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The Associate Director, Vendor Oversight Lead within the Global Medical Organization (GMO) manages the relationship with safety vendors and provides contractual strategies to drive sustainable on-time reporting compliance. Manages global vendor relationship to ensure vendors meet defined performance indicators including quality, performance, and timelines. Responsible for contributing to development of Service Level Agreements, collaborating with global business partners to achieve global alignment, corporate standards including on time compliance and reporting as well as with compliance with the requirements set out in the Master Services Agreement(s), aiming to ensure third-parties meet J&J expectations across the Enterprise.

Primary responsibilities:

Serve as a liaison with regional and cross-sector business partners to ensure compliance with agreements and J&J Policy:

• Set strategic vendor direction, define and maintain an optimum vendor operating model associated with delivery and maintenance of submissions and full product license lifecycle management to multiple regulatory authorities.

• Contribute to the development and evolution of the Enterprise-wide Pharmacovigilance outsourcing strategy.

• Participates in investigations relating to significant process deviations by the Vendor, oversee Corrective and Preventive Actions (CAPAs) resulting from the investigations, and notify management of key issues affecting the quality of the pharmacovigilance system.

• Lead cross-functional governance teams to ensure strategic alignment of priorities among key business stakeholders relating to vendor management.

Provide Inspection and Audit Leadership Support:

• Provide the required support and J&J representation as appropriate to the third parties during FDA, MHRA, EMA regulatory inspections and internal audits in collaboration with Compliance Strategy and Analytics, Quality Assurance and internal Vendor Management functions.

• Participate in investigations relating to vendor significant deviations and support development and tracking of any subsequent CAPAs resulting from the investigations.

Provide Contracting and Program/Project Management Support:

• Program and project management of strategic projects

• Oversee operational aspects of projects including planning, communication, tracking timelines, training, implementation, budgets and resources. Continually communicate status and concerns to GMO management.

• Serve as a liaison with internal business partners including GMO, Finance, IT, Procurement, Legal, and external business partners / suppliers to facilitate the processing of contracts.

The Position:

• Manages vendor relationship and training and resolves potential issues

• Manages functional contracting discussions in partnership with procurement

• Participates in cross-functional governance teams to ensure alignment of priorities among key business stakeholders, responsible to resolve or escalate issues appropriately

• Monitors relationships with Third Party Vendors by close interaction with all parties and acts where (potential) issues may arise. Escalates, applying judgement; goal is to optimize and sustain relationships with the minimal necessary resources

• Provides J&J Leadership recommendations regarding Third-Party Vendor commitments set out in Master Services Agreements supporting J&J Enterprise Pharmacovigilance Activities. Considers, applicable Laws and Regulations, resources, policies and internal company standards.

Qualifications

Education:

• Bachelor's degree with a minimum of 6-8 years of professional experience required

Required:

• Applied knowledge of applicable Law and Regulations governing Pharmacovigilance
• Global experience
• Experience partnering with Regional functions and Third-Party Vendor's
• Demonstrated experience working in matrix environment
• Ability to communicate clearly and concisely in verbal and written form
• Strong negotiation and networking skills
• Demonstrated problem solving ability

The anticipated base pay range for this position in the US is $137,000 to $235,750.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.

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)).

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

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on January 17, 2025. 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.

Johnson & 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.