Regulatory Operations Specialists
3 weeks ago
Regulatory Operations Specialists - II (Associate)
Rahway, NJ- Hybrid
schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day is optional.
12 Months contract
Pay Rate: $26.56/hr on w2
•Under general supervision, responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA).
•Ensure that product labeling is updated in accordance with FDA regulations and corporate guidelines.
•Ensure prompt availability of labels and artworks and liaises with departments such as Marketing, Pharmacovigilance and Technical Services to ensure compliance with established regulations.
•Maintain databases and team sites by ensuring updated and accurate information is uploaded.
Quals
Title: Labeling Specialist within Animal Health
Education: Associate/Bachelor of Life Science/Master's degree.
Required Experience and Skills:
•With Associate, minimum 5 years of relevant experience within pharmaceutical labeling experience
•With Bachelor's, minimum 3 years of relevant experience within pharmaceutical labeling experience
•With Master's minimum 2 years of relevant experience within pharmaceutical labeling experience
•Require someone with scientific background or familiarity with medical terminology.
•Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, and SharePoint.
•Excellent English oral and written communication skills and presentation skills.
•Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology
Personality:
•Attention to details
•Team Player
•Can work independently
•Excellent communication and written skills
Note:
•1 year assignment with possibility of extension
•Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day is optional.
•Manager will prefer someone with experience over a degree/education.
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