The successful candidate will be results-oriented with concerns for quality and collaboration. They will show initiative and want to continue to develop and acquire new expertise.
Responsibilities of this position will include collaborating across the company, affiliates and alliance partners on an effective and efficient process for the global distribution and tracking of labeling updates for products.
Disseminates and tracks approved labeling documents and supporting documentation across the company and with affiliates/companies and partners for labeling compliance distribution and implementation requirements
Team with Label Strategist to:
Conduct international labeling operations activities to support global new product and supplemental applications to product registration, and post approval launches for impacted international markets.
Collaborate with Technical Operations team members to ensure commercial distribution, Regulatory Technology for labeling submissions, PV for safety reporting, and other functional groups. Provide labeling to Advertising and Promotion for marketing pieces, and with Commercial for website postings if needed.
Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control.
Utilize regulatory/product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines.
Populate and maintain labeling system and if needed external databases. Follows FDA postings on websites e.g. DailyMed, Drugs@FDA to ensure currency.
Responsible for executing and effective quality control reviews and tracking (primarily) internally used labeling documents (Core Data Sheet, Core Patient Information Leaflet, Core Instructions for Use) and outward facing local/regional labeling (USPI, Med Guide, SmPC, PIL, Canadian Product Monograph, Instructions for Use) as well as container and carton labels to meet regional regulatory requirements and ensure consistency between labeling, labels and supportive documents.
Act as operational expert for the Global Labeling tracking in RIMs, SPL generation, ensure development and maintenance of templates, collaboration features and system upgrades
Supports drugs listing and establishment registration
Contributes to the continuous improvement of the end-to-end labeling process including excellent proofreading/editing skills and compiling supportive documentation
Collaborate with the Global Labeling Team to review and monitor safety variation tracking compliance metrics for CCDS related Safety Changes.
· Solid understanding and interpretation of US labeling regulatory requirements preferred
· Solid understanding requirements for tracking
· Solid understanding of the structure of the product labeling
· Solid understanding of the pharmaceutical industry drug development process
· Must deal with ambiguity and be action oriented.
· Attention to detail
· Ability to recognize and escalate issues
· Time management/Planning skills
· Strong written and oral communications and organizational skills
· Problem Solving
· Interpersonal and Negotiation skills
· An aptitude for the use of IT systems; preferable that they have knowledge of Documentum/electronic document management, Regulatory Information Management Systems (RIMS), XML-based and comparative text quality control systems. Proficiency in standard office technology, including Microsoft Word/Suite, Outlook Mail/Calendar and willing to learn additional applications as needed
· Proofreading would also be a responsibility as well as a representative on industry working groups.
· Able to work across multifunctional groups
· The ideal candidate should be action oriented, customer focused, have the ability to manage workloads, and set priorities. In addition, he/she should be capable of dealing with ambiguity, and be comfortable working with multifunctional teams.
· Bachelor’s Degree plus at least 5-6 (Manager) years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
3 openings. Telecommuting is allowed.
Internal Number: 14245
About Pharmica Consulting
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