Title: Principal Medical Writer
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research – Remote
Company Overview:
Join a leading global Contract Research Organization (CRO) dedicated to advancing clinical research and accelerating the development of life-changing therapies. Our Clinical Research Services team brings high-caliber scientific and clinical expertise to deliver innovative solutions for complex healthcare challenges worldwide. At PPD®, you will contribute to a culture of excellence, collaboration, and innovation, supporting global clients in bringing cures to market efficiently.
Role Overview:
The Principal Medical Writer provides high-quality medical and scientific writing from planning through final delivery, ensuring documents meet regulatory, scientific, and client-specific standards. This role leads document development, mentors junior writers, advises on strategy and best practices, and may serve as a backup program manager. The Principal Medical Writer ensures operational excellence in all aspects of medical writing projects while maintaining compliance with internal and external guidelines.
Key Responsibilities:
Research, write, and edit clinical study reports, protocols, and other regulatory documents.
Serve as primary author for complex scientific documents including Investigator’s Brochures (IBs), INDs, and Marketing Authorization Applications (MAAs).
Review and provide guidance on documents prepared by junior team members, ensuring quality and regulatory compliance.
Mentor and train junior medical writers and program managers in document preparation, therapeutic area knowledge, and regulatory requirements.
Develop, review, and implement best practices and process improvements for medical writing workflows.
Manage performance metrics, timelines, budgets, forecasts, and contract modifications for assigned projects.
Support business development efforts, including client presentations, proposal reviews, and bid defense meetings.
Represent the medical writing team at project launch meetings, review meetings, and cross-functional team meetings.
Ensure adherence to global, regional, and national document development guidelines, including regulatory, scientific, and therapeutic requirements.
Qualifications & Experience:
Bachelor’s degree in a scientific discipline; advanced degree preferred.
Minimum 8+ years of experience in medical writing or related scientific documentation roles, preferably within the pharmaceutical or CRO industry.
Proven experience managing and directing complex medical writing projects.
Advanced knowledge of global and regional regulatory and document development guidelines.
Expertise in one or more therapeutic or specialty areas such as preclinical, regulatory submissions, clinical communications, or medical affairs.
Certification in medical writing (AMWA, EMWA, RAC) is advantageous.
Skills & Competencies:
Exceptional medical writing, data interpretation, proofreading, and editorial skills.
Strong project management abilities and experience in multi-functional team collaboration.
Advanced interpersonal, communication, presentation, and negotiation skills.
Ability to mentor and lead junior staff with high judgment and independent decision-making.
Strong problem-solving skills and attention to detail.
Why Join Us:
Work remotely with a globally recognized CRO, contributing to life-changing therapies.
Lead high-impact medical writing projects while mentoring and developing junior writers.
Access professional growth opportunities, advanced training, and industry exposure.
Equal Opportunity Employer:
We are committed to fostering inclusion, diversity, and equal employment opportunities. All qualified applicants will be considered without regard to race, religion, gender, age, disability, sexual orientation, or any legally protected characteristic.
Apply Now: Advance your career as a Principal Medical Writer and shape the future of clinical research with global impact.
Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
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 :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Netherlands |Remote Australia :
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Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Mississauga | Renfrew | Richmond Hill | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
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Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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