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Fsp Medical Writing Program Manager (Remote – India)

8+ years
Not Disclosed
10 Nov. 25, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

FSP Medical Writing Program Manager (Remote – India)

Location: Remote, India
Job Type: Full-Time
Category: Clinical Research
Work Model: Fully Remote

Overview

Thepharmadaily.com is pleased to feature this career opportunity for an experienced FSP Medical Writing Program Manager based in India. This role supports Thermo Fisher Scientific’s global clinical research operations, contributing to high-quality scientific documentation that accelerates drug development and improves patient outcomes. The position offers remote flexibility while being part of a world-leading CRO environment.

About the Role

As an essential member of the Medical Writing FSP Team, the Program Manager will oversee large-scale narrative programs, ensure high-quality documentation, and lead cross-functional communication. The role requires strong experience in managing complex medical writing projects, guiding writing teams, and working directly with clients in the pharmaceutical or CRO domain.

Key Responsibilities

  • Develop, manage, and adjust program-level project plans, timelines, and budget forecasts.

  • Serve as the primary escalation point for project-related risks, ensuring quality, budget, and delivery timelines are met.

  • Maintain strict compliance with global document development standards and internal quality processes.

  • Monitor performance metrics and ensure alignment across multiple project documents.

  • Provide senior-level quality review and oversight of medical writing deliverables.

  • Train, mentor, and guide medical writers in program processes and writing standards.

  • Contribute as a primary author for study-level and program-level regulatory documents when required.

Required Experience

  • Minimum 8+ years of relevant medical writing and program management experience in the pharmaceutical, biotechnology, or CRO industry.

  • Proven track record of managing large-scale narrative or multi-writer medical writing projects.

  • Strong background in scientific communication, regulatory documentation, and cross-functional collaboration.

  • Experience mentoring and leading writing teams is highly desirable.

  • Additional certification in medical writing (AMWA, EMWA, RAC) is an advantage.

Education

  • Bachelor’s degree in a scientific discipline required.

  • Master’s degree or advanced scientific qualifications preferred.

Skills and Competencies

  • Expertise in project management, resource planning, and timeline oversight for multi-author projects.

  • Excellent medical writing, data interpretation, grammatical and editorial skills.

  • In-depth knowledge of global and regional regulatory document guidelines.

  • Strong communication and presentation capabilities.

  • Effective negotiation, decision-making, and problem-solving abilities.

  • Ability to mentor, guide, and support entry-level writers and team members.

  • High level of independence, adaptability, and professional judgment.

What the Organization Offers

  • Competitive compensation structure aligned with industry standards.

  • Comprehensive benefits package designed to support well-being and work-life balance.

  • Access to award-winning learning and development programs for career growth.

  • Collaborative, global working environment with a strong culture of integrity, innovation, and scientific excellence.

  • Opportunity to contribute to meaningful clinical research impacting global health.