Job Detail

Global Labeling Product Leader1800009Y 

Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for a Global Labeling Product Leader. The position will be based at either of the following Actelion sites: US (Cherry Hill, NJ) or Switzerland (Allschwil).This position is open at Manager, Associate Director or Director level. Depending on the profile of the final candidate, the appropriate level will be applicable.

As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.  Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it. Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II-IV, with oral, inhaled and intravenous medications.

Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our 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.

  
Job Responsibilities 

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)

This role may collaborate with internal and external partners

• 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.


• Participates in appropriate representation and influence on industry and trade organizations including those relating to labeling content, processes, compliance and standards.

 
Candidate Requirements

• A University Degree (Bachelor’s degree) in the life sciences.


• An advanced degree (MS, PhD, MD or Pharm D) in the life sciences.


• 4+ years of pharmaceutical industry or health authority experience.


• 3+ years of Regulatory Affairs with experience in product labeling/labeling regulations, or equivalent.


• 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.


• 1+ 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 management 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.

If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your application.

 

Primary Location

: CH-BL-Allschwil

Schedule

: Full-time

Job Posting

: Jun 21, 2018

Job Type

: Standard

Job

: Regulatory Affairs