Global Labeling Lead (465178) Job in Groton, Connecticut US
Global Labeling Lead (465178)
Global Labeling Lead Clinical Research Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have an exciting contract opportunity for a Global Labeling Lead for our client in the following locations: Groton, CT, Collegeville, PA and Bridgewater, NJ. Job Responsibilities (other duties may be assigned): The Global Labeling Lead (GLL) is accountable for initial creation and relevant updates to labeling documents for their assigned products globally. This includes guiding the Labeling Team to facilitate development of source labels e.g. CDS. The GLL will review the downstream impact of source label updates on local product documents (LPDs) in addition to ensuring any associated patient/technical leaflets are updated, regardless of registration procedure. This includes USPIs and Centralized Procedure SmPCs. The GLL ensures that any required updates on LPDs across the globe are properly assessed and proactively managed by the Hub Labeling Manager (HLM). The GLL must ensure these documents are produced in a timely manner according to internal SOPs and meeting external regulatory requirements. The GLL is the primary point of contact for labeling teams and will provide day-to-day direction to Labeling Operations Specialists so that necessary source label documents and decision documentation can be prepared and managed appropriately throughout client processes and systems. This role will keep up to date with labeling regulations and oversee product labeling requirements globally. Additionally the role will have oversight of content messaging across local labels for their assigned products and should support and drive consistency across regions wherever possible. This role will interface with the Labeling Operation Specialist and Hub Labeling Managers, WRS Strategist and Labeling Team members, PCO colleagues, MDL Authors, Global/Regional Medical TA Leads, and Submissions Specialists in the delivery and management of labeling text through appropriate processes and systems to assure the timely submission and ultimate approval of client product labeling across the globe. This role will act as a Subject Matter Expert (SME) on regional and multi-country regulatory labeling requirements and participate in the sharing of intelligence. Requirements: Bachelor degree or above is required. Pharmaceutical industry experience is required. Regulatory labeling experience and knowledge of global regulations required. Must have at least 7 years of patient labeling experience in order to be considered. Candidate must be local driving distance from site they are being considered for Groton, CT, Collegeville, PA, or Bridgewater, NJ. For immediate consideration, click the Apply Now button, or refer a friend by clicking the E-mail this job link provided. Kelly Scientific Resources® has grown into a $270 million global business as the scientific business unit of Kelly Services. Our recruiting consultants place clinical, regulatory and medical affairs, data management and biostatistics professionals to the pharmaceutical, biotechnology, medical device, CRO and university research communities. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com . Kelly Services is an Equal Opportunity Employer.