Document Review Specialist II (Medical Writing) – Remote, India
Job Type: Full-Time
Work Model: Fully Remote
Category: Clinical Research / Medical Writing
Location: India
About the Role
We are seeking a Document Review Specialist II to support our global Clinical Research operations. In this role, you will review, validate, and enhance high-quality scientific and regulatory documents that support global drug development. As part of a leading international Contract Research Organization (CRO), you will contribute to ensuring accuracy, compliance, and clarity across essential clinical and regulatory documentation.
This position plays a crucial role in maintaining the scientific integrity and regulatory readiness of documents that support complex clinical programs.
Key Responsibilities
Review a wide range of technical and scientific documents, including:
Regulatory submissions
Integrated Clinical Study Reports (CSRs)
Serious Adverse Event (SAE) narratives
Clinical study protocols
Investigator brochures (IBs)
Publications and other regulatory materials
Validate data accuracy by cross-checking tables and content against source documents.
Ensure compliance with current regulatory standards and industry guidelines (ICH, GCP, FDA, EMA, etc.).
Edit documents for clarity, consistency, scientific logic, and grammatical correctness.
Modify review schedules to manage priority or urgent document requests.
Collaborate with authors to resolve inconsistencies and improve document quality.
Apply up-to-date knowledge of templates, industry standards, and medical writing best practices.
Provide guidance to teams outside the quality review group regarding review processes.
Qualifications & Experience
Education
Bachelor’s degree or equivalent qualification in Life Sciences, Pharmacy, Biotechnology, Medicine, or related fields.
Experience Required
Minimum 5+ years of relevant experience in medical writing, document quality review, or regulatory writing.
Proven expertise in reviewing CSRs, Protocols, ICFs, IBs, IND Modules, and other regulatory documents.
Skills & Competencies
Strong understanding of medical writing methodologies, data validation techniques, and regulatory documentation requirements.
Excellent knowledge of medical terminology, statistical concepts, ICH-GCP guidelines, and global regulatory expectations.
High level of attention to detail with the ability to understand both technical depth and overall document intent.
Strong analytical, organizational, and planning skills.
Exceptional written and verbal communication skills.
Ability to work independently and within cross-functional, geographically dispersed teams.
Proficiency in document management systems and advanced computer literacy.
Ability to work under pressure while maintaining quality and accuracy.
Work Schedule
Standard Monday–Friday business hours.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Rangpo |India :
Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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Saarbrucken |Switzerland :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
Ballydine |Cork :
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Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
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 :
Australia | North York | Mississauga | Richmond Hill | Uxbridge | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |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 :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Brentwood |Bucharest :
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Buenos Aires |Republic of Egypt :
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Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
Khulais | Riyadh | King Abdullah Economic City | Jeddah | Najran | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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