Senior Medical Writer – Remote (India)
Job Type: Full-Time
Category: Clinical Research
Work Model: Fully Remote
Location: India
About the Role
We are seeking a highly skilled Senior Medical Writer to deliver high-quality scientific and clinical documentation that supports global clinical research programs. This role contributes to critical regulatory and clinical submission activities across multiple therapeutic areas and plays a vital part in ensuring clarity, accuracy, and compliance in all written content. You will collaborate with internal teams, external clients, and cross-functional stakeholders to drive operational excellence.
This opportunity is ideal for experienced medical writers looking to contribute to a leading global Contract Research Organization (CRO) with an extensive PPD® clinical research portfolio.
Key Responsibilities
Serve as the primary author for clinical study reports, study protocols, and data summaries for clinical trials.
Research, write, and edit complex scientific and regulatory documents including Investigator’s Brochures (IBs), Investigational New Drug Applications (INDs), and Marketing Authorization Applications (MAAs).
Review and provide feedback on documents authored by junior writers; offer ongoing training and mentorship on writing standards, regulatory guidelines, software usage, and document development.
Ensure all documents meet quality standards and comply with regulatory, client-specific, and internal requirements.
Contribute to the development of best practices, templates, and standardized processes for medical writing operations.
Support program management activities such as timeline planning, budgeting, forecasting, and identifying out-of-scope tasks.
Represent the medical writing function in study start-up meetings, project review meetings, and client discussions.
Education Requirements
Bachelor’s degree in a scientific discipline is required.
Advanced degree (Master’s or PhD) preferred.
Experience Required
Minimum 5+ years of medical writing experience, preferably within the pharmaceutical or CRO environment.
Experience with regulatory, clinical, and program-level document development is essential.
Certifications such as AMWA, EMWA, or RAC are advantageous but not mandatory.
Key Skills & Competencies
Strong proficiency in medical and scientific writing, including grammar, scientific communication, and editorial accuracy.
Excellent data interpretation skills and ability to translate complex scientific information into clear and concise documentation.
Strong project management capabilities with proven ability to handle multiple assignments and meet strict timelines.
Effective interpersonal skills, including problem-solving, negotiation, and collaboration with cross-functional teams.
Solid understanding of global and regional regulatory guidelines for clinical and regulatory document development.
In-depth knowledge of specialized areas such as regulatory submissions, therapeutic domains, or scientific communications.
Proficiency in document management systems, MS Office (Excel, Outlook), and client-specific templates.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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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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Germany | GErmany |Lower Saxony :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Donegal |Meath :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Leiden |Netherlands :
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 :
Mississauga | Uxbridge | Richmond Hill | Australia | North York | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
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 :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Ciudad de México | New Mexico |Dubai :
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Rabigh | Jeddah | King Abdullah Economic City | Khulais | Najran | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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