Regulatory Affairs Senior Associate

Career Category Regulatory ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world s toughest diseases and make people s lives easier fuller and longer We discover develop manufacture and deliver innovative medicines to help millions of patients Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation using technology and human genetic data to push beyond what s known today ABOUT THE ROLE The Regulatory Affairs Senior Associate role assists US Promotion Regulatory representatives and other cross-functional roles in the administration of regulatory strategies for department initiatives across all product brands This role assists with preparing tracking reporting and archiving US regulatory documentation including preclearance and advisory comment promotional materials and is responsible for all Ad Promo regulated data management This role performs the planning and tracking of all US promotional label changes and manages the system update of promotional labeling and Important Safety Information ISI This role is responsible for US digital labeling and tracks team performance and savings for label change implementation Roles Responsibilities Label change updates and implementation process Logo Package Component Labeling PCL changes Important Safety Information ISI updates Product shot index management of drug product imagery Label change content assessment binders System workflow assessments of label impacted promotional material Regulatory Information Management RIM archiving Preclearance Request for Advisory Comments RFAC submissions Reporting Archiving of Ad Promo FDA Communications i e Intent to Comply Record of Contact -ROC Prescription Drug Marketing Act -PDMA Dear Healthcare Provider -DHCP letters etc Veeva data entry retrieval and collection of information Process documentation authoring support Required Knowledge and Skills Exhibits a professional manner in dealing with others and maintains constructive working relationships Communicates effectively both verbally and in writing with superiors colleagues and individuals inside and outside the Company Can be depended on to complete work in a timely accurate and thorough manner and is conscientious about assignments Ability to read and understand written instructions and follow documented process Ability to lead and manage video conference meetings i e MS Teams and provide meeting minutes Proficient in MS Word Excel PowerPoint Visio and to manipulate data using formulas in Excel spreadsheets including pivot tables Technical editing of process documents and proofreading with the ability to create Infographics slides Experience in Veeva PromoMats to create Electronic Common Technical Documents eCTD compliance packages for US FDA submissions with a strong knowledge of FDA eCTD publishing tools Knowledge and experience in the US Medical Legal and Regulatory MLR review process within Veeva PromoMats to complete Abbreviated Reviews Veeva system expertise in the Records Information Management RIM Vault to archive maintain complaint US Health Authority records MS SharePoint Teams expertise to collaborate and help manage department records process documentation MS Outlook inbox management including organizational skills creating email rules and standard email templates Preferred Knowledge and Skills Previous Amgen or other biopharmaceutical companies experience with US Regulatory Advertisement Promotional Ad Promo expertise Previous SharePoint experience navigating and maintaining document records Veeva Business Admin certified PromoMats RIM US Regulatory Ad Promo Project Management and knowledge of FDA promotional regulations Experience in US labeling and Regulatory document management promotional review and approval processes Basic Education and Experience Master s degree and 4 years of related experience OR Bachelor s degree and 6 years of related experience Preferred Education and Experience Bachelor s degree and 6 years of related experience Experience working in a Global Regulatory Affairs organization AIN working hours for this position This position supports the Regulatory Promotion and Material Compliance activities serving Amgen s US Business Operations and thus the AIN working hours will need to be flexible with occasional overnight work time when needed to support product launches and new indications EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment Please contact us to request an accommodation