Medical Affairs Operations Manager

Janssen Pharmaceutical, Companies of Johnson & Johnson is currently hiring a Medical Affairs Operations Manager, located in Toronto, ON.

About Janssen Inc.

**Position Overview**:
The Medical Affairs Operations Manager, provides leadership to the team of Operations Leaders and is responsible for supervising the set up and operational ownership of asset content process, approvals, vendor management, contract management, events management system and contract approvals and budgeting. The Manager supervises the operational execution of compliance documentation and approvals as well as vendor relationships. The Manager will supervise that all events are operationalized in alignment with laws, regulations, policy, and Corporate Compliance and identify operational efficiency gains across medical affairs, working closely with the Healthcare Engagement team.

The Manager of Medical Affairs Operations will support leaders on tactical processes and will work closely with event owners of med events and advisory boards. They are responsible for a team that owns the preparation, conduction, closure and reconciliation of events. The team will be responsible for overseeing content review and provide operational and impact metrics to the national education leaders as well as the Director of Medical Education, always ensuring audit-readiness.

**Business and People Leadership**:

- Lead all aspects of the Operations team on Medical Event preparation and Project Management
- Leads the Operational Med Ed team to work with event owners on yearly plans
- Management of contractual arrangement with external providers including vendors and 3rd party developers
- Responsible for preparation, conduction and closure and reconciliation of congress symposia operations
- Together with event owner, lead the medical communication, production (including digital production via Digital team) and logistics agencies for these events
- Lead medical review content review process between agency and internal IMR portal
- Follow-up with involved agencies on budget estimates, work orders/contract, invoices, payment processes, PO process/closure, budget reconciliation
- Coordinate event wrap-up and evaluation including feedback for business partners
- Coordinate monthly department-wide operational and impact metrics for Director of Med Education
- Liaise with Associate Directors, Medical Education to ensure operational excellence of medical events

**Operational Leadership**:

- Provides direction to a team of medical affairs operations leaders
- Responsible for identifying efficiencies and commonalities across medical affairs operational process activities
- Responsible for supervising the operations portion of the departmental budget and asset-specific budgets and support budget owner with reconciliation
- Management of all aspects related to event project management: POA development, iCONNECT submission, post event filing and archiving
- Review agency budget proposals
- Request and lead departmental POs and Vendor SOWs
- Manage preferred vendors, contracts and operations
- Integrate any industry or regulatory policy changes into current processes
- Ensures the tracking and reporting on status of several projects and confirms ongoing evaluations of programs

**Compliance Subject Matter Authority**:

- Understands the needs of the medical education functional area and underlying business processes and opportunities
- Keep up to date with trends in content, compliance and industry benchmarking
- Supervises operational KPIs to drive continuous process improvement

**Business Readiness**:

- Supports the therapy areas med ed strategies and workflow for educational assets
- Support the Med Ed team by providing mentorship on operational efficiencies

**Qualifications**

**Qualifications**:

- A minimum of 5 years of experience in the pharmaceutical industry, or medical education field or professional business experience is required
- Exhibited strong people and project management skills
- Strong communication and collaboration skills with ability to showcase leadership of cross-functional project (matrix) team members
- Understanding of agile ways of working
- Results driven, innovative, assertive, strategic problem solver, strong project and account leadership skills are preferred
- Demonstrated experience of change management and adoption
- Knowledge of pharmaceutical regulated standards (IMC Code of Ethical Practices, ICH GCP, cGMPs, or Pharmacovigiliance standards) and experience working with Health Care Compliance functions.
- Strong written, verbal and presentation skills
- Proficiency in metrics and reporting, creating dashboards and scorecards, and presenting complex information at the right tone and breadth
- Experience in continuous improvement and or quality improvement processes
- Strong analytical, time leadership, organization and prioritization skills
- Proficiency in Microsoft Excel, Project, Visio, PowerPoint, Adobe Acrobat, Google Analy