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Qualifications:
Title: Regulatory Affairs US Biologicals labeling specialist
Minimum Education: Associate degree.
Preferred Education: Bachelor/Master's degree in Life Science.
Required Experience and Skills:
• With Associate, minimum 3-5 years of relevant experience within pharmaceutical labeling experience.
• With Bachelor's, minimum 0-3 years of relevant experience within pharmaceutical labeling experience.
• With Master's minimum 0-2 year of relevant experience within pharmaceutical labeling experience.
• Require someone with scientific background or familiarity with medical terminology.
• Require someone with excellent proofreading skills.
• Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook,SharePoint, ADOBE.
Preferred/nice to have: Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology
Note:
• Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day can be discussed when on assignment.
Responsibilities:
Merck Animal Health is a Biotechnology Center of Excellence that manufactures, fills, packages, and distributes vaccines for animals.
This position is responsible but is not limited to the following duties:
• Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance.
• Support regulatory filing submissions with the USDA for both domestic and international product packaging.
• Independently work with internal stakeholders, regulated packaging processes and system workflows to revise or draft new packaging for vaccine biologicals for both US (domestic) and international markets.
• Ensure prompt availability of labels and artworks and liaises with departments such as Marketing, Pharmacovigilance and Technical Services to ensure compliance with established regulations.
Full Time
$72k-93k (estimate)
06/21/2024
07/08/2024
merck.com
KENILWORTH, NJ
>50,000
1891
Public
KENNETH C FRAZIE
$10B - $50B
Pharmaceutical
Merck is a New Jersey-based global pharma company that develops and manufactures prescription medicines, novel vaccines, biologic therapies and animal health products.