MAC Reference Librarian

Location: Prakāshamnagar

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 Sci Comm 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 Promo Mats
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