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Senior Medical Writer

5+ years
Not Disclosed
10 Nov. 7, 2025
Job Description
Job Type: Full Time Remote 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 Title: Senior Medical Writer

Location: Remote, India
Job ID: R-01332283
Job Type: Full-Time
Category: Clinical Research
Work Arrangement: Fully Remote
Work Schedule: Standard (Mon–Fri)
Environment: Office


Company Overview

Our Clinical Research Services team plays a crucial role in accelerating the delivery of life-saving therapies to market. As part of the PPD® clinical research portfolio within a leading global Contract Research Organization (CRO), we combine scientific rigor with clinical excellence to tackle the world’s most challenging health issues.


Purpose of the Role

The Senior Medical Writer delivers high-quality medical and scientific documents from planning through to final delivery, ensuring clarity, compliance, and scientific accuracy. The role involves collaboration with internal and external clients, mentorship of junior staff, and support for program management activities when required.


Key Responsibilities

Medical & Scientific Writing

  • Serve as primary author for documents such as clinical study reports (CSRs), study protocols, and other regulatory or clinical documents.

  • Research, write, and edit complex scientific documents (e.g., Investigator’s Brochures [IBs], Investigational New Drug applications [INDs], Marketing Authorization Applications [MAAs]).

  • Summarize and interpret clinical data accurately and effectively for both technical and non-technical audiences.

Review & Mentorship

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

  • Provide training and mentorship on writing standards, regulatory requirements, and therapeutic area content.

  • Guide team members on document development tools and client-specific processes.

Quality & Compliance

  • Ensure all deliverables comply with company and client quality processes.

  • Contribute to the development of best practices, templates, and documentation standards to improve efficiency.

Program & Project Management

  • Support program management activities, including timeline development, budget forecasting, and contract modifications.

  • Participate in project launch, review, and team meetings as a departmental representative.

  • Identify and resolve out-of-scope activities effectively.


Qualifications

Education & Experience

  • Bachelor’s degree in a scientific discipline or equivalent qualification required.

  • Advanced degree (Master’s/Ph.D.) preferred.

  • Minimum 5+ years of experience in medical writing or related scientific communication.

  • Experience in the pharmaceutical or CRO industry preferred.

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

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


Knowledge, Skills, and Abilities

  • Exceptional medical writing, data interpretation, and editorial skills.

  • Strong project management and organizational capabilities.

  • Proficiency in grammar, proofreading, and document formatting.

  • Excellent oral and written communication and presentation skills.

  • Strong negotiation, problem-solving, and decision-making abilities.

  • In-depth understanding of global, regional, and national regulatory guidelines.

  • Specialized knowledge in one or more areas such as preclinical research, therapeutic areas, or regulatory submissions.

  • Proficient in Microsoft Office Suite (Excel, Outlook) and document management systems.

  • Skilled in adapting to client-specific templates and documentation standards.