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1+ months

Global Labeling Lead

Kelly Services
Spring House, PA 19477
Kelly Project Services, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a **Global Labeling Lead** for a long-term engagement at one of our Global clients in Spring House, PA.


This role is a full-time, fully benefited position. As a Kelly Project Services employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. Youll also be eligible for paid time off, including holiday, vacation, and sick/personal time. All Kelly Project Services employees receive annual performance reviews.


**As a Global Labeling Lead placed with Kelly Project Services you will be responsible for the following:**


Development of target labeling, managing the development of updates to Company Core Data Sheets (CCDSs), Centralized/MRP EUPIs, and USPIs in accordance with GL CoE and GRA end-to-end labeling processes. System and business process training will be provided to the Contractor.


**Responsibilities:**

Facilitation of Labeling Negotiations with Health Authorities for EUPI and USPI for Assigned product(s); facilitating LWG review and LC endorsement of labeling documents; preparation and finalization of submission ready EUPI and USPI

Processing Local Labeling Deviation requests for assigned products for ex-US and ex-EU markets, including facilitating LWG review and LC

Preparing updates to the CCDS, EUPI and USPI for products in additional therapeutic areas (for new indications, safety updates, CMC revisions), including facilitating LWG review and LC endorsement of the CCDS and finalizing/releasing the CCDS


**Qualifications, experience, and skills:**

Minimum of Bachelors degree in a scientific discipline. Advanced degree (MS, PharmD, PhD, or MD) desirable. Candidates without a scientific degree but with relevant labeling experience will be considered

At least 6 years experience in the pharmaceutical industry or health authority, with at least 5 years experience in regulatory affairs with direct experience associated with product labeling (prescribing and patient information) is preferred. Candidates with fewer years experience will be considered.

Product labeling experience should include authoring text for inclusion in CCDSs, in addition to EUPIs, and/or USPIs, including drafting text based on scientific source data, supporting rationale, regulatory requirements, standards, and templates, and liaison with subject matter experts and regulatory professionals.

Advanced Microsoft Word skills. Experience working in a Documentum-based document management system. Basic Excel and PowerPoint skills.

Excellent project management, verbal, and written communication skills.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-08-16 Expires: 2021-10-21

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Global Labeling Lead

Kelly Services
Spring House, PA 19477

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