job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you! location: North Chicago, Illinoisjob type: Contractsalary: $53.13 - 62.51 per hourwork hours: 9 to 5education: Bachelors responsibilities:The Manager, Labeling Regulatory Affairs Strategic Labeling, develops and maintains US/EU package inserts and Company Core Data Sheets and coordinates review and approval of these documents with changing regulatory environments. Leads discussions to ensure global consistency of labeling. Educates team members concerning global consistency of labeling.Leads teams on labeling decisions based on knowledge of processes and regulations. Educates others as to new labeling regulations regarding Company core Data Sheet (CCDS), US Package Insert (USPI), Summary of Product Characteristics (SmPC), Structured Product Labeling (SPL), or Instructions for Use ( IFUs)Reviews and assesses data to determine whether accurate and reproducible. Works with clinical and safety teams to assure revised data is included as support documentation following approvals. Provides labeling input for Risk Management Plans, Regulatory Strategic & Tactical Plans (RSTPs) and safety documentsDrives strategic labeling processes within teams based on knowledge of success with other products. Makes recommendations to proactively optimize label language, including effective use of Target Product Label (TPL) and Development Core Data Sheets (DCDS) as applicable, for assigned productsMaintains accurate files of labeling change history and associated documents, including annotations to data sourcesParticipates at team meetings, reviews materials, authors documents and meets timelines. Leads cross-functional teams to resolve labeling issues and address Ministry of Health (MOH) requests globallyWorks with safety groups on safety issues and leads discussion on safety related labeling changes. Makes decisions on own topics and those of direct reports based on experience with various products. Understands and supports regulatory implications of product profile.Works strategically with R&D, Global Medical Affairs and safety to maintain accurate safety profiles for assigned productsWorks with Labeling Operations to ensure quality documents are internally maintained or submitted to FDAProvides labeling support to Asset Development Team (ADTs) and affiliates including pre-approvals, renewals, and competitive analysisMay indirectly manage work of other department members. Assists in training of new personnel and in the development of department processes/policies. qualifications:Required Education: Bachelor's degree in Pharmacy, Biology, Chemistry, pharmacology or related subjectPreferred Education: Bachelor's degree. Certifications a plusRequired Experience: 6 years in Pharmaceutical, regulatory, R&D or industry related area. Experience in labeling or area that could link to labelingAbility to supervise projects and set daily priorities. Able to work in a complex and matrix environmentPreferred Experience: 3 years in pharmaceutical or regulatory preferred. Minimum 3 years' experience in clinical or pharmaceutical preferredCross-divisional team experience and working with cross-functional teamsStrong problem solving with minimal guidance skills: Regulatory Affairs OperationsEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.