document quality, accuracy, and consistency throughout the medical writing process.
Education Requirements
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related disciplines such as B.Pharm, B.Sc, M.Pharm, or M.Sc.
Experience Requirements
3–12 years of experience in medical writing, clinical documentation, or regulatory writing within the pharmaceutical or healthcare industry.
Practical experience in preparing or reviewing regulatory submission documents is preferred.
Understanding of clinical research processes and regulatory documentation standards.
Required Skills and Competencies
Strong knowledge of clinical research and regulatory submission documentation.
Excellent scientific writing and documentation skills.
Strong attention to detail and quality assurance capabilities.
Ability to work collaboratively with cross-functional teams.
Effective communication and project management skills.
Expertise in life sciences domain and clinical documentation standards.
Gujarat :
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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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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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Dún Laoghaire |Galway :
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China | Quarry Bay |Liaoning :
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Shanghai Shi |Hubei :
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Netherlands |Remote Australia :
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Queensland |Melbourne :
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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 :
Montreal |Brussels :
Brussels |Antwerp :
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Argentina | Peru |Brazil :
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Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
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Saitama | Japan |Tokyo :
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Buenos Aires |Republic of Egypt :
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New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Najran | Riyadh | King Abdullah Economic City | Khulais | Jeddah | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
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