PHARMAFull-time
Manager, Medical Writing FSP
By Admin · Medical & Scientific Writing
REMOTE (IN)REMOTEPOSTED: 9/10/2026
PHARMAFull-time
HIRING ORGANIZATIONTHERMO FISHER SCIENTIFICLife Sciences / Scientific Instruments / Biotechnology
ROLE OVERVIEW
Lead medical writing operations for clinical research programs, managing writers, resources, deliverables, quality, timelines, training, and client-facing activities. The role combines scientific expertise, regulatory writing, people leadership, and clinical data interpretation within a global CRO environment.
ROLE DEFINITION & RESPONSIBILITIES
- •Supervise and mentor Medical Writers and manage workload allocation
- •Plan short-term and long-term resources, project timelines, costs, and staffing
- •Oversee preparation, review, and quality of medical writing deliverables
- •Provide guidance on study design, adverse event reporting, statistical analyses, and clinical data interpretation
- •Develop and review SOPs and WPDs and monitor compliance with departmental standards
- •Support client presentations, bid defenses, proposals, budgets, and business development activities
- •Develop and maintain Medical Writing training programs and ensure staff competency
- •Write and coordinate regulatory submission documents including IND, NDA, and CTD materials
Reporting Hierarchy: Reports to Medical Writing/Clinical Research leadership; supervises Medical Writers and collaborates with senior management, Bids and Contracts, Business Development, and clinical research functions
* 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, data interpretation, communication, and presentation skills
PREFERRED QUALIFICATIONS
- •Advanced degree such as PharmD, PhD, or Master's
- •Experience with pharmaceutical clinical research and regulatory submissions
- •Knowledge of ICH and FDA requirements
- •Experience with proposals, budgets, client presentations, audits, and bid defenses
REQUIRED VERIFIED SKILLS
Medical writing
clinical research
clinical data interpretation
regulatory writing
medical editing
proofreading
adverse event reporting
statistical analysis interpretation
ICH guidelines
FDA requirements
SOP
WPD
regulatory submissions
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Health and employee benefits, paid leave, retirement benefits, professional development and other company-standard benefits
No salary range or bonus/equity information is disclosed in the provided posting. Compensation should be confirmed directly with Thermo Fisher Scientific during recruitment.
ORGANIZATION CONTEXT & CULTURE
Thermo Fisher Scientific is a global scientific and life sciences company. Its PPD clinical research organization provides clinical research services supporting pharmaceutical and biotechnology companies in developing medicines.
TEAM SIZE: 100,000+ employees
INDUSTRY: Life Sciences / Scientific Instruments / Biotechnology
Culture: Science-driven, collaborative, innovation-focused environment emphasizing scientific excellence, professional development, operational quality, and meaningful contributions to healthcare.
EXPECTED CAREER ROADMAP
The position can progress into Senior Manager or Associate Director-level Medical Writing leadership, broader clinical development leadership, regulatory writing management, or client-facing clinical research operations roles.
APPLICATION ADVISORY
Highlight 5+ years of relevant experience and specifically quantify medical writing experience; demonstrate leadership of writers or clinical/scientific teams; showcase regulatory documents such as IND, NDA, and CTD; emphasize clinical data interpretation and knowledge of ICH/FDA requirements; provide examples of quality review, SOP/WPD compliance, resource planning, client presentations, and training; demonstrate strong editing and scientific communication skills.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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