PHARMAFull-time
Manager, Medical Writing FSP
REMOTE (IN)REMOTEPOSTED: 9/19/2026
PHARMAFull-time
HIRING ORGANIZATIONTHERMO FISHER SCIENTIFICLife Sciences / Scientific Instruments / Biotechnology
ROLE OVERVIEW
Manager, Medical Writing FSP leading Medical Writers, resource planning, clinical document delivery, quality review, regulatory writing, training, and client-facing Medical Writing activities within a global clinical research organization.
ROLE DEFINITION & RESPONSIBILITIES
- •Supervise, evaluate, mentor, and manage Medical Writers
- •Plan short-term and long-term resources and allocate projects
- •Oversee preparation, quality, and timely completion of Medical Writing deliverables
- •Provide guidance on study design, adverse event reporting, statistical analyses, and clinical data interpretation
- •Perform senior reviews and support development and compliance of SOPs and WPDs
- •Present Medical Writing capabilities to potential clients and support bids, proposals, and budgets
- •Develop and maintain Medical Writing training programs
- •Write and coordinate regulatory submission documents including IND, NDA, and CTD items
Reporting Hierarchy: Manages and mentors Medical Writers and provides updates to senior management; Collaborates with Bids and Contracts, Business Development, and clinical research stakeholders; Specific reporting manager and team size are not stated
* 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, grammar, editorial, proofreading, communication, and data interpretation skills
PREFERRED QUALIFICATIONS
- •Advanced degree such as PharmD, PhD, or Master's
- •Experience with regulatory submission documents
- •Knowledge of ICH and FDA requirements
- •Experience with client presentations, bid defenses, proposals, and budgets
- •Experience developing departmental processes and training programs
REQUIRED VERIFIED SKILLS
Medical Writing
Clinical Research
Regulatory Writing
Medical Communications
Clinical Data Interpretation
Adverse Event Reporting
Statistical Analysis Interpretation
SOP
WPD
ICH Guidelines
FDA Requirements
IND
NDA
CTD
Proposal Development
Budgeting
Resource Planning
Team Leadership
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Global contract research and clinical research benefits, learning and development opportunities, and employee support programs; specific benefits are not disclosed in the provided posting.
No salary or numerical compensation is disclosed in the provided posting, so no compensation figure is inferred.
ORGANIZATION CONTEXT & CULTURE
Thermo Fisher Scientific is a global scientific and healthcare company providing products, services, technologies, and clinical research capabilities to support scientific discovery, diagnostics, and pharmaceutical development.
TEAM SIZE: 120,000+ employees
INDUSTRY: Life Sciences / Scientific Instruments / Biotechnology
Culture: The posting emphasizes scientific excellence, collaboration, innovation, development, and operational impact within a global clinical research environment.
EXPECTED CAREER ROADMAP
This management role can progress toward Senior Medical Writing leadership, Associate Director or Director-level Medical Writing, regulatory writing leadership, scientific communications leadership, or broader clinical research operations management.
APPLICATION ADVISORY
Highlight 5+ years of relevant experience and at least 2 years of medical writing experience; clearly demonstrate leadership or people-management experience; showcase regulatory writing exposure including IND, NDA, or CTD documents; emphasize senior review, clinical data interpretation, SOP/WPD compliance, and ICH/FDA knowledge; demonstrate client-facing presentation, proposal, budget, and resource-planning experience.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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