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Fsp Senior Medical Writer (Apac

5+ 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 Senior Medical Writer (APAC) – Remote, India

Company: PPD Clinical Research Services, part of Thermo Fisher Scientific
Location: Remote, India
Job ID: R-01329712
Job Type: Full-Time
Category: Clinical Research
Work Model: Fully Remote
Experience Required: Minimum 5+ years


About the Role

PPD Clinical Research Services, a global CRO under Thermo Fisher Scientific, is seeking an experienced Senior Medical Writer (APAC region) to support its expanding Medical Writing FSP Team in India. This role involves delivering high-quality scientific and clinical documentation for global clients, with a focus on operational excellence and regulatory compliance. Experience in Immunology, Oncology, or Vaccines is preferred but not mandatory.

This position offers the opportunity to work with international teams across 100+ countries, supporting impactful research that advances global health.


Key Responsibilities

  • Act as the primary author for key clinical documents including Clinical Study Reports (CSRs), Study Protocols, and summaries of study data.

  • Write, research, or edit complex scientific documents such as Protocols, IBs, INDs, MAAs, and other regulatory submissions.

  • Review documents prepared by junior writers and provide mentorship, training, and guidance on writing processes, therapeutic areas, and regulatory requirements.

  • Ensure all assigned documents adhere to quality standards, regulatory guidelines, and client-specific expectations.

  • Contribute to the development of best practices, process improvements, and documentation standards within FSP operations.

  • Support program management tasks such as timeline development, budget inputs, scope assessments, and contract-related activities.

  • Represent Medical Writing at project launch meetings, review calls, and cross-functional meetings.


Education and Experience Requirements

  • Bachelor’s degree in a scientific discipline; Master’s or advanced degree preferred.

  • Minimum 5+ years of medical writing experience in the pharmaceutical, CRO, or FSP environment.

  • Additional certifications such as AMWA, EMWA, RAC are advantageous.

  • Equivalent combinations of education, training, and experience may be considered.


Skills and Competencies

  • Strong expertise in medical writing, data interpretation, and scientific communication.

  • Excellent editorial, grammatical, and proofreading abilities.

  • Strong project management, problem-solving, and negotiation skills.

  • Effective interpersonal communication and presentation skills.

  • Comprehensive knowledge of global, regional, and national document development guidelines.

  • Advanced understanding of therapeutic areas, regulatory submissions, and clinical documentation.

  • Proficiency with Microsoft Office tools, document management systems, and client-specific templates.

  • Demonstrated ability to work independently, manage timelines, and deliver high-quality outputs.


What We Offer

PPD Clinical Research Services provides an inclusive, growth-focused environment with:

  • Competitive salary and comprehensive employee benefits.

  • Flexible remote working culture and excellent work-life balance.

  • Award-winning training and learning programs to support career advancement.

  • A collaborative global environment with strong team support and knowledge sharing.

  • Opportunities to contribute to research that makes the world healthier, cleaner, and safer.

As part of Thermo Fisher Scientific’s global network of 100,000+ professionals, you will contribute to meaningful scientific innovation and impactful healthcare solutions.


Apply Now

Advance your career in global medical writing with a leading CRO.
Start your journey with PPD Clinical Research Services, a division of Thermo Fisher Scientific, and play a key role in shaping the future of clinical research.