Principal Medical Writer – Clinical Research
Location: Fully Remote – India
Job Type: Full-Time
Job ID: R-01332281
Category: Clinical Research / Medical Writing
Work Schedule: Standard (Monday to Friday)
About the Organization
Our Clinical Research Services team operates at the forefront of global drug development, supporting the delivery of innovative therapies that address complex and critical health challenges worldwide. As part of a leading global Contract Research Organization (CRO) and the PPD® clinical research portfolio, the team brings deep scientific, regulatory, and therapeutic expertise to every stage of clinical development. We foster a collaborative, quality-driven environment focused on operational excellence and regulatory compliance.
Role Overview
The Principal Medical Writer will provide senior-level medical and scientific writing expertise across a broad range of clinical and regulatory documents. This role involves end-to-end ownership of document planning, development, review, and delivery, while serving as a subject matter expert and lead writer on complex programs. The position also includes mentoring junior writers, advising on regulatory strategy and best practices, and supporting program management activities to ensure high-quality, compliant, and timely deliverables.
Key Responsibilities
Lead the planning, writing, and review of high-quality clinical and regulatory documents, including clinical study reports (CSRs), study protocols, investigator’s brochures (IBs), INDs, MAAs, and other complex program-level submissions.
Research, interpret, and summarize clinical data to support clear, accurate, and scientifically sound documentation.
Serve as primary author and senior reviewer for routine and complex medical writing deliverables, ensuring consistency, clarity, and regulatory compliance.
Provide strategic guidance on document development approaches, applicable regulations, and industry best practices across global regulatory regions.
Mentor, train, and guide junior medical writers and program managers on document standards, software tools, regulatory requirements, and therapeutic area knowledge.
Act as a subject matter expert to develop, implement, and refine best practices, methodologies, and process improvements within medical writing operations.
Ensure adherence to quality systems, SOPs, and performance metrics for assigned projects.
Serve as backup program manager as required, supporting timeline development, budget oversight, forecasting, and contract modifications.
Participate in bid defenses, client presentations, and proposal development, including review of scientific and regulatory content.
Represent the medical writing function in project initiation meetings, cross-functional reviews, and client-facing discussions.
Experience and Qualifications Required
Bachelor’s degree in a scientific discipline or equivalent formal academic qualification; advanced degree preferred.
Minimum 8+ years of professional experience in medical writing, with demonstrated responsibility for complex clinical and regulatory documents.
Proven experience managing and directing large-scale or complex medical writing projects within a pharmaceutical or CRO environment.
Strong knowledge of global, regional, and country-specific regulatory document development guidelines.
In-depth expertise in one or more specialty areas, such as clinical development, regulatory submissions, therapeutic areas, preclinical documentation, or scientific communications.
Advanced data interpretation, scientific writing, editing, and proofreading skills.
Excellent project management, organizational, and time management capabilities.
Strong leadership, mentoring, and stakeholder management skills.
Excellent written, verbal, presentation, and negotiation skills with the ability to work independently and make sound decisions.
Professional certifications in medical writing or regulatory affairs (AMWA, EMWA, RAC) are highly desirable.
Demonstrated ability to lead teams, mentor junior staff, and drive continuous improvement initiatives.
Why Join This Opportunity
Fully remote role offering flexibility and global exposure within a leading CRO environment.
Opportunity to lead high-impact clinical and regulatory documentation supporting innovative therapies.
Collaborative, quality-focused culture that values expertise, leadership, and professional growth.
Competitive compensation and long-term career development opportunities.
How to Apply
Qualified candidates with strong medical writing leadership experience are encouraged to apply through the official careers portal. Applications will be reviewed on a rolling basis.
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