Merck Global Labeling Lead Sr. Specialist (Remote) in Indianapolis, Indiana
As part of Global Labeling Therapeutic Areas, and under the supervision of the Director Global Labeling Strategy the Global Labeling Lead (GLL) is responsible for managing labeling of assigned products for developmental and marketed products, globally. This includes collaboration with the cross-functional labeling team to develop and maintain the CCDS and US labeling, including associated patient labeling documents, and the target product labeling. The GLL is also responsible for supporting local country affiliates on the development and maintenance of the EU and most of world labeling.
This position is REMOTE with location anywhere in the US.
Responsibilities may include, but are not limited to:
Overall accountability for the initial creation and updates to labeling documents for assigned products including development and maintenance of CCDS, US labeling, and their associated patient labeling documents, and target product labels. Includes the responsibility to work cross-functionally and lead meetings to develop, review and approve labeling documents.
Operates as the primary point of contact on assigned products for all internal and external stakeholders to ensure timely regulatory submissions , quality and compliant labeling documents, and to support business objectives. Includes support required for audits/inspections related to assigned products.
Provides project management throughout the entire process, from the request to update a CCDS/US labeling through notification to stakeholders, in order to ensure documents are produced in a timely manner according to internal operating procedures and external regulatory requirements. Includes the responsibility to manage communication plans, distribution of labeling documents, updates to labeling tracking reports and databases, and providing status updates to Global Labeling management.
Knowledgeable about key labeling requirements worldwide and ensures that country labeling documents are aligned with the CCDS or reference labeling documents.
Provides regulatory expertise and guidance for the development and submission of US labeling components. Controls the consistency of US labeling content through alignment with the CCDS, across product families where necessary, and with all applicable best practices.
Assists with creation/update of local product labeling (EU and most of world) for assigned products and interfaces with Regional Labeling Lead and local country affiliate colleagues to support timely and quality regulatory submissions and approvals globally.
Supports the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals.
Bachelor’s degree in a scientific or medically-related discipline required. Master’s degree preferred.
Minimum of 4 years of pharmaceutical experience or relevant professional experience.
Ability to develop relationships and work well with others in demanding situations with a positive attitude.
Detail oriented, well organized, high project management skills.
Experience facilitating meetings and driving consensus and results.
Excellent leadership, communication (verbal and writing) and collaboration skills.
Proven ability in medical/technical writing.
Experience in Word, Excel and PowerPoint, and document management tools.
Labeling experience (CCDS, US, EU) in infectious diseases or vaccines or other relevant industry experience related to developing regulatory documentation.
Regulatory submission experience.
Process improvement and compliance/quality experience.
Residents of Colorado
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No Travel Required
Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R98328
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