Job Description

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