Mgr Medical Study Operations

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 out 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 decision & design creative solution design skills 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.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.