Medical Affairs Operations Lead

Janssen Pharmaceuticals, LLC, a member of Johnson & Johnson's Family of Companies, is currently hiring a Medical Affairs Operations Lead, to be located remotely in Canada.

Position Overview

The Medical Affairs Operations Lead will partner with the National and Regional Medical Education Managers (NMEM/RMEMs) and focus on program process strategy and the development and coordination of key multi-channel tactical solutions to ensure the achievement of the Therapeutic Area’s strategical educational vision, in alignment with the Medical Affairs leaders.

They build and sustain organizational education capabilities to ensure activities are aligned with laws, regulations, policy, and Corporate Compliance objectives. Will follow project management principles to maintain key milestones on achievement of operational excellence of medical education goals and objectives (Key Performance Indicators). They will collaborate with internal and external partners, manage the contractional arrangements, compliance approvals and budget reviews for medical events as well as prepare budget recommendations in connection with vendors. They will also compile and distribute metrics and feedback to the event owner (NMEM, RMEM or Med Dir). This position is designed to create greater project management oversight for each medical education event and identify commonalities to capitalize on process efficiencies.

Core Responsibilities:
Project Leadership
- Lead the developmental process of the national and regional Medical Education plan, ongoing execution, and budgeting of initiatives including regional and national speaker tours, advisory boards, symposia, conferences, and other tactics as required by the Medical Integration Team (MITs)
- Align with the NMEM and/or RMEM on the objectives and resources required to develop and implement the national and regional medical education plans
- Analyze industry trends, competitive programs, and proprietary data for practical insights to incorporate into educational solutions
- Development of relationships with key regional, national, and/or international KOLs to support the development of educational assets or activities (as required, in collaboration with RMEM)
- Other Learning Activity (OLA) Process oversight
- Faculty, and steering committee management
- Vendor Management: selection, briefing, and oversight
- Submission and management of all related OLA documents into the internal approval processes (iMR)
- Completion and submission of compliance review forms, adhering to both national & international guidelines.
- When applicable, organize and lead Train the Trainer events
- Partner closely with the Health Care Engagement team
- Develop and implement Field Communication plans (Pre event plan, Event registration updates and Post event summaries)
- Management of Accredited programs that are submitted via Educational Grant portal
- CPD liaison
- Liaise with Grants Coordinator

Operational Leadership
- Establish and present Project Briefs to agencies
- Review agency project and budget proposals
- Administration of POA process-updates to event lead (NMEM, RMEM or Med Dir)
- Request and lead departmental POs and Vendor SOWs
- Follow up on and reconciliations, support budget owner with reconciliation review of events
- Lead preferred vendors (new/renewal), approval, MSA/HCC process and oversight
- Lead steering committee and speaker contracts

Customer Advocate
- Understands the needs of the medical education functional area and underlying business processes, needs, and opportunities via collaboration with NMEM/RMEM
- Able to enlist other SMEs from the organization as needed (from other related programs)
- Enlist SMEs from the Therapy Areas as necessary
- Communicator and trend identification
- Able to clearly articulate priorities to internal Med Ed partners
- Able to analyze trends/findings related to the development of medical educational channels

**Qualifications**
Education

Required
- A minimum of 5 years of experience in the pharmaceutical industry, medical education field or educational field
- Knowledge of pharmaceutical regulated standards (IMC Code of Ethical Practices, ICH GCP, cGMPs, or Pharmacovigilance standards)
- Demonstrated proficiency and experience in project management and continuous process/quality improvement
- Strong communication and collaboration skills with ability to showcase leadership of cross-functional project team members
- Proficiency with Microsoft products, Adobe products, and strong ability to learn other technology quickly
- Understanding of agile ways of working
- Demonstrated experience on organizational change and adoption
- Strong written, verbal and presentation skills
- Proficiency in metrics and reporting, creating dashboards and scorecards, and communicating complex information at the right tone and breadth
- Strong analytical and time management skills
- Prioritization and organization of workflow activities to meet tight deadlines
- Superior lev