Senior Medical Writer – Clinical Research (Fully Remote)
Location: Remote, India
Job ID: R-01332283
Employment Type: Full-Time
Industry: Clinical Research / Medical Writing / CRO
Work Schedule: Monday to Friday (Standard Business Hours)
Work Model: Fully Remote
Experience Required: Minimum 5+ Years in Medical Writing
ThePharmaDaily.com is featuring a senior-level opportunity for a Senior Medical Writer within a leading global Contract Research Organization (CRO) supporting clinical research services. This role is part of a high-performing clinical research portfolio focused on accelerating drug development and bringing innovative therapies to market.
This position is ideal for experienced medical writing professionals with strong regulatory and clinical documentation expertise who are seeking a fully remote opportunity in India.
Role Overview
The Senior Medical Writer is responsible for delivering high-quality medical and scientific documents across the clinical development lifecycle. The role involves planning, drafting, reviewing, and finalizing regulatory and clinical documents for internal and external stakeholders, ensuring scientific accuracy, regulatory compliance, and operational excellence.
The position requires therapeutic area expertise, strong project management skills, and the ability to collaborate with cross-functional global teams.
Key Responsibilities
Serve as primary author for clinical study reports (CSRs), study protocols, and data summaries
Research, write, and edit complex regulatory documents such as Investigator’s Brochures (IBs), INDs, and MAAs
Interpret and summarize clinical data accurately and clearly
Review and provide quality oversight for documents prepared by junior medical writers
Mentor and train junior team members on document preparation, regulatory standards, and writing best practices
Ensure compliance with global regulatory guidelines and internal quality standards
Develop and implement best practices for document development and client-specific processes
Support program management activities including timelines, forecasts, budgets, and scope management
Represent the department in project launch and review meetings
Identify and resolve out-of-scope activities while maintaining delivery timelines
Required Qualifications
Bachelor’s degree in a scientific discipline or equivalent qualification
Advanced degree (Master’s or PhD) preferred
Minimum 5+ years of experience in medical writing within the pharmaceutical or CRO industry
Demonstrated experience drafting CSRs, protocols, IBs, INDs, MAAs, and other regulatory documents
Strong understanding of global, regional, and national regulatory submission guidelines
Excellent data interpretation, scientific writing, grammar, editing, and proofreading skills
Strong project management and organizational abilities
Excellent verbal and written communication skills with presentation capabilities
Proficiency in document management systems and Microsoft Office tools (Excel, Outlook, etc.)
Ability to work independently in a fully remote, deadline-driven environment
Preferred Qualifications
Experience in therapeutic area specialization (e.g., preclinical, regulatory submissions, communications)
Certifications in medical writing or regulatory affairs (AMWA, EMWA, RAC) are advantageous
Experience managing document templates and client-specific formatting requirements
Strong negotiation and problem-solving skills
Work Environment
Fully remote role based in India
Standard Monday–Friday schedule
Collaborative engagement with global clinical and regulatory teams
This opportunity is ideal for senior medical writing professionals seeking career advancement in global clinical research, regulatory submissions, and pharmaceutical documentation within a leading CRO environment.
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Frank Scottile Blvd |Missouri :
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Copenhagen | Denmark |Europe :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Koropi | Athens |Greece :
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Croatia |Zagreb :
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Tallinn |Hà Nội :
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