This role will lead cross-functional teams from multiple sites, and external partners, to support development and manufacturing of innovative medical device products and/or devices that are integrated with biologics to create combination drug/device products.
The Epic Project Director is responsible for the successful planning and execution of a multi-year, multi-facility, enterprise-wide clinical and revenue cycle systems implementation for a major Impact Advisors Epic client.
Lead the global submission planning process, including potential Advisory Committees. Lead regulatory submission process throughout project lifecycle on behalf of GPT. This includes oversight of submission plan, generation and sign-off of key regulatory/response components.
this role will lead cross-functional teams from multiple Integra sites, and external partners, to support development and manufacturing of innovative medical device products and/or devices that are integrated with biologics to create combination drug/device products.
The Sr. Manager/Associate Director, Program Management will provide project management oversight and support for key functional teams of the Global Medical Affairs organization at Intercept in support of the Director, Program Management (Global Medical Affairs).
Manage a team of Project Managers utilizing performance metrics and escalation processes to ensure the handling of projects meets or exceeds service level agreements and stakeholder standards and expectations.
Responsibilities will include leading and managing the Launch Readiness operational activities, including developing and maintaining high performing teams, ensuring alignment between project and program strategies and plans, generating high quality global strategic integrated project plans, risk management and communication plans.
Responsible for continuous evaluation of drug safety profile, including the aspects of relevance to patients in clinical studies, as well as external stake holders (e.g., health authorities) with support from Drug Safety & Epidemiology.
Effectively facilitates and manages team meetings and assures that proper communication regarding the project is appropriately elevated and distributed (including presenting at key project stage and other reviews).