לצערנו המשרה כבר לא בתוקף

GMA Excellence & Evidence Generation

3-4 שנים |
משרה מלאה
| 24/09/2020
תיאור משרה

Global strategic partner across therapeutic areas to support evidence generation within GMA. This role will support the tracking, processes and governance of GMA lead clinical studies, compassionate use programs and external research coordination and governance. Specific responsibility will include oversight of the external investigator initiated study (ISS) program and administration and execution of Internal Review Committee (IRC) meetings to review external requests or research support.
This position will be required to interact directly with internal and external stakeholders in order to ensure the timely execution of medical activities on time and on budget.

Represent GMA in the review and development of various procedural documents related to late-phase Global Medical Affairs studies and ISS, in alignment with the R&D GCO Systems and Standards, Specialty Clinical Development and GMA therapeutic area teams
Global study oversight and tracking for ISS, compassionate use programs, and support the oversight of CSS as required
Support the Global ISS program
Oversee Vendors to ensure accurate service delivery, required process or system updates and ensure continuous service/support
Act as support for regional and local Medical Affairs teams to assist with study start up activities in partnership with GCO and Procurement; e.g. SDC/protocol development, vendor selection, convene study team, MARC presentation
Development and refinement of relevant policies, SOP and Work Instructions
Work with internal stakeholders across regions, TAs and departments to facility successful processes for data generation including late phase study development and launch as well as Investigator Sponsored Studies programs
Provide support for GMA Excellence & Evidence Generation initiatives as requested

דרישות התפקיד

Bachelor’s degree in Biomedical Science and Pharmacy preferred
3 years in Medical Affairs experience
3 years of Clinical trial experience
Experienced and adept at working collaboratively across different cross-functional teams such as commercial, R&D, health outcomes, regulatory, pharmacovigilance and compliance/legal
Experienced and comfortable working in a matrix set up, facilitating desired outcomes by integrating business partners from various regions with different personal background
Limited regional and/or international travel travel – 10-15%