Senior Medical Writer II (Clinical & Regulatory) – Remote India | ProPharma Careers
About ProPharma
ProPharma is a leading global consulting organization with over two decades of experience supporting biotech, pharmaceutical, and medical device companies. Through its advise-build-operate model, ProPharma partners with clients across the entire product lifecycle to accelerate drug development, ensure regulatory compliance, and improve patient outcomes. The company offers specialized expertise in regulatory sciences, clinical research, pharmacovigilance, medical information, quality and compliance, and R&D technology.
Job Overview
ProPharma is seeking an experienced Senior Medical Writer II to deliver high-quality clinical, regulatory, and safety documentation. This role involves end-to-end medical writing support across multiple therapeutic areas and phases of clinical development. The ideal candidate will demonstrate strong scientific writing expertise, project ownership, and the ability to collaborate with cross-functional stakeholders and global clients.
Key Responsibilities
Author and edit high-quality medical writing deliverables, including:
Clinical study protocols and amendments
Clinical study reports (CSRs)
Investigator Brochures (IBs) and Informed Consent Forms (ICFs)
Patient narratives and plain language summaries
Clinical Evaluation Plans/Reports (CEP/CER)
DSURs, PBRERs, INDs, NDAs, BLAs, MAAs, and eCTD submissions
Manage complex regulatory and submission-level documents with minimal supervision
Lead client communication, including project kickoff meetings, timelines, and deliverable reviews
Collaborate with cross-functional teams (clinical operations, biostatistics, regulatory affairs, data management)
Supervise, mentor, and support junior medical writers
Ensure compliance with global regulatory guidelines (ICH E3/E6(R2), FDA, EU MDR/IVDR) and company SOPs
Coordinate quality control (QC) reviews and maintain document audit trails
Review statistical analysis plans and data presentation formats (tables, figures, listings)
Perform peer reviews and QC checks as required
Manage multiple projects simultaneously, ensuring on-time and within-budget delivery
Support process improvement initiatives and departmental activities
Required Skills and Competencies
Advanced expertise in clinical research and regulatory medical writing
Strong understanding of global regulatory requirements (FDA, EMA, ICH guidelines)
Proven ability to interpret and present complex clinical and scientific data
Excellent project management and organizational skills
Advanced proficiency in MS Word, including tables, graphs, and formatting for regulatory submissions
Strong communication and stakeholder management skills
Familiarity with AMA (American Medical Association) writing style
Ability to work independently and in cross-functional global teams
High attention to detail with a quality-driven mindset
Proactive problem-solving and continuous improvement approach
Educational Qualifications
Bachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, or a related scientific discipline
Advanced degrees are preferred
Experience Requirements
Minimum: 6+ years of experience in medical writing (clinical and/or regulatory)
Freshers: Not eligible for this role
Prior experience in a Contract Research Organization (CRO), pharmaceutical, or biotechnology company is required
Hands-on experience with regulatory submissions (IND, NDA, BLA, MAA) is highly preferred
Work Model
Remote role based in India
Hybrid work encouraged for candidates near ProPharma office locations
Why Join ProPharma
Opportunity to work on global clinical and regulatory projects
Exposure to diverse therapeutic areas and advanced scientific developments
Collaborative, inclusive, and innovation-driven work culture
Career growth through mentorship and leadership opportunities
Diversity, Equity, and Inclusion
ProPharma is committed to building an inclusive workplace where diversity is valued and every employee is empowered to succeed. The organization fosters a culture of collaboration, innovation, and equal opportunity for all.
Application Process
All applications are reviewed by ProPharma’s recruitment team. The company ensures a transparent hiring process and provides feedback to all applicants. ProPharma does not rely on AI-based screening tools.
Important Notice
ProPharma does not accept unsolicited resumes from third-party recruiters. Direct outreach regarding this role is not encouraged.
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