Medical Writing Program Manager – QC and Publishing Lead (FSP)
Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Location: Bangalore, India | Fully Remote
Job Type: Full-Time | Remote (FSP Model)
Experience: Typically 8+ Years (Medical Writing / Document Review / Clinical Research)
Qualification: Bachelor’s Degree in Scientific Discipline (Advanced Degree Preferred)
Salary Range: Not Specified
Job Overview
Thermo Fisher Scientific is expanding its Medical Writing Functional Service Provider (FSP) team and is seeking a Medical Writing Program Manager – QC and Publishing Lead to oversee document review and publishing activities for a client-dedicated program.
The Program Manager will act as the primary point of contact for the client, ensuring high-quality review, compliance, and timely delivery of regulatory clinical documents. The role involves managing a team responsible for quality control, document review, and regulatory publishing while ensuring alignment with global regulatory requirements.
This position plays a critical role in ensuring that clinical trial documentation meets regulatory standards and submission timelines, supporting pharmaceutical development programs across multiple therapeutic areas.
The role requires strong project management, leadership, regulatory knowledge, and medical writing expertise, particularly related to regulatory submission documents such as Clinical Study Reports and Protocols.
Key Responsibilities
1. Program Management & Client Oversight
Act as the primary liaison between the client and the document review team.
Manage client expectations, timelines, and deliverables for multiple document review activities.
Handle escalation of risks related to project timelines, quality issues, or resource allocation.
Ensure high levels of client satisfaction through proactive communication and issue resolution.
Coordinate project planning and monitoring activities to ensure milestones are achieved.
2. Project Planning & Resource Management
Develop and maintain project timelines, review schedules, and resource allocation plans.
Forecast staffing requirements and allocate reviewers based on project needs.
Monitor progress of review activities and adjust project plans to meet deadlines.
Ensure optimal utilization of personnel and technology resources.
Manage competing priorities across multiple programs and submissions.
3. Medical Writing Quality Control & Document Review
Perform senior-level review of clinical and regulatory documents.
Ensure document consistency, clarity, and compliance with regulatory guidelines.
Review documents for scientific accuracy, formatting consistency, and editorial quality.
Ensure that document review processes follow internal quality standards and SOPs.
Support quality assurance efforts across multiple document types.
4. Regulatory Document Expertise
Serve as a primary reviewer for regulatory submission documents including:
Clinical Study Reports (CSR)
Clinical Protocols
Investigator Brochures (IB)
Informed Consent Forms (ICF)
Other regulatory submission documentation.
Ensure documents comply with global regulatory requirements.
Support preparation of submission-ready documentation for regulatory agencies.
Ensure documentation aligns with guidelines from organizations such as the
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
5. Quality Metrics & Process Oversight
Develop and monitor performance metrics related to document review activities.
Track quality indicators and turnaround times for document reviews.
Implement process improvements to enhance document review efficiency.
Ensure consistency in quality processes across multiple projects and programs.
Identify risks and implement mitigation strategies to maintain quality standards.
6. Training & Mentorship
Train new document reviewers on review processes and regulatory requirements.
Provide technical guidance on document review methodologies.
Mentor junior medical writers and reviewers to maintain quality standards.
Ensure team members understand SOPs, regulatory expectations, and document templates.
Support continuous skill development within the document review team.
7. Cross-Functional Collaboration
Collaborate with clinical development, regulatory affairs, and data management teams.
Participate in cross-functional meetings to support document development and review strategies.
Work closely with publishing teams to ensure proper formatting and submission readiness.
Provide document review insights to clinical and regulatory stakeholders.
Ensure alignment between writing, quality review, and submission processes.
Required Skills
Medical Writing & Document Review Expertise
Extensive experience reviewing clinical and regulatory documents.
Strong editorial, proofreading, and document formatting skills.
Understanding of document lifecycle management in clinical trials.
Ability to identify inconsistencies, data discrepancies, and compliance issues.
Project Management & Resource Planning
Strong experience managing complex projects and timelines.
Ability to allocate resources effectively across multiple programs.
Experience tracking deliverables and maintaining project schedules.
Capability to manage competing priorities under tight deadlines.
Regulatory Knowledge & Compliance
Knowledge of global regulatory documentation standards.
Understanding of clinical trial documentation processes.
Familiarity with regulatory submission requirements and review workflows.
Awareness of global regulatory frameworks including
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines.
Communication & Leadership
Strong communication skills with internal teams and external clients.
Ability to lead teams and manage stakeholders effectively.
Experience mentoring and training junior staff.
Ability to make independent decisions and resolve project issues.
Preferred Qualifications
Advanced degree in life sciences or a related scientific discipline.
Experience in pharmaceutical or CRO environments.
Experience managing document review teams or regulatory publishing operations.
Professional certifications such as:
American Medical Writers Association (AMWA)
European Medical Writers Association (EMWA)
Regulatory Affairs Professionals Society (RAPS)
Experience working within Functional Service Provider (FSP) models.
Key Competencies
Medical writing quality control and regulatory document review
Clinical trial documentation management
Project planning and resource allocation
Regulatory compliance and submission readiness
Client communication and stakeholder management
Leadership and mentorship within medical writing teams
About the Company
Thermo Fisher Scientific is a global leader in scientific services, providing technologies and solutions that enable research, drug development, and healthcare innovation worldwide.
Through its clinical research division, PPD Clinical Research Services, the company supports pharmaceutical and biotechnology organizations by delivering end-to-end clinical trial services including clinical operations, data management, regulatory support, and medical writing.
Operating in more than 100 countries with over 100,000 employees, the organization helps accelerate the development of life-changing therapies while maintaining the highest standards of scientific and regulatory excellence.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
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Cork | Dublin | Limerick | Waterford |Ulster :
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Galway |County Dublin :
Swords |Republic of China :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
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Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
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Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Witney |Ontario :
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Peru | Argentina |Brazil :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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Japan | Saitama |Tokyo :
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Kfar Saba | Be'Er Sheva | Tel Aviv | Netanya | Yavne |Remote :
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Rabigh | King Abdullah Economic City | Jeddah | Riyadh | Najran | Khulais |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
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