global labeling product leader // johnson & johnson in allschwil

posted
job type
temporary
apply now

job details

posted
location
allschwil, basel-landschaft
job category
Administration
job type
temporary
reference number
129416-26
phone
058 231 57 94
apply now

job description

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Actelion is working to create a world without disease. Actelion is a leader in the field of pulmonary arterial hypertension (PAH). The portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.

The Global Labeling Product Leader (GLPL) will collaborate with functional areas to implement the global labeling strategy in line with the global regulatory strategy. The GLPL will lead the development and maintenance of the following through the company's labeling review and approval processes, ensuring high quality and compliance of labeling documents:

  • Primary labeling documents (Core Company Data Sheet [CCDS], United States Package Insert [USPI] and associated patient labeling, and EU Product Information [EUPI])
  • Derived labeling documents (national comparative documents, labeling text for EU, US and international package components)

Main Responsibilities

  • Have oversight and responsibility for the development, revision, review, approval and maintenance of primary and derived labeling documents for assigned compounds in assigned portfolio
  • Collaborates with subject matter experts (SME) in functional areas (FA) to develop, revise, review, and gain agreement of primary and derived labeling documents through the company's labeling review and approval processes
  • Collaborates with other regulatory colleagues to disseminate company-agreed CCDS, USPI, EUPI and derived labeling documents and supporting documentation
  • Works with other regulatory functional areas to ensure high quality of labeling deliverables (e.g., alignment of labeling text with supporting data, regulatory requirements, consistency between labeling documents)
  • Liaises with third party companies on product-specific labeling-related issues, as required
  • Works with local affiliates/external partners to ensure high quality of local labeling deliverables (e.g., alignment of local labeling with the CCDS, supporting data, and local regulatory requirements) and manages the process and the documentation of local labeling deviations from the CCDS
  • Contributes to the continuous improvement of the end to end global labeling process
  • Provides input to and implements the global labeling strategy including the development of target labeling
  • Provides support during audits and inspections and the management of labeling CAPAs as required

qualification

Who we are looking for

  • A University Degree (Bachelors degree) in the life sciences
  • An advanced degree (MS, PhD, MD or Pharm D) in the life sciences
  • 5+ years of pharmaceutical industry or health authority experience
  • 3+ years of experience in product labeling/labeling regulations
  • Good understanding of worldwide regulatory guidelines and their application to labeling
  • Understanding of competitors labeling in the therapeutic area and labeling content knowledge
  • An understanding of drug development
  • Understanding of life sciences relevant to therapeutic area
  • 3+ years of experience leading teams within a matrix environment with an emphasis on collaborative, customer focused, and learning culture
  • Strong verbal and written communication, negotiation, and partnering skills
  • Expertise in writing pharmaceutical labeling, i.e. optimally expressing the key features of a compound in the labeling
  • Strong Microsoft Word skills and experience working in a document
  • Magement system. Basic Excel and PowerPoint skills
  • Experience in discussing and communicating scientific concepts and engaging in effective collaboration
  • Experience leading continuous improvement projects
  • Demonstrated ability to drive a collaborative and customer focused culture of learning

This role based in Allschwil, Switzerland will initially be limited to approx. 6 months. If you are interested in working for a global leading health care company in a challenging role, then send us your application in English today. Or give us a call if you have any questions!