Job Title: Program Manager – Medical Writing
Location: Remote, India
Job ID: R-01331601
Job Type: Full-time
Category: Clinical Research
Remote: Fully Remote
Thermo Fisher Scientific’s Clinical Research Services team, part of the PPD® clinical research portfolio, drives innovation in clinical development by combining scientific excellence with operational expertise. The team plays a key role in bringing life-saving therapies to market and addressing the world’s most challenging health concerns.
Work Schedule: Standard (Monday – Friday)
Environmental Conditions: Office/Remote work
The Program Manager, Medical Writing leads high-visibility client programs, manages complex projects, and serves as the primary client liaison. This role ensures the timely delivery and quality of medical writing outputs, manages project timelines and budgets, and supports business development activities through proposal and contract management.
1. Program & Project Management
Develop, monitor, and adapt project plans, budgets, forecasts, and timelines for assigned programs.
Serve as the main point of contact between client and internal teams.
Manage multiple concurrent program deliverables to ensure quality and on-time delivery.
Identify, assess, and resolve project risks related to quality, budget, or schedule.
2. Client & Business Development
Lead client presentations and contribute to securing new business at the program level.
Prepare and review proposal texts, budgets, and contract modifications.
Build and maintain long-term client relationships through proactive communication and problem-solving.
3. Quality & Compliance
Ensure all deliverables comply with internal and regulatory quality standards.
Oversee document consistency and adherence to global guidelines and templates.
Develop and monitor performance metrics to assess program progress and quality outcomes.
4. Leadership & Mentorship
Provide guidance and training to medical writers on program management and technical writing processes.
Serve as a subject matter expert (SME) in assigned therapeutic or regulatory areas.
May act as a backup Medical Writer, contributing to writing and reviewing clinical and regulatory documents (e.g., CSRs, protocols, IBs, INDs, MAAs).
Education & Experience
Bachelor’s degree in a scientific discipline (advanced degree preferred).
8+ years of relevant experience in medical writing and program management within clinical research or CRO/pharmaceutical environments.
Proven experience in managing complex medical writing projects.
Certifications such as AMWA, EMWA, or RAC are advantageous.
Equivalent combinations of education, training, and directly related experience will be considered.
Strong program management skills, including budgeting, forecasting, and resource planning.
Extensive knowledge of global, regional, and national medical writing guidelines and documentation standards.
Expertise in one or more specialized areas (e.g., regulatory submissions, therapeutic areas, preclinical documentation).
Excellent communication, presentation, and interpersonal skills.
Strong negotiation and client management capabilities.
Self-motivated, adaptable, and capable of independent decision-making.
Proven leadership and mentoring skills for junior staff.
Thermo Fisher Scientific is committed to ensuring reasonable accommodation for individuals with disabilities during the application process, interview, and employment. Applicants requiring assistance can contact the company to request accommodation.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination on any legally protected basis, including race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected characteristic.
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