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Senior Medical Writer

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

Senior Medical Writer – Remote (India)

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


About the Role

We are seeking a highly skilled Senior Medical Writer to deliver high-quality scientific and clinical documentation that supports global clinical research programs. This role contributes to critical regulatory and clinical submission activities across multiple therapeutic areas and plays a vital part in ensuring clarity, accuracy, and compliance in all written content. You will collaborate with internal teams, external clients, and cross-functional stakeholders to drive operational excellence.

This opportunity is ideal for experienced medical writers looking to contribute to a leading global Contract Research Organization (CRO) with an extensive PPD® clinical research portfolio.


Key Responsibilities

  • Serve as the primary author for clinical study reports, study protocols, and data summaries for clinical trials.

  • Research, write, and edit complex scientific and regulatory documents including Investigator’s Brochures (IBs), Investigational New Drug Applications (INDs), and Marketing Authorization Applications (MAAs).

  • Review and provide feedback on documents authored by junior writers; offer ongoing training and mentorship on writing standards, regulatory guidelines, software usage, and document development.

  • Ensure all documents meet quality standards and comply with regulatory, client-specific, and internal requirements.

  • Contribute to the development of best practices, templates, and standardized processes for medical writing operations.

  • Support program management activities such as timeline planning, budgeting, forecasting, and identifying out-of-scope tasks.

  • Represent the medical writing function in study start-up meetings, project review meetings, and client discussions.


Education Requirements

  • Bachelor’s degree in a scientific discipline is required.

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


Experience Required

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

  • Experience with regulatory, clinical, and program-level document development is essential.

  • Certifications such as AMWA, EMWA, or RAC are advantageous but not mandatory.


Key Skills & Competencies

  • Strong proficiency in medical and scientific writing, including grammar, scientific communication, and editorial accuracy.

  • Excellent data interpretation skills and ability to translate complex scientific information into clear and concise documentation.

  • Strong project management capabilities with proven ability to handle multiple assignments and meet strict timelines.

  • Effective interpersonal skills, including problem-solving, negotiation, and collaboration with cross-functional teams.

  • Solid understanding of global and regional regulatory guidelines for clinical and regulatory document development.

  • In-depth knowledge of specialized areas such as regulatory submissions, therapeutic domains, or scientific communications.

  • Proficiency in document management systems, MS Office (Excel, Outlook), and client-specific templates.