Senior Medical Writer II – Clinical & Regulatory Writing
Location: India (Remote / Hybrid)
Job Type: Full-Time
Experience Required: 6+ years in clinical and regulatory medical writing
Job Requisition ID: JR 7810
Date Posted: 6 Days Ago
About ProPharma
For over 20 years, ProPharma Group has empowered pharmaceutical, biotech, and medical device organizations worldwide to advance scientific breakthroughs confidently. We deliver end-to-end consulting solutions across the complete product lifecycle, spanning regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology. Our mission is to de-risk and accelerate high-profile drug and device programs while supporting innovation that improves patient health and wellness globally.
Role Overview
As a Senior Medical Writer II, you will author, review, and edit high-quality clinical, regulatory, and medical writing deliverables across all phases of clinical development. You will interact with cross-functional teams including clinical operations, data management, biostatistics, and regulatory affairs to produce accurate, compliant, and publication-ready documents. This role also includes mentoring junior writers, managing deliverable timelines, and maintaining adherence to global regulatory standards.
This position is ideal for a medical writing professional with strong clinical, regulatory, and device writing experience, excellent project management skills, and the ability to work independently in a remote or hybrid environment.
Key Responsibilities
Author, edit, and finalize clinical and regulatory documents including protocols, protocol amendments, study reports, patient narratives, investigator brochures, informed consent forms, clinical evaluation reports (CERs/CEPs), DSURs, PBRERs, IND/NDA/BLA/MAA submissions, eCTD modules, and plain language summaries
Mentor and train junior medical writers, providing guidance on scientific content, style, and regulatory compliance
Ensure all documents comply with ICH E3/E6(R2), EU MDR/IVDR, GCP, and company/client SOPs and templates
Manage client expectations, coordinate meetings, and lead project discussions related to timelines, deliverables, and document review cycles
Collaborate with subject matter experts to interpret clinical and statistical data accurately
Conduct QC reviews, maintain audit trails, and verify consistency, grammar, and formatting in documents
Review statistical analysis plans, table/figure/listing shells, and ensure alignment with protocols
Maintain awareness of current industry practices, regulatory requirements, and evolving medical writing guidelines
Work within budgeted hours and report any out-of-scope tasks to leadership
Manage multiple deliverables/projects simultaneously, prioritizing workloads and meeting deadlines
Contribute to departmental initiatives, process improvements, and knowledge sharing
Required Skills & Qualifications
6+ years of medical writing experience in clinical and/or regulatory documents for drugs, biologics, or medical devices/diagnostics
Bachelor’s degree or higher in a medical, scientific, or health-related discipline
Expertise in clinical research principles, including data interpretation and presentation
Advanced knowledge of regulatory submission requirements and guidelines (FDA, ICH, EU MDR/IVDR)
Strong command of MS Word, tables, graphs, figures, and document formatting
Excellent verbal and written communication skills in English, with proficiency in AMA style
Experience collaborating with cross-functional teams and managing client expectations
Proven ability to work independently, prioritize tasks, and meet strict timelines
Strong project management and organizational skills, with attention to detail and quality
Preferred Skills
Experience in complex regulatory submissions (e.g., PBRER, eCTD, IND, NDA, BLA, MAA)
Demonstrated leadership in mentoring or supervising junior writers
Familiarity with medical writing in global contract research organizations (CROs)
Ability to propose process improvements and innovative solutions for document management
Why Join ProPharma
Contribute to high-impact drug, biologic, and device programs globally
Work with a diverse and collaborative team across multiple therapeutic areas
Flexible remote or hybrid work options with opportunities for career growth and professional development
Inclusive culture fostering diversity, equity, and belonging
Opportunity to work on cutting-edge scientific, clinical, and regulatory projects
ProPharma is an Equal Opportunity Employer, committed to providing a workplace where all employees can thrive. Reasonable accommodations are available for candidates as needed.
SEO Keywords:
Senior Medical Writer India, Regulatory Medical Writing Jobs India, Clinical Writing Jobs CRO India, eCTD Medical Writer India, ProPharma Careers India
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