FSP Medical Writing Program Manager – Remote (India)
Location: Remote, India
Job Type: Full-Time, Fully Remote
Category: Clinical Research / Medical Writing
Job ID: R-01331944
About the Role
Thermo Fisher Scientific is seeking an experienced FSP Medical Writing Program Manager to lead and manage large-scale medical writing projects within our Global Clinical Research Services (PPD) portfolio. This fully remote role in India provides the opportunity to drive high-impact regulatory writing programs, mentor medical writers, and engage with clients at a strategic level.
As a Program Manager, you will ensure the delivery of high-quality study- and program-level regulatory documents, manage resources, timelines, and budgets, and maintain compliance with global regulatory standards. This role is ideal for professionals with extensive experience in pharmaceutical or CRO medical writing operations who are ready to lead complex, multi-writer projects.
Key Responsibilities
Lead, plan, and manage large-scale FSP medical writing programs, including timelines, budgets, and resource allocation.
Serve as the primary point of contact for risk escalation, addressing issues related to project quality, scope, or deadlines.
Ensure consistency, accuracy, and compliance across all regulatory documents and program deliverables.
Monitor performance metrics and implement process improvements to enhance efficiency and quality.
Provide senior-level review and guidance on study- and program-level regulatory documents, including clinical study reports, protocols, and related submissions.
Mentor, train, and support medical writers on program management best practices, technical writing standards, and regulatory guidelines.
Collaborate closely with cross-functional teams and clients to maintain alignment and ensure program success.
Experience Required
8+ years of relevant experience in medical writing, with significant exposure to large, multi-writer regulatory projects.
Proven track record in managing and delivering complex medical writing programs in pharmaceutical or CRO settings.
Experience in regulatory submissions and familiarity with global document development guidelines.
Educational Qualifications
Bachelor’s degree in a scientific discipline or equivalent.
Advanced degree (MSc, PharmD, MD, PhD) preferred.
Professional certifications in medical writing (AMWA, EMWA, RAC) are advantageous.
Key Skills & Competencies
Strong project management and resource planning skills for multi-writer projects.
Expertise in medical writing, data interpretation, and regulatory documentation.
Excellent oral, written, and presentation skills.
Ability to mentor, lead, and develop junior writers.
High adaptability, problem-solving, and independent decision-making capabilities.
Proficiency in document management systems, MS Office Suite, and client-specific templates.
Strong negotiation and stakeholder management skills.
Why Join Thermo Fisher Scientific – PPD Clinical Research Services
Lead high-impact clinical research programs that advance health outcomes globally.
Work fully remote in India while collaborating with global teams and clients.
Competitive salary and comprehensive benefits package, emphasizing health, well-being, and professional development.
Opportunities to mentor and grow within a collaborative, global organization.
Join a mission-driven company focused on making the world healthier, cleaner, and safer.
Who Should Apply
This role is ideal for experienced medical writing professionals with a proven track record in program management, regulatory writing, and team leadership, seeking to work in a dynamic, remote, and globally connected environment.
Gujarat :
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