Senior Medical Writer II – Clinical & Regulatory Writing
Location: India (Remote / Hybrid options available)
Employment Type: Full-Time
Requisition ID: JR 7810
Posted: 6 Days Ago
About ProPharma
For over 20 years, ProPharma has been a trusted global partner to biotechnology, pharmaceutical, and medical device organizations, supporting the advancement of innovative therapies and scientific breakthroughs. Operating through an advise–build–operate model, ProPharma delivers comprehensive, customizable consulting solutions across the full product lifecycle. The organization is recognized for deep expertise in regulatory sciences, clinical research, pharmacovigilance, medical information, quality & compliance, and R&D technology.
Role Overview
ProPharma is seeking an experienced Senior Medical Writer II to independently develop, review, and manage high-quality clinical, regulatory, and safety documents across multiple therapeutic areas. This role requires advanced expertise in global regulatory standards, strong project leadership skills, and the ability to collaborate effectively with cross-functional stakeholders while mentoring junior medical writers.
Key Responsibilities
Author, edit, and review complex medical writing deliverables across all phases of clinical development, including but not limited to:
Protocols, protocol amendments, clinical study reports (CSRs)
Patient narratives, Investigator’s Brochures (IBs), Informed Consent Forms (ICFs)
DSURs, PBRERs, plain language summaries
Regulatory submission documents such as INDs, NDAs, BLAs, MAAs, and eCTD modules
Ensure compliance with global regulatory standards and guidelines, including ICH E3/E6 (R2), FDA, EMA, EU MDR/IVDR, and internal SOPs
Lead and manage timelines, deliverables, and client communications with minimal supervision
Supervise, mentor, and provide peer review support to junior medical writers
Collaborate with clinical operations, biostatistics, data management, regulatory affairs, and other subject matter experts
Coordinate quality control (QC) reviews and maintain document audit trails
Review statistical analysis plans (SAPs) and TFL shells for accuracy and consistency
Support project management activities, including timeline tracking and client meetings
Proactively identify risks, inefficiencies, and quality concerns, proposing practical solutions
Stay current with evolving regulatory requirements, industry trends, and medical writing best practices
Contribute to departmental initiatives such as process improvements and knowledge-sharing sessions
Required Skills and Competencies
Advanced expertise in clinical research principles and interpretation of clinical data
Strong understanding of global regulatory submission processes and documentation requirements
Proficiency in MS Word, including advanced formatting of tables, figures, and graphs
Excellent written and verbal communication skills in English
Strong project management, organizational, and stakeholder management abilities
High attention to detail with a strong quality-driven mindset
Familiarity with AMA style and regulatory writing conventions
Ability to work independently while managing multiple projects simultaneously
Education & Experience Requirements
Bachelor’s degree or higher in a medical, life sciences, or scientific discipline
Minimum 6 years of hands-on experience in clinical and/or regulatory medical writing for pharmaceuticals, biologics, and/or medical devices
Experience within a CRO, pharmaceutical, biotechnology, or medical device organization is required
Equivalent professional or academic experience may be considered on a case-by-case basis
Work Environment & Culture
ProPharma is an Equal Opportunity Employer committed to diversity, equity, and inclusion. The organization fosters a collaborative, innovative, and growth-oriented environment where employees are empowered to succeed. While remote work is supported, hybrid working is encouraged for employees living within commuting distance of ProPharma offices to promote in-person collaboration.
Important Notice
ProPharma Group does not accept unsolicited resumes from recruitment agencies or third parties. All applications are reviewed by the recruitment team, and candidates will receive direct communication regarding application outcomes.
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