PHARMAFull-time
Manager, Medical Writing FSP
REMOTE (IN)REMOTEPOSTED: 9/28/2026
PHARMAFull-time
HIRING ORGANIZATIONTHERMO FISHER SCIENTIFICLife Sciences / Scientific Instruments / Biotechnology
ROLE OVERVIEW
Lead Medical Writing operations by managing writers, allocating resources, overseeing clinical and regulatory deliverables, maintaining quality and compliance, supporting proposals and business development, and developing team training programs.
ROLE DEFINITION & RESPONSIBILITIES
- •Supervise and mentor Medical Writers and manage short- and long-term resource planning
- •Oversee preparation, quality, timeliness, and interpretation of Medical Writing deliverables
- •Review and maintain departmental SOPs and WPDs and monitor compliance
- •Provide expertise on study design, adverse-event reporting, statistical analyses, and clinical-data presentation
- •Prepare and review proposals, budgets, client presentations, and bid-defense materials with Business Development and Bids and Contracts
- •Develop and maintain Medical Writing training programs and ensure staff are adequately trained
- •Write and coordinate regulatory submission documents including IND, NDA, and CTD items
- •Support management reporting, workload forecasting, timelines, hiring, employee evaluation, promotions, and project-cost planning
Reporting Hierarchy: Leads and supervises Medical Writers within the Medical Writing function; interacts with senior management, Business Development, Bids and Contracts, clients, and regulatory-facing project teams
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree in a science-related field
- 5+ years of comparable relevant experience or equivalent combination of education, training, and experience
- At least 2 years of relevant Medical Writing experience, preferably in the pharmaceutical industry
- At least 1 year of leadership responsibility
- Excellent medical writing, editing, proofreading, and complex-data interpretation skills
PREFERRED QUALIFICATIONS
- •PharmD, PhD, or Master's degree
- •Experience with regulatory submission documents such as IND, NDA, and CTD
- •Experience with ICH and FDA guidelines
- •Experience in client presentations, bid defenses, proposals, and budgets
- •Experience developing Medical Writing training programs
REQUIRED VERIFIED SKILLS
Medical writing
clinical research
regulatory writing
medical editing
proofreading
clinical data interpretation
study design
adverse-event reporting
statistical analysis
ICH guidelines
FDA requirements
SOP
WPD
IND
NDA
CTD
resource planning
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Professional development, collaborative work environment, scientific innovation culture, and employee support programs; specific benefits are not stated in the supplied posting.
The supplied posting does not disclose salary, bonus, or equity. Compensation should be confirmed directly with Thermo Fisher Scientific; no figures are inferred.
ORGANIZATION CONTEXT & CULTURE
Thermo Fisher Scientific is a global scientific services and technology company. Its PPD clinical research organization provides clinical research services supporting pharmaceutical and biotechnology drug development programs.
TEAM SIZE: 120,000+ employees
INDUSTRY: Life Sciences / Scientific Instruments / Biotechnology
Culture: Thermo Fisher Scientific emphasizes scientific excellence, innovation, collaboration, and development while supporting clinical research programs that help advance medicines.
EXPECTED CAREER ROADMAP
Potential progression into Senior Manager or Associate Director/Director-level Medical Writing, clinical documentation, regulatory writing, or broader clinical research leadership roles depending on organizational opportunities and performance.
APPLICATION ADVISORY
Emphasize 5+ years of relevant experience, Medical Writing expertise, and at least 1 year of leadership responsibility; showcase regulatory documents such as IND/NDA/CTD, complex clinical-data interpretation, SOP/WPD development, ICH/FDA knowledge, resource planning, mentoring, and client-facing proposal or bid-defense experience.
RECOMMENDED TRAINING
1/5
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