At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our growing global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to approach science, manufacturing and commercialization. And new ways to think about health!
Manager, Medical Study Operations, Onco-Hematology - Munich
As a key member of the Medical Affairs team, you will serve as an important liaison between Regeneron and the scientific and healthcare community.
As Manager, Medical Study Operations (MSO) - you will be responsible for leading operational activities across assigned projects including study start-up activities, timelines, budgets and reports in support of Externally Sponsored Research (ESR) including Investigator-Initiated Studies Programs, Collaboration Studies, and Managed Access Programs, led by Medical Affairs, while ensuring compliance standards are met.
A typical day may include:
* Working collaboratively with medical directors and team members to ensure study(s) are on track according to timelines, issues are identified and escalated appropriately, and deliverables are clearly communicated.
* Managing study start-up, maintenance, and closeout of studies.
* Maintaining Essential Document - ensures all appropriate documentation in support of a proposal has been collected and filed correctly within the document repository systems on an ongoing basis.
* Coordinating Pharmacovigilance Compliance activities - IAL distribution and appropriate tracking of receipt and delivery, and/or SAE reconciliations.
* Managing Drug Supply, budget, metrics & reporting, meetings & committees & processes.
This role may be for you if:
* You enjoy working autonomously in the field while making an impact on the company's mission.
* You can communicate and act promptly, demonstrating initiative, creativity, and efficiency in sophisticated, rapidly changing environments.
* You have good knowledge in managing IIT studies within the field of Onco-Hematology.
* You enjoy collaborating with the team and establishing relationships with internal & external partners.
* You can lead multiple initiatives, prioritize them, and implement them independently.
To be considered for this role, you must hold a BSc, and you have a deep expertise & a proven experience in IIT study operations. You are a passionate Study Operations Expert with at least 7+ years in health compliance roles within the pharmaceutical industry.
You are a collaborative Manager with a high degree of partnership, with the ability to get along with cross-functional teams and work independently. Creative Problem-Solver, you are comfortable making decisions & designing creative solutions to support the development of strategies and implementing solutions swiftly. Proficiency in English is required, German is highly desirable, and any other European language is a plus.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way!
#J-18808-Ljbffr