Job Title: FSP Medical Writing Program Manager – Remote, India
Job ID: R-01331944
Job Type: Full-time
Category: Clinical Research
Location: Remote, India (Fully Remote)
Thermo Fisher Scientific’s Clinical Research Services, through its PPD® portfolio, is a global leader in delivering innovative therapies and advancing healthcare. With clinical trials spanning over 100 countries, our teams support life-changing research with excellence, precision, and impact.
We are expanding our Medical Writing FSP Team in India and are seeking a skilled Program Manager to oversee large-scale narrative projects. This role combines project leadership, client engagement, and mentoring of medical writing professionals to deliver high-quality regulatory and scientific documentation.
Lead and manage large-scale medical writing programs, including timelines, resource allocation, budgets, and forecasts.
Serve as the primary point of contact for project risks, evaluating and resolving issues related to quality, budget, or timeline.
Ensure compliance with internal quality standards and regulatory requirements across all project deliverables.
Develop, monitor, and manage performance metrics for assigned projects, ensuring consistent execution across multiple documents and teams.
Provide senior-level review of study- and program-level materials, ensuring scientific accuracy and adherence to guidelines.
Mentor, train, and guide medical writers on project management processes, technical writing standards, and best practices.
Contribute as a primary author on complex regulatory documents, including study protocols, clinical study reports, and other program-level documentation.
Collaborate with cross-functional teams to support client engagement and ensure operational excellence.
Bachelor’s degree in Life Sciences, Pharmacy, or a related scientific discipline; advanced degree preferred.
Minimum 8+ years of relevant experience, including managing and directing large-scale medical writing projects.
Proven experience in the pharmaceutical or CRO industry.
Additional professional medical writing credentials (AMWA, EMWA, RAC) are highly desirable.
Strong project management skills, including resource planning, timeline management, and multi-writer coordination.
Excellent scientific and medical writing skills, with proficiency in grammar, editing, and data interpretation.
Deep knowledge of global, regional, and national regulatory guidelines for document development.
Strong oral and written communication, presentation, and negotiation skills.
Ability to lead and mentor study teams and entry-level medical writers effectively.
Self-motivated, adaptable, and capable of independent decision-making and problem-solving.
High degree of judgment, professionalism, and attention to detail.
Global Impact: Contribute to life-changing therapies and healthcare solutions worldwide.
Career Development: Access to award-winning learning programs and opportunities for professional growth.
Work-Life Balance: Flexible working culture with support for remote operations.
Collaborative Environment: Work alongside experienced professionals in a supportive, knowledge-sharing culture.
Competitive Compensation: Attractive salary and comprehensive benefits package focused on health, wellness, and career development.
Thermo Fisher Scientific is a global leader in serving science, with more than 100,000 employees worldwide. Our mission is to enable our customers to make the world healthier, cleaner, and safer. Through innovation, collaboration, and integrity, we advance life sciences research, improve patient outcomes, and drive scientific discovery. Learn more at www.thermofisher.com.
Equal Opportunity Employer: Thermo Fisher Scientific fosters a diverse, inclusive, and equitable workplace.
Apply Now to join a global team of experts shaping the future of medical writing and clinical research.
Gujarat :
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