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Manager, Medical Writing – Fsp

Thermo Fisher Scientific
Thermo Fisher Scientific
5+ years
preferred by company
Remote, India, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes

Manager, Medical Writing – FSP

Location: Remote, India
Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Job Type: Full-Time
Work Mode: Fully Remote
Industry: Medical Writing | Clinical Research | Regulatory Writing | CRO | Pharmaceutical
Department: Clinical Research Services / Medical Writing / Functional Service Partnerships (FSP)
Job Reference ID: R-01349882
Work Schedule: Monday to Friday

Job Overview

Thermo Fisher Scientific is hiring a Manager, Medical Writing – FSP for its PPD Clinical Research Services division in India. This fully remote leadership opportunity is ideal for experienced professionals with expertise in medical writing, regulatory documentation, clinical research writing, scientific communication, team leadership, resource planning, and pharmaceutical submission documentation.

The selected candidate will lead a team of medical writers, oversee high-quality medical writing deliverables, manage operational workflows, support regulatory submission documentation, mentor teams, and contribute to business development within a global CRO environment.

This role is ideal for professionals seeking leadership growth in medical writing management, regulatory medical communications, CRO delivery leadership, and pharmaceutical documentation strategy.

Job Responsibilities

Medical Writing Team Leadership

  • Lead and supervise a team of medical writers within the Functional Service Partnerships (FSP) model.
  • Manage:
    • Team performance
    • Workload allocation
    • Project assignments
    • Delivery oversight
    • Resource utilization
    • Team productivity

Support both short-term and long-term workforce planning.

Resource Planning & Workforce Management

  • Allocate projects based on writer expertise, availability, and project complexity.
  • Forecast:
    • Resource needs
    • Project timelines
    • Writing capacity
    • Delivery risks
    • Project-related costs

Ensure optimal operational efficiency.

Medical Writing Deliverables Oversight

Oversee preparation, review, and delivery of medical writing documents including:

  • Clinical study reports (CSRs)
  • Protocols
  • Investigator brochures
  • IND documentation
  • NDA submission documents
  • CTD modules
  • Regulatory submission content
  • Safety documentation
  • Scientific clinical summaries

Ensure quality, accuracy, and compliance.

Scientific Review & Quality Assurance

  • Perform senior-level review of medical writing deliverables.
  • Ensure adherence to:
    • Internal writing standards
    • SOPs
    • Work Practice Documents (WPDs)
    • Regulatory expectations
    • Quality requirements

Provide scientific guidance on data presentation and interpretation.

Regulatory Writing & Submission Support

Support preparation and review of regulatory documents for submission to agencies including:

  • FDA
  • ICH-compliant submissions
  • IND applications
  • NDA applications
  • CTD documentation
  • Clinical regulatory dossiers

Clinical Data Interpretation Support

  • Use clinical knowledge to guide scientific interpretation of:
    • Clinical trial data
    • Safety findings
    • Statistical outputs
    • Adverse event reporting
    • Study design documentation

Support writers in presenting complex data clearly and accurately.

SOP & Compliance Management

  • Develop, review, and maintain:
    • SOPs
    • WPDs
    • Departmental writing standards
    • Quality documentation frameworks

Monitor compliance with documentation standards.

Training & Capability Development

  • Build and maintain training programs for medical writing teams.
  • Ensure all writers receive adequate onboarding and ongoing capability development.
  • Mentor junior and mid-level writers.

Business Development Support

Participate in:

  • Client capability presentations
  • Proposal development
  • Budget discussions
  • Bid support
  • Contract discussions
  • Business development initiatives

Represent medical writing capabilities to prospective clients.

People Management

  • Conduct regular team meetings and performance discussions.
  • Review timesheets and workload management.
  • Support:
    • Hiring
    • Performance evaluations
    • Promotions
    • Compensation recommendations
    • Professional development planning

Educational Qualification

Candidates must have:

  • Bachelor’s Degree in a science-related discipline

Preferred:

  • PharmD
  • PhD
  • Master’s Degree
  • Pharmacy
  • Life Sciences
  • Biomedical Sciences
  • Clinical Research
  • Medicine-related backgrounds