Position: Senior Medical Writer
Location: Remote, India
Job ID: R-01332283
Job Type: Full-time
Category: Clinical Research
Work Schedule: Standard (Mon-Fri)
Environment: Office / Remote
The Clinical Research team at PPD® is a leading global CRO delivering high-quality scientific and clinical expertise to accelerate drug development for challenging health conditions. The team drives excellence in clinical study documentation and regulatory submissions.
Provide high-quality medical and scientific writing from planning to final document delivery. Demonstrates subject matter and therapeutic area expertise. Collaborates with internal and external clients to ensure effective and efficient communication. May assist program managers.
1. Document Creation & Review
Serve as primary author on routine documents, including:
Clinical Study Reports (CSRs)
Study Protocols
Investigator Brochures (IBs)
INDs and MAAs (complex documents as needed)
Summarize clinical study data.
Review documents prepared by junior writers for quality and compliance.
Provide training and mentorship for junior writers on document preparation, software use, regulatory requirements, and therapeutic area knowledge.
2. Compliance & Best Practices
Ensure all documents comply with quality standards and regulatory requirements.
Independently develop best practices, methods, and techniques for document preparation, including client-specific processes.
3. Project Support & Program Management
Assist in program management activities:
Develop timelines, budgets, forecasts, and contract modifications
Identify and resolve out-of-scope activities
Represent the department at project launch, review, and team meetings.
Education & Experience
Bachelor’s degree in a scientific discipline or equivalent; advanced degree preferred.
Minimum 5+ years of relevant medical writing experience.
Pharmaceutical or CRO experience preferred.
Additional certifications (AMWA, EMWA, RAC) advantageous.
Knowledge, Skills & Abilities
Excellent medical writing, data interpretation, grammatical, editorial, and proofreading skills.
Strong project management capabilities.
Excellent interpersonal, problem-solving, negotiation, oral and written communication, and presentation skills.
Significant knowledge of global, regional, and national document development guidelines.
In-depth knowledge in specialty areas such as preclinical, therapeutic, regulatory submissions, or communications.
Strong judgment and decision-making skills.
Proficient with computer applications, document management systems, and client templates (Excel, Outlook, etc.).
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
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China | Quarry Bay |Liaoning :
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Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
Montreal |Brussels :
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Zaventem |South America :
Argentina | Peru |Brazil :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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King Abdullah Economic City | Khulais | Riyadh | Rabigh | Najran | Jeddah |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
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