Principal Medical Writer
Location: Remote – India
Work Mode: Fully Remote
Employment Type: Full-Time
Job ID: R-01332281
Category: Clinical Research / Medical Writing
About the Organization
Our Clinical Research Services team is at the forefront of advancing innovative therapies from development to market. As part of a leading global Contract Research Organization (CRO) supporting the PPD clinical research portfolio, we bring deep scientific, regulatory, and operational expertise to address some of the world’s most complex health challenges.
Role Overview
The Principal Medical Writer is a senior leadership role responsible for delivering high-quality medical and scientific documents across the clinical development lifecycle. This position provides strategic direction on document development, ensures regulatory and quality compliance, and serves as a subject matter expert across therapeutic and regulatory domains.
In addition to hands-on writing, the role includes mentoring junior writers, leading document strategy discussions, and supporting program-level activities to drive operational excellence.
Key Responsibilities
Medical & Scientific Writing
Lead the planning, development, and delivery of complex medical and scientific documents, including clinical study reports, protocols, investigator brochures, INDs, and MAAs
Serve as primary author for program-level and regulatory documents, ensuring clarity, scientific accuracy, and compliance
Summarize and interpret clinical data to produce high-quality, submission-ready documentation
Leadership & Quality Oversight
Provide senior-level review of routine and complex documents, ensuring adherence to global and regional regulatory guidelines
Train, mentor, and guide junior medical writers and program managers on document preparation, regulatory standards, and best practices
Act as a subject matter expert in assigned therapeutic areas and document types
Strategy, Process & Program Support
Advise internal and external stakeholders on document strategy, regulatory expectations, and industry best practices
Lead process improvement initiatives, including the development and review of document standards, methodologies, and performance metrics
Ensure compliance with internal quality systems and client-specific processes
Program & Stakeholder Management
Serve as backup program manager as required, supporting timeline development, scope management, budgeting, and forecasting
Identify and manage out-of-scope activities, contract modifications, and risk mitigation strategies
Support business development activities, including proposal development, client presentations, and bid defense meetings
Represent the medical writing function at project launch, review, and cross-functional team meetings
Required Qualifications and Experience
Bachelor’s degree in a scientific discipline or equivalent; advanced degree preferred
8+ years of progressive experience in medical writing within a pharmaceutical or CRO environment
Demonstrated experience leading and managing complex medical writing projects across multiple document types
Strong knowledge of global, regional, and local regulatory document development guidelines
In-depth expertise in one or more specialty areas, such as regulatory submissions, clinical development, therapeutic areas, or medical communications
Professional certifications in medical writing or regulatory affairs (AMWA, EMWA, RAC) are advantageous
Excellent data interpretation, scientific writing, editing, and proofreading skills
Strong project management, stakeholder engagement, and decision-making capabilities
Proven ability to mentor, coach, and lead junior team members
Work Schedule & Environment
Standard work schedule (Monday to Friday)
Fully remote work environment within India
Why Join Us
This role offers the opportunity to lead high-impact medical writing initiatives within a globally recognized clinical research organization. You will work with cross-functional experts, influence regulatory strategies, and contribute directly to the delivery of innovative therapies that improve patient outcomes worldwide.
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