Regulatory Labeling Manager - Remote

Job Description

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Remote CONUS AK HI

As part of Global Labeling (GL), and under the supervision of the Therapeutic Area Lead, the Regulatory Labeling Manager is responsible for supporting the facilitation and management of the end-to-end labeling processes for the pre- & post-marketed products over the product's life cycle. In this vital role you will author, enable internal governance reviews and manage the development of the Target Product Label, Core Labeling documents and USPI in accordance with Amgen Labeling Processes for assigned therapeutic area(s).

Principal Responsibilities Include

Authors and maintains core company labeling documents (including Core Data Sheet, Core Patient Information Leaflet, and Core Instructions for Use) in support of global marketing applications and variations.

Leads the cross-functional Labeling team as a Labeling Strategy subject matter expert for the creation and update of labeling - for alignment and communication of labeling text at product launch.

Authors US labeling documents (including USPI, Medication Guide, PPI, IFU) for the initial Marketing Authorization Application and updates for new indications, efficacy data, product quality changes and safety related topics. Presents to cross-functional and executive level management to obtain endorsement, as appropriate, for the proposed core document and US labeling text.

Leads cross-functional teams (Labeling Working Group) to align on the proposed core document and US labeling text.

Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends across the organization.

Provides consultation to internal and/or external experts on the creation of high quality core labeling documents and manages the dossier annotations within the documents

Provides strategic labeling advice for major regions and works with cross functional teams to ensure that the implementation of global regulatory labeling plans are aligned with global regulatory strategies

Reviews and approves deviations from core labeling; ensures deviations from labeling procedures and policies are addressed appropriately.

Supports preparation of responses to labeling-related Health Authority queries

Incorporates feedback from HF studies into the cIFU (e.g., with incorporation of participants output during the formative/summative studies into the labeling) and associated combination product labeling

Supports the continuous improvement of initiatives across the End to End labeling process.

Supports creation of target product labeling.

Manages the review and approval of core DHCP letters

Regulatory Labeling core member/SME on product-specific Global Regulatory Teams (GRT).

Auto req ID

430217BR

Minimum Education Required

High School/GED

Job_Category

Medical

Additional Qualifications/Responsibilities

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 2 years of related experience

Or

Bachelor’s degree and 4 years of related experience

Or

Associate’s degree and 8 years of related experience

Or

High school diploma / GED and 10 years of related experience

Preferred Qualifications

Demonstrated experience in authoring, developing, and updating Pharmaceutical or Biotechnology product prescribing information labeling

Degree in pharmaceuticals, life science or medicine

Knowledge of prescribing information labeling development within various Therapeutic Areas

Knowledge of FDA, or EMA, or other international regulations for prescribing information labeling with understanding the impact of emerging trends and their implications for Amgen

Project Management experience, experience managing individual and group projects of moderate complexity

Strong collaboration, presentation, communication, interpersonal, and leadership skills

Experience working in a Veeva-based RIM Regulatory Management system

Salary Range

111,939.00 USD - 133,399.00 USD

City*

United States

State*

N/A

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Amgen