_Responsibilities for medical writer_
- Knowledgeable of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions
- Understands, assimilates, and productively interprets sources of information, with appropriate guidance/direction from product teams and/or authors
- Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings and dossiers
- Manages all aspects of the medical writing processes for document development including, quality check, scheduling/timeline management, driving document preparation, coordinating document reviews and revisions, maintaining version control, and coordinating final reviews and approval
- Represents Medical Writing and Clinical Biometrics on cross-functional teams
- Develops, edits and reviews regulatory documents within agreed timelines that have high quality scientific content, organization, clarity, accuracy, format and consistency
- Stays current on medical writing best practices and regulatory guidelines




- Documenting study-specific Protocol Training (Kick-off Meeting Slides, Protocol Overview Presentations, ) by filling out and collecting signatures on group training forms as required
- Write, review, and edit clinical regulatory documents such as clinical study protocols, clinical study reports (CSRs), Investigator’s Brochures, and other documents as required for submissions
- Interpret statistical and clinical data with appropriate guidance/direction from teams and management
- Qualifications for medical writer_
- Advanced Scientific Degree (MSc., Ph.D., PharmD)
- Familiarity with medical terminology and clinical trial design (theoretical knowledge is sufficient)
- Familiarity with some reference manager software (EndNote, Reference Manager, Mendeley, Citavi)
- Excellent time and project management skills, team working skills

Job Types: Full time, Permanent, Fresher

Pay: ₹28,883.49 - ₹50,111.00 pe

📌 Medical Writer (Pune)
🏢 Statistical Pharma
📍 Pune