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Senior Medical Writer

Thermo Fisher Scientific
Thermo Fisher Scientific
5+ years
preferred by company
10 Feb. 2, 2026
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

Senior Medical Writer – Clinical Research (Fully Remote, India)

Job ID: R-01332283
Job Type: Full Time
Category: Clinical Research / Medical Writing
Work Mode: Fully Remote
Location: India
Work Schedule: Monday to Friday (Standard Business Hours)


About the Role

We are seeking an experienced Senior Medical Writer to support global clinical research programs within a leading Contract Research Organization (CRO). This role is critical to the planning, development, review, and delivery of high-quality medical and scientific documents that support clinical development, regulatory submissions, and client communications.

As a Senior Medical Writer, you will serve as a primary author for key clinical documents, collaborate with cross-functional stakeholders, ensure regulatory compliance, and contribute to process excellence across projects. You may also support program management activities and mentor junior writers.


Key Responsibilities

  • Lead the end-to-end development of medical and scientific documents from planning through final delivery for internal and external clients.

  • Serve as primary author for routine clinical documents, including Clinical Study Reports (CSRs), study protocols, and related summaries.

  • Research, write, and edit complex clinical and regulatory documents such as Investigator’s Brochures (IBs), INDs, MAAs, and other program-level deliverables.

  • Interpret and summarize clinical data accurately and clearly for scientific and regulatory audiences.

  • Review documents prepared by junior medical writers to ensure quality, consistency, and compliance.

  • Provide guidance, training, and mentorship to junior writers and support program managers on document development processes and regulatory requirements.

  • Ensure all assigned documents comply with global, regional, and country-specific regulatory guidelines and internal quality standards.

  • Contribute to the development and continuous improvement of best practices, templates, and client-specific writing processes.

  • Support program management activities, including identifying and resolving out-of-scope work, assisting with timelines, budgets, forecasts, and contract modifications.

  • Represent the medical writing function in project launch meetings, team reviews, and cross-functional discussions.


Education and Experience Requirements

  • Bachelor’s degree in a scientific discipline (Life Sciences, Pharmacy, Medicine, or related field); an advanced degree is preferred.

  • Minimum 5+ years of experience in medical writing within the pharmaceutical, biotechnology, or CRO industry.

  • Demonstrated experience authoring clinical and regulatory documents across multiple study phases.

  • Prior experience working in a global CRO or regulated clinical research environment is strongly preferred.

  • Professional certifications in medical writing or regulatory affairs (AMWA, EMWA, RAC) are advantageous.

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


Required Knowledge, Skills, and Competencies

  • Strong medical and scientific writing skills, including data interpretation, editing, and proofreading.

  • Excellent understanding of global document development standards and regulatory guidelines.

  • In-depth knowledge in one or more specialty areas such as clinical development, regulatory submissions, therapeutic areas, or scientific communications.

  • Strong project management and organizational skills with the ability to manage multiple deliverables.

  • Excellent written and verbal communication skills, including presentation and stakeholder engagement.

  • Sound judgment, decision-making, and problem-solving abilities.

  • Proficiency in document authoring tools, client templates, and document management systems.

  • Strong computer skills, including Microsoft Word, Excel, Outlook, and related applications.

  • Ability to work independently in a remote environment while collaborating effectively with global teams.


Why Join Us

  • Work on global clinical development programs that contribute to bringing innovative therapies to market.

  • Gain exposure to complex regulatory and scientific writing projects across multiple therapeutic areas.

  • Collaborate with experienced clinical research professionals in a quality-driven, compliant environment.

  • Benefit from continuous learning, mentorship, and long-term career growth opportunities in medical writing and clinical research.

  • Enjoy the flexibility of a fully remote role while contributing to high-impact global studies.