Senior Manager Clinical Trial Office (m/f/x) - 20h per week

For our EU regional headquarters (position can also be based in an EU affiliate) we are seeking highly qualified candidates to fill the position:

Senior Manager Clinical Trial Office (m/f/x) - 20h per week

The Position

• Position could be filled Europewide, Munich preferred

• Position is a part time role, 20h/week, preferred whole days or afternoon

• Unlimited position 

Purpose of the function

To serve as a Regulatory Manager for assigned projects and products in the area of Clinical Trials. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally. Supporting the clinical study teams and other relevant stakeholders, providing EU regulatory strategic project management to the Global Clinical Study Teams. Represent Regulatory Affairs on clinical trial related matters working with authorities, affiliates, partners and CROs.

Roles and Responsibilities

• Act as a regulatory contact person for European clinical trial matters within Daiichi Sankyo RA

• Support with advice and provide clear information to clinical study teams on administrative and process related aspects of clinical trial submissions in Europe (EU, UK, CH)

• Act as a coordinator of responses to agency questions (RFI) within the study team for studies in Europe (EU, UK, CH)

• Review and interpret regulatory guidelines on a regular basis, especially the Clinical Trial Regulation and provide advice and guidance to peers and EU RA study representatives

• Advise the regulatory strategists and EU product leads on response to RFIs processes

• Participate or lead assigned non-project tasks and process improvements such as eTMF, SOPs, and anything related to the CTR

• Become an expert in Clinical Trial Information System (CTIS) and support and guide study teams and other users

• Keep current with review and interpret Daiichi Sankyo procedures, Daiichi Sankyo internal and external tools and systems and key regulatory regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders

Education & Experience

Education

• University Degree (Bachelor, Master, State Examination, Diploma) in Pharmacy, Medicine, or Life or Natural Sciences or University Degree in Medical Science PhD  

Work Experience

• 2 to 5 years: Working experience in Pharmaceutical Industry, at Clinical Research Organizations or at an EU Regulatory Authority with 2- 5 years of experience in Regulatory Affairs with an emphasis on clinical trials

• Project Management skills would be a plus

• Experience in managing clinical trials in other regions is a plus

• Experience of working in global environment

• Proven ability to plan, coordinate and lead activities simultaneously on multiple project

Skills and additional Requirements

• Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization

• Ability to develop and maintain good relationships, gain the trust of others, challenge views and present and argue cases in a professional and respectful manner

• Solution and detail-oriented

• well organized and self-motivated

• Excellent written and oral communication skills in English, second EU language preferred