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Fsp Senior Medical Writer (Apac)

5+ years
Not Disclosed
10 Oct. 8, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Position: FSP Senior Medical Writer (APAC)

Location: Remote, India
Job ID: R-01329712
Job Type: Full-time
Category: Clinical Research
Work Arrangement: Fully Remote


About the Role

At Thermo Fisher Scientific, your work contributes to making the world healthier, cleaner, and safer. As part of our PPD® clinical research portfolio, you’ll be at the forefront of advancing new therapies, conducting clinical trials in 100+ countries, and delivering impactful medical writing that supports life-changing drug development.

We are expanding our India Medical Writing FSP Team and seeking a Senior Medical Writer to support one of our global clients. Experience in Immunology, Oncology, or Vaccines is valuable but not essential. In this role, you’ll provide high-quality scientific and medical writing, manage end-to-end document delivery, and collaborate closely with clients to ensure operational excellence.


Work Schedule

  • Other / Flexible Schedule

Work Environment

  • Office (Remote Work)


Summarized Purpose

As a Senior Medical Writer (FSP), you will:

  • Serve as the primary author for client documents, ensuring accuracy, compliance, and clarity.

  • Deliver a variety of clinical and regulatory documents, including study protocols, CSRs, IBs, INDs, and MAAs.

  • Mentor junior writers, manage timelines, and contribute to process improvement initiatives.


Key Responsibilities

Medical Writing & Document Development

  • Serve as primary author for FSP client projects.

  • Write, review, and edit routine and complex clinical and regulatory documents, including:

    • Clinical Study Reports (CSRs)

    • Study Protocols

    • Investigator’s Brochures (IBs)

    • Investigational New Drug (IND) applications

    • Marketing Authorization Applications (MAAs)

  • Summarize and interpret clinical study data accurately.

  • Ensure all documents comply with regulatory standards, SOPs, and client-specific processes.

Review & Quality Oversight

  • Review documents prepared by junior writers and provide feedback.

  • Ensure quality, consistency, and compliance across all deliverables.

  • Participate in peer reviews and maintain best practice documentation.

Mentoring & Training

  • Provide training and mentorship to junior writers and project managers.

  • Guide team members in document development, use of software tools, and understanding regulatory requirements.

Project Management

  • Contribute to program management activities, including timelines, budgets, and forecasts.

  • Identify out-of-scope activities and manage change requests.

  • Represent the department at project launch meetings and client discussions.

Process Improvement

  • Independently develop and implement best practices, templates, and writing techniques.

  • Support continuous improvement initiatives to enhance writing quality and efficiency.


Education & Experience

Education

  • Bachelor’s degree in a scientific discipline required.

  • Advanced degree (Master’s/PhD) preferred.

  • Additional qualifications (e.g., AMWA, EMWA, RAC) are advantageous.

Experience

  • 5+ years of relevant medical writing experience.

  • Experience in the pharmaceutical or CRO industry preferred.

  • Prior experience working in FSP (Functional Service Provider) setups is desirable.


Knowledge, Skills & Abilities

  • Excellent medical writing, data interpretation, and editing skills.

  • Strong understanding of global and regional regulatory guidelines.

  • Proficient in project management and timeline adherence.

  • Skilled in problem-solving, negotiation, and stakeholder management.

  • Strong oral and written communication and presentation abilities.

  • Expertise in Microsoft Office Suite, document management systems, and client-specific templates.

  • Knowledge in specialty areas such as preclinical, regulatory submissions, or scientific communications is a plus.


What We Offer

  • Competitive salary and comprehensive benefits package focused on health and well-being.

  • Flexible work culture supporting work-life balance.

  • Access to an award-winning learning and development program for professional growth.

  • Collaborative, inclusive work environment with global exposure and a local team feel.

  • Opportunity to be part of a mission-driven organization with 100,000+ colleagues worldwide.


Our Mission & Values

At Thermo Fisher Scientific, we share a common mission:

To enable our customers to make the world healthier, cleaner, and safer.

We uphold core values of Integrity, Intensity, Innovation, and Involvement — working together to:

  • Accelerate scientific research,

  • Solve complex challenges,

  • Drive innovation, and

  • Support patients in need.

Join us and #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.

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