MAC Reference Librarian

Roles & Responsibilities:

• Manage Reference and Match Text Libraries for multiple US MAC Teams
• Adding new Match Text records and adjusting existing records.
• Manage Amgen Label Reference documents in Veeva
• Organize annual reviews
• Supports Global Initiative/Other MAC related projects.
• Expert in MAC Reference Requirements and Veeva Reference & Annotation (R&A) technology.
• Performs Quality Check on all References uploaded into the Reference Library to ensure aligned to R&A requirements
• Builds & maintains strong relationships with project Sponsors (owners), Reviewers, agencies, and other MAC Cross functional partners while also providing training on Reference Library and Linking requirements & identify Reference QC issues
• Collaborates with Material Compliance Managers (MCM) to understand BU/Product business priorities and elevate process issues that arise
• Collaborates with MCA to identify and correct Reference QC issues
• Partners with SciComm to update Links to Reference Anchors in MAC materials
• Manage the MAC Reference Library email Inbox.
• Create and manage associated work instructions.
• Facilitate weekly Reference Library Office Hours
• Reports to the Director of Material Compliance in Regulatory Affairs

Required Knowledge and Skills:

• Ability to foster collaboration, work effectively on cross-functional teams, and consistently deliver on-time.
• Strong oral and written communication skills; strong interpersonal skills; demonstrated time management and decision-making skills.
• Critical thinking and problem-solving skills
• Quick learner, proactive, takes initiative.
• Distinguishes proper balance between strategic and tactical thinking.
• Strong experience with Project Management tools, methodologies, and practices
• Proven ability to manage in a highly fluid, interactive, matrix environment.
• Authoritative command of complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analysis and influence decision-making.
• Identify continuous process and system improvements to save time and cost to Amgen.

Preferred Knowledge and Skills:

• An understanding of the pharmaceutical commercialization process and knowledge of the legal and regulatory guidelines affecting promotion of prescription products
• Project management experience in the Pharmaceutical, Biotechnology or other Healthcare-related field, or other regulated industries
• Experience with Microsoft Office 365 (e. g. Word, Excel, Outlook, and PowerPoint), Adobe products (e. g. Adobe Photoshop, Illustrator, and Acrobat Pro), and Veeva PromoMats
• Experience managing medical reference support for marketing materials that are produced at high volumes.
• Experience managing digital library and medical references.

Basic Education and Experience:

Bachelor s degree and 6 years of related experience

OR

Associate s degree and 10 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

Skills Required
Cataloging, reference services, digital literacy , Research Skills, Information Retrieval