Manager 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 lifetransforming medicines for people with serious diseases were establishing new ways to approach science manufacturing and commercialization. And new ways to think about health!

Manager Medical Study Operations OncoHematology 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 startup activities timelines budgets and reports in support of Externally Sponsored Research (ESR) including InvestigatorInitiated 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 startup 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 companys 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 OncoHematology
• 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 crossfunctional teams and work independently. Creative ProblemSolver 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.

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits which often include (depending on location) health and wellness programs fitness centers equity awards annual bonuses and paid time off for eligible employees at all levels!

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 Companys business.

For roles in which the hired candidate will be working in the U.S. the salary ranges provided are shown in accordance with U.S. law and apply to U.S.based positions. For roles which will be based in Japan and/or Canada the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S Japan or Canada please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity right to work educational qualifications etc.