Associate Director, Capacity & Performance Management, Pharmacovigilance Operations Job in Horsham, Pennsylvania Us


Johnson Johnson Pharmaceutical Research Development, L.L.C., a member of the Johnson Johnson Family of Companies, is recruiting for an Associate Director, Capacity Performance Management, Pharmacovigilance Operations. This position can be based in any of the following locations: Horsham, PA, Titusville, NJ, Morris Plains, NJ or High Wycombe, UK.

Johnson Johnson Pharmaceutical Research Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

Capacity Performance Management (CPM) is part of Pharmacovigilance Operations within the Global Medical Safety (GMS) function. CPM is responsible for strategic operational capacity management across global case management centers, oversight of operational performance through delivery of operational metrics and an independent quality program, and development of vendor strategies and vendor relationship management with identified suppliers of Pharmacovigilance services.

This position will have a primary focus on capacity management and operational oversight, and may assist with vendor relationship management as identified. Operational performance oversight is focused on facilitation of compliance, efficiency and balancing work load and work demand through development of an innovative forecasting process and metrics dashboards.

The successful candidate will be expected to deliver on the following principal responsibilities: assist in development of overall strategic direction for CPM, and implement as directed, develop and execute strategic solutions for ICSR capacity management, including: develop and execute an innovative ICSR forecasting system in conjunction with key GMS and other Johnson Johnson stakeholders to enhance GMS functionality, develop and execute risk management strategies around ad hoc surges of ICSR volume, including global business continuity for Pharmacovigilance Operations through excellent capacity management models, develop, execute and monitor operational performance metrics/dashboards providing key stakeholders with performance data for business decision support, assist in development of vendor strategies and relationships to enhance capabilities of global Pharmacovigilance services, manage/supervise/oversee CPM staff members as directed and facilitate/participate in internal audits and external inspections in relation to CPM activities.

Key attributes/competencies include strategic thinking, collaboration teaming, organization and talent development, results and performance driven. The position may have people management responsibilities, or may be an individual contributor depending on experience and/or location, and may deputize for the Head of CPM as required.

This position may require up to 15% international travel in support of business needs.

Qualifications

A minimum of a Bachelors degree in a health-related field is required for this position. An RN, PhD, PharmD, MD/MB, ChB or other related scientific or medical degree/qualification is preferred. For physicians, nurses and pharmacists, certification or licensure is required.

A minimum of 5 years of pharmaceutical industry and/or clinical experience with a focus on pharmaceutical safety related areas (including ICSRs and/or aggregate reports) is required. Previous experience in a relevant people or program/project management role is required.

Extensive knowledge and experience with safety reporting and regulatory compliance, and experience in international safety reporting/regulations is required. Experience in global sourcing and vendor management is preferred, as is an understanding of and experience working with and managing projects within a global team environment.

The successful candidate will be able to demonstrate strong leadership skills, including the ability to lead a team especially in a cross-functional matrix environment. The ability to analyze workflow activities across multiple centers to assist in development of resourcing solutions and the ability to evaluate processes and procedures against outcomes to identify methods to improve efficiency, accuracy and compliance is required.

The ability to utilize appropriate initiative and autonomy in achieving objectives is essential for success, as is the ability to work independently and in collaboration with others and to facilitate and lead change. The ability to thrive in a global matrix environment is essential for success in this role. Excellent verbal, written and presentation skills, coupled with good computer skills (e.g. standard MS Office tools, esp. Excel) and a familiarity with safety systems is also required.

This position may require up to 15% international travel in support of business needs.

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