Local Medical Safety Process Head
il y a 1 semaine
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 processrelated 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 riskbased 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 multidisciplinary projects and shape strategies for the projects assigned.
- 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 otherowned 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 interdepartmental 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.
- 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 rollout 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.
- 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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