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Medical Affairs Program Manager

3 months ago

Burlington, Ontario, Canada Boehringer Ingelheim GmbH Full time

This position is integral to the Medical Affairs Excellence team, providing essential operational support across various Medical Affairs (MA) functions, therapeutic areas (TA), and collaborative initiatives.

The Medical Affairs Operations Specialist will oversee the Early Access Treatment Program, manage Investigator Initiated Studies (IIS), and facilitate External Collaborative Research (ECR). This role will also serve as the primary Medical Education Personnel (MEP) for all Human Pharmaceutical (HP) Grant funding requests, engaging with both internal and external stakeholders throughout these processes.

Key Responsibilities
  • Support for Medical Affairs & Collaborative Initiatives:
    • Assist all therapeutic areas in developing omnichannel strategies to deliver engaging digital and traditional medical content.
    • Continuously enhance medical content and channel effectiveness based on customer feedback and evolving needs.
    • Coordinate the evaluation of innovative media and digital partnerships to improve customer engagement within Medical Affairs.
    • Compile operational and strategic data for Medical Affairs campaigns, providing insights on key performance indicators.
    • Provide additional operational support for the Medical Affairs team as needed.
  • Management of Investigator Initiated Studies (IIS):
    • Facilitate collaboration between Investigators and Medical Teams throughout the IIS lifecycle, ensuring timely review and approval of submissions.
    • Monitor IIS project milestones and manage documentation in compliance with established protocols.
    • Coordinate safety data exchange activities with local and global Pharmacovigilance teams.
  • Lead for Grant Funding Requests:
    • Oversee the initial validation of all HP grant funding requests.
    • Address day-to-day inquiries from stakeholders during the funding request process.
    • Lead the Grants review committee, collaborating with compliance and legal teams.
    • Work with cross-functional partners to establish best practices for grant funding management.
    • Engage with global leads to implement system updates.
  • Fair Market Value Assessment:
    • Conduct initial reviews of Human Pharma HCP engagements and triage for final approval.
    • Collaborate with local partners to maintain compliance with Fair Market Value principles.
    • Ensure effective communication of FMV assessments to support business planning.
    • Assist with internal and external audits of FMV processes.
  • Early Access Treatment Program Management:
    • Localize EAT documentation and processes, ensuring compliance with regulatory standards.
    • Collaborate with various stakeholders in executing the EAT process.
    • Manage documentation requirements for all EAT activities.

This role requires a Bachelor’s degree or equivalent post-secondary education, along with bilingual proficiency in French and English. Candidates should have demonstrated experience in clinical trials and knowledge of legal and contractual processes related to clinical studies.

Compensation and Benefits

We offer a competitive salary, a generous paid time off policy, a comprehensive benefits package, and a Defined Contribution Pension Plan with company matching.

Application Process

We appreciate the interest of all applicants. Only those selected for an interview will be contacted. We are committed to providing accommodations for individuals with disabilities throughout the recruitment process.