Labelling Product Lead
2 days left
- Full Time
An opportunity has arisen for a Contractor Global Labeling Product Leader (GLPL) to support product labeling activities in Janssen R&D as part of the Retrospective Labeling Compliance (RLC) Program in conjunction with the Global Labeling Centre of Excellence (GL CoE). The contract duration is through 31 December 2016 and renewable into 2017 (duration of contract to be determined).
Background and conduct of the RLC Program. One of the primary goals of the RLC Program is to ensure that the safety sections of local product labeling are accurate and up to date to enable safe and effective use of Janssen products, and to ensure regulatory compliance. The initial phase of the RLC Program involved designated RLC staff identifying discrepancies between local labeling in all countries with marketing authorizations and corresponding CCDSs. Subsequent phases now involve remediation activities to document reasons for those discrepancies followed by updating of labeling where deemed necessary. It is in these latter phases where the Contractor's work will be focused.
Responsibilities of the Contractor GLPL. Responsibilities include documenting deviations in accordance with the Janssen deviations process. The Contractor is expected to work independently under the guidance of RLC and GLCoE staff. Following decisions to update labeling, the Contractor will follow established Janssen processes to bring the labeling updates to fruition, managing labeling documents in a document management system. The Contractor may also be asked to lead Labeling Working Groups (LWGs) and Labeling Committee (LC) for consensus and agreement on labeling revisions, assist in issuing CCDS updates, preparing USPIs/EUPIs for submissions, and assist with responses to health authority queries/comments. The Contractor will report to the GL CoE Therapeutic Area Head for Neuroscience/Established Products and will be based in or in close proximity to either the High Wycombe UK or one of the New Jersey/Pennsylvania-based US Janssen office locations. System and business process training will be provided to the Contractor.
Qualifications, experience and skills
- Minimum of Bachelor's degree in a scientific discipline or equivalent.
- Advanced degree (MS, PharmD, PhD, or MD) highly desired.
- At least 5 years' experience in the pharmaceutical industry or health authority, with at least 4 years' experience in regulatory affairs with experience associated with product labeling. Product labeling experience should include authoring text for inclusion in product labeling (CCDS, EUPI, USPI), including drafting text based on scientific source data, supporting rationale, and regulatory requirements, standards and templates, and liaison with subject matter experts and regulatory professionals.
- Advanced Microsoft Word and Excel skills and experience in Documentum-based document management system.
- Excellent project management, verbal and written communication skills.
If you are interested in applying, please click the apply button and write a short note outlining why you are interested and how you think you are suitable. If you have difficulty applying or have any questions, please contact Elise Lambeth on 0207 4400 633. A full job description is available on request.
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