Local Medical Safety Process Head
il y a 2 semaines
Remote work options may be considered on a case-by-case basis and if approved by the Company._
In this position, you will:
- Oversee and drive the LMS (Local Medical Safety) process strategy including Business owner and approval structure in Local Medical Safety and the creation and sunsetting of processes.
- Serves as a member of the LMS Operations Leadership Team.
- Be responsible for management, leadership, and delivery of process-related components of the Local Medical Safety strategic plan. You will ensure processes developed or modified continue to enable compliance with local and regional regulations for Local Safety Units.
- Be the lead to evaluate opportunities, gain alignment among Local Medical Safety Leadership teams, as well as GMS (Global Medical Safety Operations (GMSO)), R&DQA (Research & Development Quality Assurance) (Research & Development Quality Assurance) (Research & Development Quality Assurance) and MSQ (Medical Safety Quality) colleagues (where applicable).
- In collaboration with Director Local Medical Safety Systems, ensure impact assessment is performed on existing processes/procedures following systems updates and applicable training is delivered.
- Develop strategy and infrastructure to ensure seamless review and approval of data generation programs with stakeholders.
- Oversee for equitable opportunity and appropriate allocation of assignments to team members, especially prioritization and resource allocation. Provides coaching, support, and guidance. Manages budget for function.
- Directs Managers and/or senior individual contributors in a matrix environment and is accountable for meaningful career development conversations and regular coaching and feedback.
- Provides vision and direction in the development of processes and risk-based assessments for the organization's pharmacovigilance activities.
**Key responsibilities**:
5%
- Be an ambassador of the LMS culture, vision, and mission.
- Advocate priorities and concerns of all LMS regions and functions to the LMS Leadership team, to the broader GMS organization and other governance bodies within J&J.
- Lead or participate in global multi-disciplinary projects and shape strategies for the projects assigned.
40%
- Lead the execution of strategies for the Local Medical Safety Process team.
- Drive continuous improvement of Local Medical Safety owned processes.
- Influence processes owned outside of Local Medical Safety to increase efficiency and compliance in cooperation with stakeholders.
- Provide oversight and strategic guidance for management of procedural documents, shaping the development, maintenance, and retirement including training within Local Medical Safety in line with evolving regulatory landscape demands.
- Sponsor, lead, or oversee Local Medical Safety Projects and ensure transparency to progress for the appropriate Local Medical Safety Organization and Global Medical Safety Operations audiences.
- Understands the process differences across all J&JIM (Johnson & Johnson Innovative Medicine) local operating companies including why those differences exist. Works to drive consistency and minimize exceptions to the processes.
- Is Subject Matter Expert (SME) on controlled procedure development and implementation including document writing, alignment with other functional areas, document review, and approval process and systems (e.g., TruVault).
- Ensures all Corrective Action Preventive Actions, Effectiveness Checks, Commitment Records documentation related to any new or existing Local Medical Safety controlled procedure, or Local Medical Safety responsibility in other-owned procedure is aligned with Local Medical Safety Strategy.
- Ensures establishment of process Subject Matter Experts in new areas of pharmacovigilance and liaises with internal business partners as needed. Is primary escalation point to solve inter-departmental impasses in the development/revision of processes. Escalates appropriately to appropriate stakeholders.
- Partner with Local Medical Safety teams to improve overall compliance and efficiency in data generation programs.
20%
- Develop strategy for composition and maintenance of Local Medical Safety Curricula in close cooperation with Medical Safety Quality (MSQ).
- Develop strategy and oversee Procedural document framework in cooperation with MSQ, including a consistent approach for impact assessments within Local Medical Safety.
- Coordinate roll-out of new/revised training role profiles and competency model - in cooperation with Local Medical Safety Talent Development.
- Oversee global strategy for onboarding programs and support regions to develop strategy for Local Safety Officer (LSO) onboarding programs - in cooperation with Local Medical Safety Talent Development.
10%
- Provide strategic direction to Local Medical Safety Process Team.
- Directs Managers and/or senior individual contributors in a matrix environment and is accountable for meaningful career development conversations
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