WHO ARE WE?

ROPU MIDI is a Regional Operating Unit consisting of 8 mid-sized countries: Belgium, Denmark, Norway, Finland, Greece, Portugal, Sweden, and The Netherlands. MIDI is a multicultural and diverse work environment. More than 1.800 employees are striving to work together to improve lives for patients and animals in our region.

THE OPPORTUNITY

As the Real-World Evidence (RWE) Project Manager, you will support the Medical Affairs and Market Access teams across the MIDI region, by managing the operational aspects of RWE projects and processes (from planning to completion).

Furthermore, you will be responsible for overseeing and coordinating operational aspects of projects according to contract, ensuring quality, timeliness and adherence to budget and compliance.

You will have the opportunity to contribute to improved oversight and process adherence of RWE activities across the region and will support the process and system adoption as key user and in coordinative roles.

This role is based in our office in Amsterdam , in the new EDGE Amsterdam West (https://edge.tech/developments/edge-amsterdam-west) , a building with a modern and very sustainable architecture. You will report directly to the Team Lead Epidemiology & RWE MIDI .

YOUR KEY RESPONSIBILITIES

• Responsible for Project and Process management of RWE projects (e.g., Observation Non-Interventional Studies (ONIS), Investigator Initiated Studies (IIS), External Collaborative Research (ECR) etc.).

• Cooperate cross-functionally with the Epidemiologists, Project Owner in Medical Affairs, Market Access, TA teams, RWE teams, scientific publication manager across the MIDI region.

• Provide system, process, and project management support to the Project Owner during all phases of the activity (preparation, approval, conduct, closure – including reporting, publishing, archiving & disclosure/transparency).

• Accountable for all project deliverables – quality, timelines, and budget management.

• Prepares project management reports for multi-functional project team and management.

• Responsible for setting up and managing the project in systems used in the process in close collaboration with the actual Project Owner.

• Support learning activities, best practice sharing, and continuous improvement related to RWE processes and systems in the MIDI region.

• Support external stakeholders (HCPs) with their application and activity management on the Boehringer Ingelheim funding platform where applicable.

• Manage external vendors (communication, issue resolution, etc.).

• CRO selection and contracting in collaboration with the project owner and the interaction with purchasing and legal departments.

• Contribute to improvements of the RWE planning and oversight process across all local/regional RWE projects.

• Lead the CAPA process for RWE studies

• Ensure compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements and business practices.

WHAT YOU SHOULD BRING TO THE TEAM

• You have a Bachelor in Medicine, Pharmacology, Life Sciences, Epidemiology, Health Economics or similar.

• Minimum 3 years of experience managing RWE and/or clinical trial projects (from planning to completion) required in pharmaceutical industry.

• Knowledge of Real-World Evidence design, execution, and reporting is preferred.

• Experience in CAPA management is preferred.

• Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures.

• Scientific &/or technical understanding of the clinical development process and associated regulatory requirements.

• Operational expertise in RWE, IIS & ONIS.

• Ability to embrace new technologies.

• Experience working in cross-border teams, high matrix and / or in an international environment.

• Strong ability to manage time and work independently.

• Strong project management and presentation skills.

• Excellent command of the English language.

• Excellent interpersonal & communication skills – ability to distill issues, manage external stakeholders’ expectations and act in a timely manner to resolve issues.

WHAT WILL YOU GET IN RETURN?

Next to working in a Global Top Employer (https://www.top-employers.com/en/global-top-employers/) certified company that offers you the opportunity to develop and challenge yourself while learning from a fast-paced environment of our European MIDI region:

• Be part of a wellbeing-oriented organization (Premium access to Headspace , OpenUP and ongoing support and initiatives related to ways of working to help our employees to stay healthy and constantly improve the physical, emotional, mental, and spiritual well-being)

• Customized Development plan based on your role and aspirations, with several learning platforms such as LinkedIn Learning Premium (languages + training programs) and our Virtual Campus: Lifelong learning at our Virtual Campus | Boehringer Ingelheim (boehringer-ingelheim.com) (https://www.boehringer-ingelheim.com/about-us/corporate-profile/lifelong-learning-our-virtual-campus)

• A competitive salary range based on seniority and skills (plus annual bonus, 8% holiday pay and a company pension scheme)

• Green mobility package where you get compensated even for cycling to the office – which is an inspiring, sustainable (platinum-certified) building

• Hybrid workplace model – flexibility to work from home within the respective country and the office and 31 vacation days to re-energize

• A very diverse team (currently over 38 nationalities) that enjoys fun activities and celebrations (e.g., Team events, Christmas Party) and values a respectful working atmosphere!

What’s next?

We will have a look at your CV and cover letter. If we see a match, we will invite you for a video call interview to get to know each other. We will keep you posted during the process!

If you have any questions related to the recruitment process, please do not hesitate to contact Talent Acquisition MIDI: TalentAcquisitionMIDI.EU@boehringer-ingelheim.com

DIVERSITY & INCLUSION

At Boehringer Ingelheim we share the opinion that diversity and inclusion is essential for the growth of our business and that our strengths and competitive advantage are also the result of the diversity of our company – diversity across the three dimensions of inclusion: Gender, Geography and Generation. Our people are part of a deep-rooted, family company philosophy that welcomes everyone! We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Screening:

In order to comply with applicable export control laws, Boehringer Ingelheim periodically screens business relations (including job applicants) against sanctioned party lists (“SPL”). These checks may be performed by Boehringer Ingelheim or by any of its Affiliates. You acknowledge that Boehringer Ingelheim and/or its Affiliates will screen you against SPL and that for this purpose your personal data may be processed in relevant databases, including databases of third-party vendors that perform SPL screening for or on behalf of Boehringer Ingelheim or its Affiliates which may be located or accessible outside the EU. Boehringer Ingelheim is committed to ensuring an adequate level of protection of your personal data.

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.