Medical Writer

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 per month

Benefits:

• Health insurance
• Paid sick time
• Provident Fund

Work Location: In person