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Local Medical Safety Process Head - 2406179137WDescriptionJohnson and Johnson Innovative Medicine is recruiting for a Local Medical Safety Process Head, for candidates near a Johnson & Johnson Innovative Medicine location in ASPAC, LATAM, EMEA or North America.Remote work options may be considered on a case-by-case basis and if approved by the Company.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.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.
Apply risk-based decision making in the development or revision of procedures and lead team members in the same skill set development.
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.
Ensure Local Medical Safety sustains subject matter expertise on the procedures owned by Local Medical Safety and for which Local Medical Safety has an oversight responsibility.
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, regular coaching, and feedback.
Evaluates the performance of the organization's practices, policies, and procedures, ensuring adherence to organization standards and quality.
Contributes to business objectives through streamlining departmental activities and administering changes based on PV landscape trends and external party feedback.
Responsible for managing operational aspects of their teams (e.g., budget, performance, and compliance), as well as implementing workforce and succession plans to meet business needs.
Proactively creates a purpose driven environment by aligning Johnson & Johnson’s Credo and Leadership Imperatives with the strategies and goals of the team and enterprise
15%
Ensure all process changes include assessment of resource implications to evaluate success of implementation/unexpected effects to resources.
Working with Local Medical Safety Strategy Realization, ensure the Local Medical Safety resource model remains current with changing regulatory requirements and associated procedures.
Liaising with the Local Medical Safety Vendor Lead, share when a revised process can be outsourced or when vendor training or source materials must be amended due to modified/harmonized procedures.
Receive and evaluate feasibility of requests from Local Medical Safety Leadership Teams for outsourcing. If appropriate, assign or initiate project plan to explore feasibility. Partner with Local Medical Safety Vendor Lead and Vendor Capacity Management for RFP (Request for Proposal) process.
10%
Oversee day-to-day all process-related projects with current knowledge of implementation status, reasons for status, results, success. Responsible for oversight and reporting out on implementation status to Local Medical Safety and other stakeholders.
Contribute to/produce materials quarterly summarizing accomplishments/progress in the various projects under responsibility of this role. Develop quantification measures to provide quarterly/year end picture of accomplishments in all projects. Present materials to Local Medical Safety/GMS and OCMS (Office of the Chief Medical Officer) audiences, as requested.
QualificationsRequired:
Bachelor's or similar degree required.
A minimum of 10 years of relevant experience
A minimum of 5 years of people management experience
Proven ability to present complex topics appropriate for audiences of all levels.
Proven ability to organize workflow activities and manage multiple critical issues.
Awareness of, and familiarity with, J&JIM/MedTech systems, procedures, and pharmacovigilance requirements.
Knowledge of Global, Regional, and Local Procedures related to Local Medical Safety accountabilities and vendor services.
Computer literate with knowledge of relevant Information Technology safety systems.
Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers.
Ability to establish and maintain open relationships within the organization.
Fluency in English language is required.
Project management or leadership experience is required.
Microsoft Office Suite literacy.
This position requires up to 25% travel.
Preferred:
Graduate degree (e.g., Master's Degree, PhD, PharmD) preferred.
Operational Excellence or FPX (Flawless Project Execution) program completion
Process Excellence certification is a plus.
Experience within an International Pharmacovigilance environment is preferred
For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $157,000 to $271,400.This job posting is anticipated to close on 4/11/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).This position is eligible to participate in the Company’s long-term incentive program.Employees are eligible for the following time off benefits:
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below.For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefitsJohnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .Primary Location Europe/Middle East/Africa-Belgium-Antwerp-BeerseOther Locations Asia Pacific, Latin America, North America, Europe/Middle East/AfricaOrganization Janssen Cilag N.V./S.A. (7025)Job Function PharmacovigilanceReq ID: 2406179137W
