Johnson & Johnson Careers

The Associate Director, Product Vigilance Policy Lead

Warsaw, Poland
Pharmacovigilance


Job Description

Requisition ID: 1905738256W

The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and non-prescription pharmaceutical products.
Our mission is to care for people around the world by developing innovative products and solutions that are grounded in deep human insights, backed by science that is intuitive, and provide irresistible experiences. To support our Worldwide Research & Development operation, we are building a complex R&D support center #Cobic in Warsaw, Poland, to be fully integrated in the global R&D footprint and strategy, helping consumers live healthy and vibrant lives.
 
Associate Director, Product Vigilance Policy Lead
Location: Warszawa, Poland
 
The Associate Director, Product Vigilance Policy Lead is responsible for Product Vigilance (PV) regulation intelligence, tracking global PV regulations, and PV-related external influencing activities., Supports efforts together with internal and external stakeholders to identify and assess emerging regulatory and legislative issues that impact global PV operations and other relevant Johnson & Johnson functions. He/She supports Head of Product Vigilance Policy in leading interpretation and cross-functional impact assessments of new and updated PV regulations.  The scope of responsibilities concerns all classes of consumer products (licensed medicinal products, monographs, cosmetics and where applicable devices). In addition, the Associate Director will be responsible for other operational activities related to PV Policy, including leading and participating in internal working groups as needed.
 
Main Tasks:
  • Enabling proactive compliance with global PV regulations through:
    • Monitoring and triage of new and updated regulations
    • Supporting Regional stakeholders (e.g. LSO & LOC), and leading cross-functional teams to review and assess requirements and identify impact assessment on the global and local PV system
    • Supporting Head of PV Policy in driving interpretation and impact assessment of new and updated global and regional regulations
    • Supporting the coordination of cross-functional teams to review and assess requirements on PV regulations and identify gaps impacting the global and local PV system
    • Supporting Head of PV Policy in providing advice on implementation to appropriate functions and compliance committee(s)
    • Informing Head of Product Vigilance Policy on compliance with implementation of regulations
    • Driving escalation of non-compliance to the functional heads and compliance committee(s)
    • Ensuring all requirements and deliverables/outcomes are documented and retrievable for inspection readiness purposes
  • Tracking and communication activities:
    • Tracking PV regulations globally to review trends and improve OCMS efficiency and organizational effectiveness
    • Collect and report changes and emerging trends in the PV regulatory environment
    • Tracking and providing metrics on PV-related external influencing activities including regulatory commenting on draft PV regulations
    • Developing progress reports on PV Policy activities for senior leaders in OCMS
 

Qualifications

Crucial Requirements for Candidates:

This position is responsible for providing leadership and support in projects, including content, connections with business units and system tools. Skills at assessing data and information, preparing messages, and support execution of strategy are required. The Associate Director must understand global pharmacovigilance regulations and have knowledge of PV-related end-to-end processes within OCMS and internal and external stakeholders and be able to: 
  • Proactively identify issues and problems, can identify and assess risk and the chances of success and offer solutions and recommendations
  • Have ability to work across different businesses and cultures on a worldwide basis to ensure global alignment and compliance with key stakeholders
  • Exercise excellent judgment in assessing priorities and initiating projects

In Return, We Offer

  • An opportunity to be part of a global market leader.
  • A dynamic and inspiring working environment.
  • Many opportunities to work on challenging projects and assignments.
  • Possibilities for further personal as well as professional development.
  • Many employees benefits.
If you are interested in this role or you want to refer a candidate that fulfills the requirements set above, do not hesitate to send us your CV in English via MyNextStep.jnj.com or EmployeeReferrals.jnj.com.

Primary Location
Poland-Mazowieckie-Warsaw-
Organization
Johnson & Johnson (Poland) Sp. z.o.o. (7815)
Job Function
Pharmacovigilance
Requisition ID
1905738256W