Early Access Treatment Coordinator MIDI

Boehringer Ingelheim Pharmaceuticals, Inc.; Amsterdam; Hybrid; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Headspace access

Hybrid work model

31 vacation days

Company pension

Wellbeing initiatives

Performance bonus

Job summary

Boehringer Ingelheim Pharmaceuticals, Inc. in Amsterdam is seeking an Early Access Treatment Coordinator (EATC) MIDI to coordinate and execute day-to-day Early Access Treatments across the MIDI region.

You will collaborate with operating units, local regulators, and clinical teams to ensure compliant, timely delivery and documentation of programs. The role emphasizes cross-functional work, local documentation localization, and safety reporting setup in collaboration with MIDI stakeholders.

Qualifications

• Bachelor or higher in Life Sciences or related field.
• Experience in Medical/Scientific operations and regulatory work.
• Knowledge of GxP and regulatory requirements.

Responsibilities

• Coordinate cross-functional activities for local EAT processes.
• Adapt global core documents to local regulations.
• Set up safety reporting with pharmacovigilance where applicable.
• Manage contract review and signature processes with centers/physicians.
• Ensure timely, compliant program execution and documentation.

Skills

Communication skills

Cross-functional collaboration

Time management

Regulatory knowledge

GxP knowledge

Stakeholder management

Self-motivated

Education

Bachelor degree in Life Sciences

Tools

Microsoft Office

Job description

ROPU MIDI is a Regional Operating Unit that covers all local Human Pharma and Animal Health Operating Units across Belgium, Denmark, Norway, Finland, Greece, Portugal, Sweden, and The Netherlands. MIDI has 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

Are you energized by working across countries, functions, and stakeholders to bring innovative treatment options to patients? Join our team and play a key role in coordinating Early Access Treatment programs across the region, ensuring seamless execution, compliance, and patient-focused outcomes.

The Early Access Treatment Coordinator (EATC) MIDI is responsible for coordinating and executing the day-to-day activities related to Early Access Treatments (EAT) across the MIDI ROPU (Regional Operating Unit). This includes creation and filing of relevant documents in collaboration with the OPUs (Operating Units) and tracking all required parameters in the relevant systems.

The EATC MIDI is responsible for setting up effective and efficient collaboration, for internal and external program communication, and for program execution and for documentation and tracking thereof at MIDI level for individual EAT programs

Furthermore, the role supports localization of the relevant core documents and creation of required local documents for regulatory submission (if needed) in collaboration with MIDI stakeholders.

This position is based in Amsterdam and reports directly to the Medicine Operations Manager MIDI.

Please note that a 1-year fixed term contract initially will be offered.

HOW YOU’LL FIT IN:

• Ensure on-time and high-quality execution and management of programs for early access to new treatments (considering Global SOPs and regional and local regulations and processes) across the MIDI region in collaboration with OPU (operating unit) stakeholders.
• Coordination of the cross-functional activities associated with the conduct and management of local EAT processes.
• For applicable programs, adapt Global core documents to Local core documents according to local regulation / legislation and oversee local regulatory submissions.
• In collaboration with local pharmacovigilance, set up safety reporting for participating OPUs, if applicable.
• Coordination and follow-up of contract review and signature process with participating centres / physicians.
• Adherence to processes and timelines.
• Tracking of Boehringer and site personnel, project status, dates and documents in the applicable system/s.
• Monitor program status and work with OPU Medical Director and MIDI Medical Operations Manager to make sure any risks, dependencies and roadblocks are raised and addressed.

YOU BRING:

• Bachelor degree in the Scientific Field/ Life Sciences.
• Several years of relevant experience in the medical area (ideally in Clinical Trials and/or Early Access Treatments such as compassionate use).
• Experience across various operational activities in the Medical/Scientific area, preferably in Medical Affairs Operations.
• Familiar with GxP and regulatory requirements.
• Knowledge about the concept of Early Access Treatment is a plus.
• Project coordination and time management skills and experience, with the ability to manage multiple projects simultaneously.
• Ability to build and maintain meaningful & trusted relationships with others, in order to balance acting as a solutions-oriented escalation point of contact for internal customers and getting things done.
• Highly skilled in Microsoft Office Suite.
• Excellent communication skills in English - in a non-arrogant, customer-oriented, but impactful and trustworthy way.
• Ability to work cross-functionally and at regional scale with excellent technical skills.
• Self-motivated, self-starter, and quick learner.

WHAT WILL YOU GET IN RETURN?

Next to working in a Global Top Employer 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)
• A competitive salary range based on seniority and skills (plus annual bonus, 8% holiday pay and a company pension scheme)
• Hybrid workplace model – flexibility to work from home within the respective country and the office and 31 vacation days to re-energize
• Option to temporarily work from abroad for a limited period (up to 30 working days) - if applicable.
• A very international team that enjoys fun activities and celebrations (e.g., Team events, Christmas Party) and values a respectful working atmosphere!

Please note that pay information will be shared during the recruitment process.

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.