MAC Reference Librarian

Hyderabad, Telangana
Permanent
Full-time

2 months ago

Career Category RegulatoryJob DescriptionABOUT AMGENAmgen 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 ROLEThe MAC Reference Librarian will be responsible for managing the digital Reference Library and Match Text Library within the Veeva Global PromoMats system, while adhering to internal guidelines, SOPs (Standard Operating Procedures), policies and industry regulations.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 experienceORAssociate’s degree and 10 years of related experiencePreferred 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 STATEMENTAmgen 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..

Amgen

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