Ensure that adequate product portfolio information tools and databases are used, the ones that are appropriately designed and optimized for critical functional and management updates on local and global basis.
Responsible for the quality, coordination, medical accuracy, and timeliness of clinical study reports, responses to clinical questions from Health Authorities or IRBs related to sponsored studies within EDSI, and other documents for external or internal audiences related to EDSI sponsored studies.
Oversight of all processes that lead to the production of safety sections and content of relevant clinical trial documents including protocols, investigator brochures, informed consent forms, clinical study reports .
Oversees PV operations to ensure quality of reporting and compliance with safety regulations. This includes supervision of the three PV operations sub-functions, facilitation of interactions within CSPV and other departments (locally and globally), and coordination of collaboration with other vendors and license partners.
The Executive Director of Compensation will have responsibility for providing strategic and operational leadership for the compensation function. The new Executive Director will define and develop the strategic vision for global compensation that supports the business strategy and objectives.
Manage interactions with marketing, legal, medical affairs and marketing communication and other departments (R&D, etc.) to anticipate issues and provide guidance and solutions to the PRC team. Experience in DTC and social media.
The Project Leader is accountable to governance committees for the establishment and execution of a global integrated development strategy for the molecule which includes scientific rationale, clinical development, regulatory and technical strategy, and a franchise plan that optimizes program value and is aligned with corporate business objectives.
Coach, guide and manage all team members and franchise/functional work streams: Ensure operations team focuses on critical business questions, drives towards strategic and synthesized insights, and suggests ideas and recommendations that enable better decision-making for the business.