Job Title: Principal Medical Writer
Job ID: R-01332281
Location: Remote – India
Job Type: Full-Time
Category: Clinical Research
Work Mode: Fully Remote
Experience Required: 8+ years
About the Company
Our Clinical Research Services team plays a critical role in advancing innovative therapies to market. As part of a leading global Contract Research Organization (CRO) powering the PPD clinical research portfolio, we bring deep scientific expertise, regulatory excellence, and operational rigor to drug development programs addressing some of the world’s most complex health challenges.
Role Overview
We are seeking an experienced Principal Medical Writer to lead the development of high-quality clinical and regulatory documents across multiple therapeutic areas. This role involves end-to-end ownership of document strategy, authoring, senior-level review, team mentorship, and cross-functional collaboration with internal and external stakeholders. The Principal Medical Writer serves as a subject matter expert and provides strategic guidance on regulatory requirements, best practices, and document development processes.
Key Responsibilities
Lead the planning, authoring, review, and finalization of clinical study reports, study protocols, investigator brochures, INDs, MAAs, and other complex regulatory and scientific documents.
Serve as primary author for program-level and high-complexity documents, ensuring scientific accuracy, clarity, and regulatory compliance.
Provide senior-level document review, quality oversight, and approval for routine and complex medical writing deliverables.
Mentor, train, and guide junior medical writers and program managers on document standards, regulatory requirements, therapeutic knowledge, and writing tools.
Advise internal teams and clients on document development strategy, regulatory expectations, and industry best practices.
Ensure compliance with internal quality systems, SOPs, and global regulatory guidelines across assigned projects.
Lead and contribute to process improvement initiatives, development of best practices, and performance metrics for medical writing deliverables.
Act as backup Program Manager when required, supporting timelines, budgets, forecasting, scope management, and contract modifications.
Support business development activities, including proposal content development, client presentations, bid defenses, and capability meetings.
Represent the medical writing function in project launch meetings, cross-functional reviews, and stakeholder discussions.
Required Experience
Minimum 8+ years of relevant experience in medical writing within a pharmaceutical company or CRO environment.
Proven experience managing and leading complex, multi-document medical writing programs.
Demonstrated ability to independently oversee high-impact regulatory and clinical documentation projects.
Educational Qualifications
Bachelor’s degree in a scientific discipline or equivalent formal academic qualification.
Advanced degree (Master’s or PhD) preferred.
Certifications such as AMWA, EMWA, or RAC are considered an advantage.
Equivalent combinations of education, training, and directly related experience may be considered.
Key Skills & Competencies
Strong knowledge of global, regional, and country-specific regulatory and document development guidelines.
Deep expertise in one or more areas including clinical development, regulatory submissions, therapeutic writing, or scientific communications.
Exceptional medical writing, data interpretation, editing, and proofreading skills.
Advanced project management and stakeholder communication abilities.
Strong leadership skills with the ability to mentor, influence, and guide teams.
High level of independence, sound judgment, and problem-solving capability.
Why Join Us
Fully remote opportunity within a globally recognized CRO.
Leadership role with strategic influence on high-impact drug development programs.
Collaborative, science-driven work culture with strong emphasis on quality and innovation.
Long-term career growth in global medical writing and regulatory leadership.
Apply now through ThePharmaDaily.com to take the next step in your medical writing career with a world-class clinical research organization.
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