Senior Labeling Specialist

Mylan Inc.

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.

We have been included on number of award lists that demonstrate the impact we are making.

Every day, we rise to the challenge to make a difference and here’s how the Senior Labeling Specialist role will make an impact:

Key responsibilities for this role include:

• Prepares 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.

• Preparation and submission of original or revised labeling documents to FDA, as appropriate. Must demonstrate ability to independently research projects and engage appropriate departments/subject matter experts to finalize labeling that is accurate and meets regulatory requirements. 

• Ability to review Company Core Data Sheets and assess 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.

• Demonstrates the ability to complete/execute standard labeling projects independently and demonstrates ability to complete these projects expeditiously while maintaining high quality output.

• Responsible for leading/completing extraneous special projects outside of the realm of standard submissions to FDA, as assigned.

• Demonstrates ability to master 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. Demonstrates the ability to independently interpret new guidances and impact on Company’s portfolio.

• Performs other duties as assigned.

The minimum qualifications for this role are:

• Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience.  However, a combination of experience and/or education will be taken into consideration. 

• A 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 as well as possess an understanding of related medical terminology.

• Must have excellent project management skills, ability to manage several different projects simultaneously (with varying degrees of complexity), strong work ethic, consensus gathering skills, and strong written and verbal communication skills. Must be well organized, demonstrate exceptional attention to detail, and be capable of providing support to others. Applicable computer skills in a Microsoft Office-based environment are also necessary, along with 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.

• Typically sitting at a desk or table.

• Hybrid office.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $55,000 - $105,000.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.