Principal Medical Writer – Clinical Research (Fully Remote)
Location: Remote, India
Job ID: R-01332281
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 8+ Years in Medical Writing
ThePharmaDaily.com is featuring a senior leadership opportunity for a Principal Medical Writer within a leading global Contract Research Organization (CRO) supporting advanced clinical research services. This fully remote role in India is designed for experienced medical writing professionals with strong regulatory expertise, therapeutic area knowledge, and project leadership capabilities.
This position is ideal for candidates seeking strategic responsibility in clinical documentation, regulatory submissions, and cross-functional program oversight within global drug development programs.
Role Overview
The Principal Medical Writer provides strategic direction and high-level scientific writing support across complex clinical and regulatory projects. Acting as a lead writer and subject matter expert, this role ensures the development of high-quality, compliant documents while mentoring junior writers and contributing to program management activities.
The position requires deep expertise in global regulatory documentation, strong leadership skills, and the ability to drive process excellence in a fully remote, globally collaborative environment.
Key Responsibilities
Research, draft, and edit clinical study reports (CSRs), study protocols, and clinical data summaries
Serve as primary author for complex regulatory and program-level documents including Investigator’s Brochures (IBs), INDs, and MAAs
Provide senior-level review and quality oversight of routine and complex medical writing deliverables
Mentor, train, and guide junior medical writers and program managers
Advise on document development strategy, regulatory compliance, and industry best practices
Ensure adherence to global, regional, and national regulatory submission guidelines
Lead process improvement initiatives and develop best practices for document development
Manage performance metrics and quality standards for assigned projects
Serve as backup program manager, supporting timelines, budgets, forecasting, and contract modifications
Contribute to business development efforts including proposal writing, bid defense meetings, and client presentations
Represent the department at project launch, review, and cross-functional team meetings
Required Qualifications
Bachelor’s degree in a scientific discipline or equivalent qualification
Advanced degree (Master’s or PhD) preferred
Minimum 8+ years of experience in medical writing within the pharmaceutical or CRO industry
Proven experience managing and directing complex medical writing projects
Strong expertise in global regulatory submission guidelines and document standards
Demonstrated experience authoring IBs, INDs, MAAs, CSRs, and study protocols
Excellent data interpretation, scientific writing, grammar, editing, and proofreading skills
Advanced project management and organizational abilities
Strong leadership, mentoring, and team development skills
Excellent written and verbal communication and presentation capabilities
High level of independence in decision-making and problem-solving
Preferred Qualifications
Certification in medical writing or regulatory affairs (AMWA, EMWA, RAC)
Therapeutic area specialization (preclinical, regulatory submissions, clinical communications, etc.)
Experience supporting bid defense meetings and client-facing regulatory discussions
Work Environment
Fully remote role based in India
Standard Monday–Friday schedule
Collaboration with global cross-functional clinical and regulatory teams
This opportunity is ideal for senior medical writing professionals seeking strategic leadership roles in global clinical research, regulatory documentation, and pharmaceutical development within a high-performing CRO environment.
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Bangor | Brewer |New Jersey :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Dún Laoghaire |Galway :
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Swords |Republic of China :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
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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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Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Bangkok |Israel :
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