FSP Medical Writing Program Manager – Remote (India)
Job ID: R-01331944
Location: Remote, India
Employment Type: Full-Time
Category: Clinical Research / Medical Writing
Work Mode: Fully Remote
Work Schedule: Monday to Friday
About the Organization
Thermo Fisher Scientific, through its PPD® Clinical Research Services portfolio, is a globally recognized contract research organization (CRO) supporting the development of innovative, life-changing therapies. With clinical trials conducted across more than 100 countries, the organization delivers integrated laboratory, digital, and decentralized clinical trial solutions that advance global healthcare.
Driven by a mission to make the world healthier, cleaner, and safer, Thermo Fisher Scientific empowers its teams with the tools, resources, and opportunities needed to make a meaningful global impact.
Position Summary
Thermo Fisher Scientific is expanding its Medical Writing Functional Service Provider (FSP) team in India and is seeking an experienced Medical Writing Program Manager. This senior-level role is ideal for professionals with a strong background in managing large-scale medical writing and regulatory narrative projects within the pharmaceutical or CRO industry.
The Program Manager will be responsible for overseeing complex medical writing programs, ensuring quality and compliance, managing timelines and budgets, engaging with global clients, and mentoring medical writing teams.
Key Responsibilities
Plan, develop, monitor, and optimize project timelines, budgets, and forecasts for large medical writing programs
Act as the primary escalation point for risks related to quality, timelines, or financial performance
Ensure adherence to internal quality standards and global regulatory documentation guidelines
Maintain consistency and accuracy across study-level and program-level medical writing deliverables
Define, track, analyze, and report performance metrics for assigned programs
Provide senior-level scientific, editorial, and compliance review of medical writing documents
Train, mentor, and guide medical writers on program management processes and technical requirements
Serve as a primary author or contributor for study-level and program-level regulatory documents when required
Lead cross-functional teams and collaborate effectively with global stakeholders
Education and Experience Requirements
Bachelor’s degree in a scientific discipline (Life Sciences, Pharmacy, Medicine, or related field)
Advanced degree preferred (MS, PhD, PharmD, or equivalent)
Minimum 8+ years of relevant experience in medical writing, clinical research, or regulatory documentation
Demonstrated experience managing large-scale medical writing or narrative development programs
Prior experience in a pharmaceutical company or CRO environment strongly preferred
Professional certifications such as AMWA, EMWA, or RAC are considered an advantage
Required Skills and Competencies
Strong program and project management skills, including resource planning and multi-writer coordination
Excellent medical writing, data interpretation, editing, and proofreading abilities
In-depth knowledge of global, regional, and local regulatory and clinical documentation standards
Exceptional written and verbal communication and presentation skills
Proven leadership and team management capabilities
Strong negotiation, decision-making, and problem-solving skills
High level of independence, adaptability, and professional judgment
Ability to mentor and develop junior and mid-level medical writers
What the Company Offers
Competitive salary aligned with global market standards
Comprehensive benefits package focused on health, well-being, and work-life balance
Fully remote and flexible working model
Access to award-winning learning and professional development programs
Collaborative, inclusive, and growth-oriented work culture
Opportunity to work on global clinical research programs with real-world patient impact
Company Values
Thermo Fisher Scientific operates with a commitment to Integrity, Intensity, Innovation, and Involvement. With a global workforce of over 100,000 professionals, the organization values diversity, collaboration, and scientific excellence.
Apply Now
Take the next step in your medical writing leadership career. Join PPD, part of Thermo Fisher Scientific, and contribute to advancing global clinical research and patient safety.
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