Aggregate Reporting

Roles & Responsibilities:-

• Experience in medical writing domain across different therapeutic areas in clinical documents including protocol, informed consent document, clinical study report, investigator's brochure, clinical summary of pharmacology, clinical overview (efficacy and safety); and/or safety documents like Development safety update report (DSUR), Periodic benefit risk evaluation report (PBRER), Risk Management Plans (RMPs), addendum to clinical overviews (aCOs)
• Experience in preparation of clinical/safety documents necessary for national and international regulatory submissions to the US, European and other regulatory agencies preferred
• Experience in writing and review of scientific/clinical documents preferred
• Knowledge of clinical research domain, ICH GCP principles and regulatory requirements preferred
• Effective coordination and presentation skills - Good organization and time management skills
• Exceptional interpersonal, verbal and written communication skills