Regulatory Operations Specialists II

4 weeks ago


Rahway, United States eTeam Full time

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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