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Senior Specialist, Regulatory Labeling

Company

Viatris
Address , Remote
Employment type FULL_TIME
Salary $55,000 - $105,000 a year
Expires 2023-12-11
Posted at 8 months ago
Job Description
1100 Mylan Pharmaceuticals Inc.
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:
  • Access – Providing high quality trusted medicines regardless of geography or circumstance;
  • Partnership – Leveraging our collective expertise to connect people to products and services.
  • Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Every day, we rise to the challenge to make a difference and here’s how the Senior Specialist, Regulatory Labeling role will make an impact:
Key responsibilities for this role include:
  • Maintain current knowledge of U.S. FDA submission standards.
  • Liaise with Quality, as needed, for preparation and submission of artwork files.
  • Ability to quickly master multiple internal software systems in support of labeling submission process such as document control system (D2 or similar system), change control system (TrackWise or similar system), regulatory information management system (Ennov or similar system), etc.
  • Prepares new and revised labeling submission documents and clearly articulate revisions and reason for changes to the U.S. FDA and internally to stakeholders.
  • Plan and coordinate appropriate timepoints to schedule labeling submissions with Regulatory submissions team and assess the published preview of labeling submissions before transmission to the U.S. FDA.
  • Plan appropriate timing for creation and review of Structured Product Labeling (SPL) and associated meta data. Plan appropriate timing for drug listings with internal team.
  • Analyze Prescribing Information and patient labeling to ensure consistency throughout the documents and to ensure consistency with U.S. FDA Guidance and regulations for NDAs.
  • Conduct high level proof-reading capabilities.
  • Prepare and review cover letters and complete FDA fillable forms.
The minimum qualifications for this role are:
  • Normal office situation or remote.
  • 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.
  • Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary lifting requirements.
  • 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.
  • Proficiency in speaking, comprehending, reading, and writing English is required.
  • 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.
  • 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.
  • Ability to perform computations such as percentages, ratios, and rates.
  • 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.
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.
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