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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 Type: Full-Time
Category: Clinical Research
Work Model: Fully Remote
Experience Required: Minimum 5+ years


About the Role

PPD Clinical Research Services, part of Thermo Fisher Scientific, is expanding its India-based Medical Writing FSP Team and is seeking an experienced Senior Medical Writer (APAC region). This position offers the opportunity to work on global clinical research projects, supporting a leading client in the functional service provider (FSP) model. Experience in Immunology, Oncology, or Vaccines is preferred but not mandatory.

The role focuses on delivering high-quality scientific and clinical documentation from planning to final submission. You will collaborate with cross-functional global teams to enable clear, accurate, and compliant scientific communication.


Key Responsibilities

  • Serve as the primary author for client-assigned documents such as Clinical Study Reports (CSRs), Study Protocols, and related clinical documents.

  • Research, write, or edit complex regulatory and scientific documents, including IBs, INDs, MAAs, and program-level documentation.

  • Review documents developed by junior medical writers and provide guidance, mentorship, and training.

  • Ensure document quality, accuracy, formatting standards, and full compliance with regulatory and organizational guidelines.

  • Contribute to best practices, writing methodologies, and process optimization within FSP operations.

  • Support program management tasks, including tracking timelines, identifying out-of-scope activities, and preparing budget or contract-related inputs.

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


Education and Experience Requirements

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

  • Minimum 5+ years of relevant medical writing experience, preferably within a 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

  • Expertise in clinical/scientific data interpretation and regulatory writing.

  • Strong command of English with exceptional writing, editing, and proofreading skills.

  • Advanced understanding of global clinical document guidelines and regulatory expectations.

  • Ability to manage multiple projects, meet deadlines, and work independently in a remote environment.

  • Strong interpersonal skills, problem-solving capability, and negotiation skills.

  • Proficiency in document management systems, client templates, MS Office tools, and relevant writing applications.

  • In-depth knowledge in specialized therapeutic or regulatory areas is an added advantage.


What You Will Gain

PPD Clinical Research Services offers a collaborative, growth-oriented global environment, supported by:

  • A competitive salary and comprehensive benefits package.

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

  • Award-winning learning and development programs to enhance your professional growth.

  • Opportunities to contribute to global clinical research that advances public health.

Join Thermo Fisher Scientific’s mission-driven organization dedicated to making the world healthier, cleaner, and safer.


Apply Now

Become part of a global team committed to scientific excellence and advancing clinical research.
Start your story with PPD Clinical Research Services, a division of Thermo Fisher Scientific.