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Operational Specialist in Medical Affairs
3 months ago
This position is integral to the Medical Affairs Excellence team, delivering essential operational support across various Medical Affairs (MA) therapeutic areas (TA) and facilitating cross-functional initiatives related to grant funding and collaborative market strategies.
The Medical Affairs Operations Specialist will oversee the Early Access Treatment Program, manage Investigator Initiated Studies (IIS), and coordinate External Collaborative Research (ECR). Additionally, this role will serve as the primary Medical Education Personnel (MEP in Lectrona) for all Human Pharmaceutical (HP) Grant funding requests, engaging with both internal and external stakeholders throughout these processes.
Key Responsibilities- Support for Medical Affairs & Market Initiatives:
- Assist all TAs in developing omnichannel strategies to deliver engaging digital and traditional medical content (e.g., e-Medical Affairs websites, medical education platforms, and email communications).
- Continuously enhance medical content and channel utilization based on customer feedback and evolving needs (i.e., maintain and update all MA content, including approved slide decks and other medically relevant materials).
- Coordinate the evaluation of innovative media and digital partnerships with the Customer Experience Operations Team to improve digital strategies and customer engagement within Medical Affairs.
- Compile operational and strategic data for Medical Affairs, capturing metrics for campaigns across digital and face-to-face activities for relevant stakeholders.
- Provide additional operational support for the Medical Affairs group as needed.
- Management of IIS Contracts:
- Oversee the development of IIS contracts in alignment with the assigned budget, ensuring the use of the most current approved contract templates.
- Facilitate the creation of legally sound external contracts by collaborating with the Medical Affairs Team and, if necessary, the legal department to ensure timely negotiations.
- Investigator Initiated Studies (IIS):
- Coordinate activities among Investigators, Local, and Global Medical Teams throughout the IIS lifecycle, including the receipt, review, approval, and documentation management.
- Monitor IIS project progress and deliverables, ensuring timely processing of payments and archiving of mandatory study-related documents.
- Facilitate collaboration between Investigators and Local/Global Pharmacovigilance teams, managing related safety data exchange activities.
- Local Lead for Lectrona Grant Funding:
- Manage the initial validation and triage of all HP grant funding requests submitted in Lectrona.
- Provide day-to-day support and troubleshooting for internal and external stakeholders during the funding request process.
- Lead the Grants review committee, collaborating with various business partners to ensure compliance with local instructions.
- Work with cross-functional partners to design and implement best practices for grant funding management.
- Collaborate with global Lectrona leads to integrate system and process updates.
- Conduct coordinated assessments of Lectrona funding activities aligned with MA and Quality Medicine objectives.
- Fair Market Value (FMV) Assessment:
- Conduct initial reviews and assessments of all Human Pharma HCP working levels, triaging to designated Medicine managers for final approval.
- Establish and maintain methodologies for determining FMV in compliance with local and global principles.
- Ensure timely communication of FMV assessments to local and global business partners.
- Support internal and external audits of local FMV processes.
- Facilitate training for FMV processing across HP functions.
- Early Access Treatment Program (EAT):
- Localize EAT documentation and processes, obtaining necessary regulatory approvals.
- Coordinate with various stakeholders in executing the EAT process.
- Manage documentation requirements for all EAT processes.
This role offers a flexible working arrangement, requiring employees to be present in the office a minimum of 50% of the time each month.
Qualifications- Bachelor's degree or equivalent post-secondary education.
- Bilingual proficiency in French and English, managing the Lectrona French mirror for all Medical processes.
- Proven experience in conducting clinical trials for investigational and marketed therapeutic agents.
- Familiarity with legal and contractual activities, as well as budgeting for clinical studies.
We provide a competitive salary along with a generous paid time off policy, comprehensive benefits, a Defined Contribution Pension Plan with company matching, and programs to support employee health and wellness.
Application ProcessWe appreciate the interest of all applicants; however, only those selected for an interview will be contacted.
Boehringer Ingelheim GmbH is committed to accommodating individuals with disabilities throughout the recruitment and selection process.
