Position: Program Manager – Medical Writing
Location: Remote, India
Job Type: Full-time
Job ID: R-01331601
Category: Clinical Research
PPD® Clinical Research is a leading global contract research organization (CRO) delivering scientific and clinical expertise to accelerate drug development. The team drives the development of therapies addressing complex health challenges worldwide.
Lead client programs with high visibility, manage client relationships, and ensure timely delivery and quality of medical writing programs. Serve as subject matter expert, develop project plans, monitor budgets and timelines, and mentor junior writers.
1. Program & Project Management
Develop, monitor, and adapt project plans, timelines, budgets, forecasts, and contract modifications.
Serve as liaison between departments for contract management and modifications.
Evaluate and escalate risks related to project quality, timelines, or budgets.
Develop, review, and manage performance metrics for assigned programs.
2. Client Engagement & Business Development
Act as primary point of contact for clients at program level.
Assist senior management and business development in securing new business.
Develop and deliver client presentations, proposals, and budgets.
Support contract negotiations.
3. Medical Writing & Review
Serve as backup medical writer as needed: research, write, and edit clinical study reports, protocols, and complex documents (IBs, INDs, MAAs).
Provide senior review of project documents to ensure compliance and quality.
Ensure adherence to global, regional, and client-specific medical writing standards.
4. Mentorship & Training
Provide training to medical writers on processes, project management, and technical aspects.
Mentor junior staff and lead by example in best practices for medical writing projects.
Education & Experience:
Bachelor’s degree in a scientific discipline or equivalent; advanced degree preferred.
Minimum 8+ years of experience in managing complex medical writing projects.
Experience in pharmaceutical/CRO industry preferred.
Additional medical writing qualifications (AMWA, EMWA, RAC) advantageous.
Skills & Competencies:
Strong program management skills (budgeting, forecasting, resource management).
In-depth knowledge of global, regional, and national document development guidelines.
Expertise in specialty areas such as preclinical, therapeutic, regulatory submissions, communications, etc.
Excellent interpersonal, oral, written communication, and presentation skills.
Strong negotiation skills and decision-making ability.
Self-motivated, adaptable, and capable of problem-solving independently.
Ability to mentor and lead junior staff effectively.
Gujarat :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
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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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Auckland |New Zealand :
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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 :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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