Responsible for Medical and External Affairs and will be part of the R&D leadership team. In addition, this position will closely partner with the Clinical Affairs and Regulatory departments in the design of clinical studies responsible for developing and executing the medical and external affairs strategy, overseeing the Medical Science Liaison team and the Advocacy/External Affairs function playing a lead role in the design of clinical trials and clinical development programs, in line with departmental and corporate goals. Works closely with other functions such as CMC, QA, Medical Affairs and Regulatory to ensure quality, timely and coordinated clinical study activities in compliance with the appropriate GCP/ICH and health authority guidelines. Plays a key role in supporting business development activities at Assertio.
Also responsible for executing and managing pharmacovigilance activities that include adverse event reporting, safety assessments, signal detection and aggregate reporting in compliance with applicable FDA and global regulations and Assertio standard operating procedures and guidelines.
Externally work with business partners to ensure execution of contracts that include, but are not limited to, safety vendor/s and companies.
Assist with the preparation of internal and external reports (e.g. PADERs) and production and distribution of routine pharmacovigilance metrics. Help drive internally, and collaborate with external partners, in the development and execution of risk management activities including Risk Evaluation and Mitigation Strategies (REMS) programs. Collaborates on projects and activities to support Assertio’s REMS programs.
Skills and Abilities