Allergan Manager, Global Labeling in Irvine, California
Manager, Global Labeling
Irvine, California, United States at https://agn.referrals.selectminds.com/jobs/7183/other-jobs-matching/location-only
Nov 02, 2018Post Date
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
The Global Labeling Lead (GLL) has overall accountability for the initial creation and updates to labeling documents for the product’s lifecycle. This includesglobal labeling (CCDS/CCSI) and US labeling (prescribing information, patient information and other required labeling components) documents. Development of labeling for these products is based on study results, coordination of labeling review and approval throughout the company, preparation of labeling components for submission to regulatory agencies, and participation in labeling negotiations with agencies resulting in product approvals or labeling updates. The position also includes subject matter expertise in specific labeling regulations (e.g., FDA labeling rules/guidance) and review of international local labels to assure compliance with corporate labeling.
Main Areas of Responsibilities
Provide leadership, guidance, and project management to the Labeling Review Committee (LRC) for the development, revision, review, approval and maintenance of assigned products. Ensure timely distribution of preparatory documentation, identification of issues for discussion, preparation of meeting minutes, and follow-up of action items to complete resolution.
Provide strategic Labeling guidance to authors regarding appropriate content for labeling documents.
Assist in the development and review of international local labeling in accordance with the Company Core Data Sheet
Interact with business partners and global affiliates in providing strategic guidance as appropriate to ensure consistency and compliance of product labeling.
Demonstrate proficient and current labeling knowledge. Invest substantial time to improve competency level in understanding and interpreting evolving FDA regulations and guidance.
Maintain knowledge of applicable corporate/company SOPs, guidelines, and working instructions related to product labeling.
Liaise with US Labeling/Labeling Operations team to ensure compliant product labeling.
Experience drafting and reviewing product labeling and compiling supportive documentation and demonstrate competence in marketed product labeling maintenance.
Basic knowledge of global core data sheet guidance and US regulatory labeling requirements. Relevant experience may include a background in Drug Regulatory Affairs (i.e., FDA liaison) with experience in interpretation of FDA regulations, including exposure to labeling development and maintenance, or a background in medical writing with exposure to FDA regulations as a guide in content development for medical and/or regulatory documentation.
Detail-oriented, well organized and good planning skills.
Excellent proofreading/editing skills are required
Excellent communication (verbal, writing, and presentation) skills necessary for interacting with regulatory project managers and multi-functional labeling review teams.
Graduate degree in scientific discipline, with minimum 1 year labeling or relevant / related experience
Pharm.D. strongly preferred
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.