FSP Medical Writing Program Manager
Location: Remote – India
Job Type: Full-Time
Category: Clinical Research | Medical Writing | FSP
Job ID: R-01331944
Work Mode: Fully Remote
Experience Required: 8+ Years
Thermo Fisher Scientific, through its PPD® Clinical Research Services portfolio, is a global leader in contract research, supporting the development and delivery of life-changing therapies. With clinical trials conducted in more than 100 countries, Thermo Fisher Scientific integrates laboratory, digital, and decentralized clinical trial solutions to accelerate research and improve patient outcomes worldwide.
Driven by a mission to make the world healthier, cleaner, and safer, the organization empowers its teams with world-class resources, innovative technologies, and continuous learning opportunities.
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 involves managing large-scale medical writing and narrative development programs, leading multi-writer teams, and serving as a key client-facing stakeholder.
The position offers the opportunity to mentor medical writers, oversee complex regulatory document portfolios, and ensure high standards of quality, compliance, and delivery across global clinical programs.
Develop, manage, and adapt project plans, timelines, budgets, and forecasts for large medical writing programs
Act as the primary point of contact for program-level risk identification, escalation, and resolution
Ensure compliance with internal quality standards, SOPs, and global regulatory guidelines across all deliverables
Maintain consistency, accuracy, and inspection readiness of study- and program-level documents
Define, track, and report key performance metrics for assigned programs
Provide senior-level review and strategic input on medical and regulatory documents
Train, mentor, and guide medical writers on processes, tools, and program management best practices
Lead and coordinate cross-functional study teams in a matrixed environment
Serve as a primary author or contributor for complex regulatory documents, as required
Bachelor’s degree in a scientific discipline (Life Sciences, Pharmacy, Medicine, or related field)
Advanced degree (Master’s, PhD, MD, PharmD) preferred
Minimum 8+ years of relevant experience in medical writing and program or project management
Proven experience managing large-scale medical writing or narrative development programs
Prior experience in the pharmaceutical, biotechnology, or CRO industry strongly preferred
Certifications in medical writing or regulatory affairs (AMWA, EMWA, RAC) are advantageous
Strong program and project management capabilities, including resource planning and multi-writer coordination
Advanced medical writing, editing, and data interpretation skills
In-depth knowledge of global, regional, and country-specific regulatory document development guidelines
Excellent written, verbal, and presentation communication skills
Demonstrated ability to lead, mentor, and develop junior and mid-level medical writers
High level of independence, sound judgment, and problem-solving ability
Strong stakeholder management, negotiation, and client engagement skills
Self-motivated, adaptable, and able to perform in a fast-paced global environment
Standard work schedule (Monday to Friday)
Fully remote role based in India
Office-based or home-office environment
Be part of a globally recognized clinical research organization
Work on high-impact clinical research programs with global exposure
Access award-winning learning and development programs
Enjoy a flexible, remote-friendly work culture that values work-life balance
Competitive compensation and comprehensive employee benefits
Collaborative environment with strong mentorship and career growth pathways
Thermo Fisher Scientific is an Equal Opportunity Employer. Employment decisions are based on business needs, qualifications, and merit, without regard to race, religion, gender, sexual orientation, age, disability, veteran status, or any other protected characteristic.
Medical Writing Program Manager Jobs India, FSP Medical Writing Careers, Remote Medical Writing Jobs India, Clinical Research Program Manager India, CRO Medical Writing Jobs, Thermo Fisher Scientific Careers India.
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