FSP Medical Writing Program Manager – Remote, India
Location: Remote, India
Job Type: Full-time
Category: Clinical Research / Medical Writing
Experience Required: 8+ years
Job ID: R-01331944
Overview
Thermo Fisher Scientific, through its PPD® clinical research services, is a global leader in delivering innovative therapies and advancing patient health. We are seeking a FSP Medical Writing Program Manager to lead our growing Medical Writing Full-Service Provider (FSP) team in India.
This role focuses on large-scale narrative projects in medical writing, combining project management, client engagement, and team leadership. The ideal candidate will have extensive experience in pharmaceutical/CRO medical writing projects, strong knowledge of regulatory document requirements, and the ability to mentor and develop junior writers.
Key Responsibilities
Develop, monitor, and adapt project plans, timelines, and budgets for large multi-writer programs.
Serve as the primary point of contact for risk escalation, evaluating and resolving quality, budget, or timeline issues.
Ensure compliance with quality processes and regulatory requirements across all assigned programs.
Provide senior-level review of project documents and deliverables.
Mentor and train medical writers on program management, regulatory document preparation, and technical writing standards.
Collaborate with clients and internal teams to ensure effective communication, operational efficiency, and high-quality deliverables.
May act as primary author or provide input on study- and program-level regulatory documents.
Develop, review, and manage performance metrics for assigned projects.
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, or a related scientific discipline; advanced degree preferred.
8+ years of experience in medical writing or clinical research, with significant experience in managing large-scale narrative projects.
Prior experience in the pharmaceutical or CRO industry.
Additional certifications in medical writing (AMWA, EMWA, RAC) are advantageous.
Proven ability to mentor and lead junior staff.
Skills & Competencies
Strong project management skills, including resource allocation, timeline planning, and budget oversight.
Excellent medical writing and data interpretation skills, including grammar, editorial precision, and proofreading.
Deep knowledge of global, regional, and national document development guidelines.
Exceptional communication, presentation, and negotiation skills.
Ability to lead study teams, make independent decisions, and solve complex problems.
Self-motivated, adaptable, and committed to delivering high-quality outputs under tight deadlines.
Why Join Thermo Fisher Scientific
Fully remote role with flexibility to work from anywhere in India.
Lead global-scale medical writing projects impacting patient health and regulatory compliance.
Access to award-winning learning and development programs to advance your career.
Collaborative and inclusive culture fostering mentorship, knowledge-sharing, and professional growth.
Competitive salary, comprehensive benefits, and work-life balance support.
Thermo Fisher Scientific is committed to building diverse and inclusive teams that drive innovation, operational excellence, and patient-centric outcomes.
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