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