Senior Labeling Specialist

Viatris•Washington, DC

1d•$55,000 - $105,000•Hybrid

About The Position

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. The Senior Labeling Specialist role will prepare new and revised product labeling for ANDAs, NDAs and BLAs. This includes preparing original labeling or revising existing labeling in response to FDA comments/guidances/regulations, changes in Reference Listed Drug (RLD) approved labeling, or in support of launch and/or rebranding activities. This role involves the preparation and submission of original or revised labeling documents to FDA, as appropriate. The specialist must demonstrate the ability to independently research projects and engage appropriate departments/subject matter experts to finalize labeling that is accurate and meets regulatory requirements. They will review Company Core Data Sheets and assess the impact to the US Prescribing Information and associated labeling documents. The role requires interaction with multiple departments within the Company, as well as third parties, to create labeling that meets regulatory, legal, and commercial/marketing requirements. A strong working knowledge of FDA’s “Orange Book” with regard to patent and exclusivity information for RLD that affect the labeling for Company’s applications or products is essential. The specialist will lead/complete extraneous special projects outside of the realm of standard submissions to FDA, as assigned. Mastery of internal software systems in support of the labeling submission process, such as D2 and TrackWise, is expected. The role may serve as a departmental superuser/subject matter expert (SME). Maintaining current knowledge of FDA regulations and guidances pertaining to labeling by utilizing the FDA website and via attendance at conferences is crucial. The ability to independently interpret new guidances and their impact on the Company’s portfolio is required. Other duties as assigned.

Requirements

Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience. A combination of experience and/or education will be taken into consideration.
Strong understanding of the United States Pharmacopeia, Title 21 of the Code of Federal Regulations, various FDA Guidances for Industry, along with knowledge of the regulatory process pertaining to drug labeling.
Possess an understanding of related medical terminology.
Excellent project management skills.
Ability to manage several different projects simultaneously (with varying degrees of complexity).
Strong work ethic.
Consensus gathering skills.
Strong written and verbal communication skills.
Well organized.
Exceptional attention to detail.
Capable of providing support to others.
Applicable computer skills in a Microsoft Office-based environment.
Working knowledge of TrackWise and D2.
Position functions semi-independently.
Ability to read and interpret complex business and/or technical documents.
Ability to write comprehensive reports and detailed business correspondence.
Ability to work with groups of people such as other departments and communicate known concepts.
Ability to present to a group of departments.
Ability to perform computations such as percentages, ratios, and rates.
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.
Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

Responsibilities

Prepares new and revised product labeling for ANDAs, NDAs and BLAs.
Prepares original labeling or revises existing labeling in response to FDA comments/guidances/regulations, changes in Reference Listed Drug (RLD) approved labeling, or in support of launch and/or rebranding activities.
Prepares and submits original or revised labeling documents to FDA, as appropriate.
Independently researches projects and engages appropriate departments/subject matter experts to finalize labeling that is accurate and meets regulatory requirements.
Reviews Company Core Data Sheets and assesses the impact to the US Prescribing Information and associated labeling documents.
Interacts with multiple departments within Company, as well as third parties, as appropriate, to create labeling that meets both regulatory, legal and commercial/marketing requirements.
Develops and maintains a strong working knowledge of FDA’s “Orange Book” with regard to patent and exclusivity information for RLD that affect the labeling for Company’s applications or products that Company distributes under another company’s application.
Completes/executes standard labeling projects independently and expeditiously while maintaining high quality output.
Leads/completes extraneous special projects outside of the realm of standard submissions to FDA, as assigned.
Masters internal software systems in support of the labeling submission process, such as D2 and TrackWise, etc.
May serve as departmental superuser/subject matter expert (SME).
Maintains current knowledge of FDA regulations and guidances pertaining to labeling by utilizing the FDA website and via attendance at conferences.
Independently interprets new guidances and their impact on Company’s portfolio.
Performs other duties as assigned.