Senior Medical Writer – Publication Writing
Location: Pune, Maharashtra, India
Job ID: 25104931
Employment Type: Full-Time
Experience Required: 3–5 years in medical or scientific writing, preferably in biopharmaceutical, device, or CRO settings
ThePharmaDaily.com presents a career opportunity for an experienced Senior Medical Writer with expertise in publication writing. This role is ideal for professionals with strong knowledge of FDA, ICH, and global regulatory guidelines, who can lead high-quality medical writing projects and publication deliverables across clinical studies.
About the Role
The Senior Medical Writer is responsible for creating, reviewing, and delivering scientific content that is clear, accurate, and aligned with regulatory and client requirements. This role involves managing medical writing activities for multiple studies, mentoring junior writers, and coordinating cross-functional collaboration with teams in data management, biostatistics, regulatory affairs, and medical affairs.
Key Responsibilities
Medical Writing & Publication Deliverables
Author and review a variety of documents, including:
Clinical Study Protocols and amendments
Clinical Study Reports (CSRs)
Patient Narratives and Investigator Brochures
Annual Reports and Development Safety Update Reports
Informed Consent Forms, Plain Language Summaries
IND, NDA, eCTD submissions, Integrated Summary Reports
Journal manuscripts, abstracts, posters, and scientific presentations
Conduct systematic literature searches and ensure compliance with copyright regulations
Analyze statistical outputs and review SAPs and TFLs for accuracy, grammar, and consistency
Coordinate peer and editorial reviews and manage source documentation
Regulatory Compliance & Quality Standards
Ensure adherence to ICH guidelines, FDA regulations, Good Publication Practices, and company SOPs
Maintain accuracy, clarity, and consistency across all written materials
Identify and propose solutions for project issues, escalating as necessary
Team Leadership & Mentorship
Mentor junior writers and provide guidance on complex projects
Contribute to training and process improvement initiatives
Provide peer review support for internal teams to maintain high-quality deliverables
Client & Cross-Functional Collaboration
Build strong working relationships with clients and internal teams
Collaborate with data management, biostatistics, regulatory affairs, and medical affairs teams
Communicate project timelines, status, and updates effectively
Project Management
Work within project budgets and timelines
Track project progress and report status to leadership
Manage multiple writing assignments while meeting deadlines
Qualifications & Skills
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field
3–5 years of experience in scientific, technical, or medical writing in pharmaceutical, biotechnology, or CRO environments
Strong understanding of FDA, ICH, and global regulatory guidelines
Extensive experience with publication writing and medical communications
Excellent command of English grammar and professional writing style
Familiarity with AMA Manual of Style preferred
Strong analytical, organizational, and communication skills
Work Environment
Office-based in Pune, with minimal travel (<25%) as required
Collaborative team-oriented environment with opportunities for professional development
Why This Role is Strategic
This position offers the opportunity to contribute to global clinical and regulatory documentation while leading publication projects that directly support the success of clinical trials and medical communications. The role combines scientific expertise, regulatory knowledge, and publication strategy to impact the delivery of high-quality, first-time-right medical writing outputs.
Discover More
Explore global careers in medical writing, regulatory affairs, pharmacovigilance, and clinical research at ThePharmaDaily.com.
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