CLINICAL PROJECT COORDINATOR
LAWRENCEVILLE, NJ
Position may start remoted then be onsite 2-3 days a week (expected Oct 2021)
Project Description:
- The candidate will be responsible for assisting in processes related to the Client's TSE (Transmissible Spongiform Encephalopathies) program.
- Develop an in-depth knowledge of global TSE requirements and be able to apply these requirements to the job. Maintain TSE information repositories within the Client.
- Effectively network within key business partners to achieve assigned objectives.
- Evaluate documentation for compliance to current requirements and help with securing documentation for the preparation of the Client's TSE Regulatory Compliance product statements.
Required Skills:
Top 5 must have skills:
- cGMP Knowledge
- 3+ years with MS Office 365
- TSE/BSE Knowledge .
- Biologics experience is preferred.
- Bachelor's Degree
Job Requirements/Education:
- Excellent oral and written communication skills.
- Proficient navigation of electronic systems, (e.g., MS Excel, and Adobe Acrobat) including formatting and electronic management of data and information.
- The candidate must have demonstrated ability to be a strong team member with the ability to drive projects to completion on time.
- Knowledge of global BSE/TSE regulations and guidances a plus.
- Knowledge of product formulation and manufacturing processes desirable.
- Ability to handle multiple projects and prioritize work independently.
- Basic understanding of the drug development process plus an integrated view of the technical, manufacturing and commercial aspects of the pharmaceutical business.
- Minimum of 2-5 years of experience in the pharmaceutical industry with a BS degree in a scientific discipline, chemistry or pharmacy preferred.
- Experience in GMP auditing and/or CMC regulatory a plus.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget:
ALPHA'S REQUIREMENT #21-03014
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
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