Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Ensure activities maximize value and support GMA activities on time and in budget and in compliance with the Outsourcing, Purchasing and compliance process parameters.
Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
The Medical Director, Womens Health, Medical Affairs provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients, Prescribers, Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value).
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
The Group Medical Director is responsible for managing other Medical and/or Scientific Directors and leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs.
The Group Medical Director manages Medical and/or Scientific Directors and leads the direction, planning, execution and interpretation of clinical trials or research activities of one or more clinical development programs.
Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.