Job Description
THE POSITION Reporting to the Medical Affairs Excellence Manager, the Medical Affairs Operations Specialist (MAOS) provides operational support across Medical Affairs (MA), Therapeutic Areas (TA), and cross-functional teams. Key responsibilities include managing Grants, Early Access Treatment (EAT) Special Access Programs (SAP/OOS), Fair Market Value (FMV) processes, Investigator-Initiated Studies (IIS/ECR), support and KPI tracking.
The MAOS acts as the lead for these functions and serves as the department champion for platforms such as BOOST, LECTRONA, and the One Medicine Platform (OMP). The role supports all Human Pharmaceutical (HP) interface activities with internal and external stakeholders.
The key accountabilities and performance indicators form the foundation of this role. Additional responsibilities may be assigned as needed to support evolving business priorities.
Responsibilities Key Performance Indicators (KPI) & Strategic Data Management - Assemble strategic and operational Medical Affairs data and metrics, including campaign metrics for digital and in-person activities
- Serve as the liaison between local operations, Cardio Renal Metabolic (CRM), Global Medical Affairs, Therapeutic Area Directors, and the Medical Excellence Manager
- Lead analytics and support for field-based MA KPIs, portals, dashboards, and communications to ensure local and global alignment
- Identify and resolve challenges in KPI monitoring across local and global dashboards
Fair Market Value (FMV)- Lead the FMV process and monitor the FMV mailbox to execute requests via automation
- Collaborate with the Compliance Lead on governance and administrative updates
- Act as the primary resource for FMV-related Standard Operating Procedures (SOPs), legislation, and compliance queries
- Conduct first-pass FMV assessments under delegated authority and triage to Medicine Managers for final approval
- Maintain and update the FMV methodology (Master BI file) in alignment with BI global principles
- Communicate FMV decisions to cross-functional stakeholders to support planning and execution
- Support internal/external audits and FMV training across HP functions
Investigator-Initiated Studies (IIS)- Coordinate IIS lifecycle activities between Investigators and Medical Teams
- Administer contract development and execution within budget using approved templates
- Track project progress and deliverables in LECTRONA and related systems
- Ensure timely payments and documentation archiving per SOP
- Coordinate safety data exchange with Pharmacovigilance teams
- Provide operational support for compliance (e.g., CASL, PIPEDA)
Lectrona Grant Funding - Manage triage and validation of HP grant requests in Lectrona
- Troubleshoot submission and review processes with stakeholders
- Support the Lead for the Grants Review Committee and coordinate with cross-functional partners
- Collaborate on best practices, guidelines, and training for grant management
- Liaise with global Lectrona leads for system/process updates
- Analyze local compliance requirements and reporting needs
- Track and report grant spend and execution outcomes
- Serve as a governance resource for Grants SOPs
Fair Market Value (all HP)- With delegated authority from Ethics and Compliance / Legal / Medicine, performs first-pass review and assessment of all Human Pharma Health Care Provider (HCP) working level (tier). The MAOS then triages to a designated Medicine manager for final approval
- In collaboration with local business partners, establishes and maintains the methodology (Master Boehringer Ingelheim file) for determining and complying with FMV in Canada/Boehringer Ingelheim global principles for the engagement of external stakeholders
- Ensure timely communication of assessment and FMV decisions to cross-functional business (local and global) partners to enable business planning and execution
- Supports internal and external auditing of local FMV assessments and processes
- Supports local training for FMV processing across HP functions
Early Access Treatment Program (EAT)- Localize EAT documentation and obtain regulatory approval
- Liaise with internal, external and global stakeholders for EAT execution
- Monitor BOOST mailbox for requests and communication from external stakeholders
- Coordinate drug supply with Clinical Trial Supplies Unit (CTSU) and relevant partners
- Manage documentation requirements in BOOST
- Act as BOOST platform champion and liaison
- Serve as key contact for Health Canada and external HCPs
- Provide monthly and ad hoc reports to the Medical Excellence Manager
This position is based in the Burlington, Ontario office located at 5180 South Service Road and is
flexible. Employees in flexible roles are required to be at the office a minimum of 50% of the time each month and must report to the office when requested and required by their Manager/Department.
Requirements - Bachelor's degree (Business or Science is preferred)
- Minimum 2 years of operations experience supporting or leading operational processes; preference for medical operations
- Cross-functional Collaboration: Proven ability to work with Legal, Compliance, Pharmacovigilance, Regulatory, and external stakeholders
- Governance & Compliance: Experience with SOPs, audits, and compliance frameworks
- Clinical Research Support: Familiarity with IIS lifecycle management and documentation is an asset
- Project & Time Management: Manage multiple complex processes and timelines
- Communication: Strong written and verbal communication skills
- Analytical & Reporting expertise
- Technical Proficiency: Advanced knowledge of MS Office
- Negotiation & Contracting: Experience in contract development and negotiation
- Regulatory Knowledge: Understanding of ICH/GCP, Health Canada regulations, IMC Code, and SOPs
- Initiative & Independence: Work autonomously and solve problems proactively
- Attention to Detail: Ensure accuracy in documentation and reporting
- Confidentiality: Handle sensitive data with discretion
- Customer-Centric Mindset: Focus on stakeholder satisfaction
- Adaptability: Navigate evolving systems and regulatory landscapes
- Bilingualism (French and English) is preferred
Total Rewards We offer a competitive salary, generous amount of paid time off (vacation, personal days, contingency paid time off days for Long Term Contract Employees), comprehensive and flexible benefits plan, Defined Contribution Pension Plan with company matching of RRSPs, Employee and Family Assistance Plan, employee and leadership development programs, and programs to support overall health and wellness for employees.
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READY TO APPLY? Click the "Apply Now" button below to submit your application. We thank all applicants for their interest in our company. Please note that only candidates selected for an interview will be contacted. Boehringer Ingelheim Canada is committed to providing accommodations for people with disabilities to support their participation in all aspects of the recruitment and selection process. If you require accommodation, we will work with you to meet your needs.
DEADLINE FOR APPLICATIONS Applications for this position will be accepted until December 1, 2025.
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Our Company
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Job Tags
Long term contract, Contract work, Work at office, Local area, Flexible hours,