Medical Affairs Operation Specialist

Job Responsibility:

THE POSITION

This role reports into the Medical Affairs Excellence; providing operational support across Medical Affairs (MA), the MA therapeutic areas (TA) and cross-functionally in the management of grant funding and One Team (go-to-market) initiatives. The MA Operations Specialist will lead the Early Access Treatment Program, the project management of Investigator Initiated Studies (IIS) and External Collaborative Research (ECR). In addition, this role will function as the lead Medical Education Personnel (MEP in Lectrona) for all Human Pharmaceutical (HP) Grant funding requests and interface with both internal and external stakeholders for these activities.

Responsibilities

Integration and Support for Medical Affairs & Go-to-market (One Team) Activities

• Support all TAs with omnichannel development to deliver dynamic digital and traditional channel medical content (i.e., e-Medical Affairs websites, medical education platforms, follow-up and head office email etc.
• Iterate and improve medical content and channel usage based upon understanding of customer utility, evolving needs and tools (i.e., maintain and update in-system all MA content including approved slides decks as well as other medically relevant material approved for external use)
• Coordinate the assessment of novel media and digital partnerships, with the Customer Experience Operations Team, to enhance digital strategies and customer engagement within Medical Affairs. Assist agency/partner alignment and coordination to support design of the digital content and, ultimately, better customer experience.
• Assemble Medical Affairs operational, strategic data and metrics (i.e. MA campaign metrics capture for digital and face-to-face activities for Therapeutic Area Directors, Field Based Medicine Managers, MA Education & Operations Manager and Vice President of MA on relevant KPIs.
• Other operational support for the Medical Affairs group as required (i.e. CASL, PIPEDA etc.).
• Administers the development of the IIS contract in accordance with assigned budget execute and implement this process using the most up to date approved contract template. Develops legally sound external contracts though coordination with Medical Affairs Team and if necessary with legal group to ensure timely and cost-effective negotiation outcomes.

Investigator Initiated Studies (IIS)

• Coordination of activities between Investigator, Local and Global Medical Teams through the lifecycle of the IIS including receipt, review, approval and release of IIS submissions to the end of the study lifecycle and the management of all related documentation within Lectrona.
• Administers the development of the IIS contract in accordance with assigned budget. Execute and implement this process using the currently approved contract template. Develops legally sound external contracts though coordination with Medical Affairs Team and if necessary with legal group to ensure timely and cost-effective negotiation outcomes.
• Tracks IIS project progress and receipt of deliverables through documentation in all required IIS management systems and documents repository platforms as per the IIS SOP, with timely and accurate processing of payments and archiving of mandatory study-related documentation.
• Coordination of activities between Investigator, Local and Global Pharmacovigilance and management of related safety data exchange activities and associated records.

Local Lead for Lectrona Grant Funding (all HP)

• Manages triage and first-pass validation for all HP grant funding requests received in Lectrona.
• Perform day to day troubleshooting with internal and external stakeholders throughout the submission / review / execution process of a funding request.
• Coordinates and leads the Grants review committee including the Chief Compliance Officer, Legal, MA Education and Operations, and other business partners as per local working instructions.
• Under the direction of leadership, works in collaboration with cross-functional partners such as: Ethics and Compliance, Legal, Quality Medicine and other business partners to design and implement grant funding management best practices, guidelines, processes and training.
• Liaise with global Lectrona leads to identify and incorporate system and process updates
• Performs analysis to gather local compliance / business requirements for the management of third party funding requests; i.e. reporting
• Develop and maintain a coordinated assessment/review of Lectrona funding activities based on MA / Quality Medicine goals and objectives.

Fair Market Value (all HP)

• With delegated authority from E&C / Legal / Medicine, performs first-pass review and assessment of all Human Pharma 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 BI file) for determining and complying with FMV in Canada/BI 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 (OOS/SAP)

• Localize EAT documentation/processes and gain regulatory approval; as applicable in Canada
• Liaise (as required for each process) with the Vice President Medicine and Regulatory Affairs, the Therapeutic Area Directors,(Global/Local)Medical Advisors, Medical Affairs Healthcare Compliance, Legal and global team members in the execution of the EAT process
• Case-dependent, coodinate EAT drug supply with Clinical trial supply Unit (CTSU) and relevant business partners.
Manage the documentation requirements for all EAT processes (CTMS,BIRDS)

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
• Bilingualism in English and French is an asset (will manage Lectrona French mirror for all Medical processes; IIS / ECR / Grants).
• Demonstrated experience in conducting clinical trials of investigational and marketed therapeutic agents or equivalent.
Knowledge and experience in legal/contractual activities and budgeting for clinical studies.

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 June 11, 2025.

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