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Documentation Management Associate

Location: NJ
Industry: Pharmaceutical/Biotech
Job Code: 12024-10

This position’s responsibilities include but are not limited to, receiving essential document/information that has been transmitted to RA document management group and has the experience to know (or learn) how it should be filed & maintained, manages the lifecycle of that information (records management), and archives essential documentation in compliance with health authority regulations/guidance

Position Breakdown and Responsibilities:

40% - Ensure critical documents are being maintained according to company's Records Management Policy, Code of Federal Regulations 21CFR11 and 21CFR312.57; International Conference on Harmonisation E6, as well as EU Good Clinical Trials Directive 2001/20/EC (Article 16) and EU Good Clinical Practice Directive 2005/28/EC (Chapter 4), in order that the company is prepared in the event of regulatory inspection.

20% - Assist in the development of Regulatory Department’s processes for product lifecycle management and pharmaceutical documentation management.

20% - Assist in preparation of major regulatory filings, including US IND, NDA and eCTD submissions, as well as international dossiers.

15% - Monitor multiple regulatory/pharmaceutical sources on an ongoing basis to obtain regulatory intelligence information, which will include but is not limited to searching for new/revised legislation, maintaining a repository, and disseminating information to senior regulatory personnel for assessment.

5% - Assist in the review and acquisition of document/records management software for secure and instant access to incoming essential documentation as well as create a searchable repository for legacy documentation.

Education and Experience:

• Requires 3 years pharmaceutical with at least 3 years of computer operation focus
• Familiarity with regulations and health authorities
• Experience with Web-based technology; familiarity with software validation
• Detail oriented and highly organized; experience and judgment to plan and accomplish goals; perform a variety of tasks; flexible and patient; strong interpersonal skills; good written and verbal communications

 

Contact:

For more information on this or any of our other available positions or to be contacted by one of our staffing specialists, please send us your resume, cover letter and RegExec job code to resume. Attention: Steve Theodorovich.

PLEASE NOTE: All resumes that are received by RegExec will be thoroughly reviewed by one of our staffing specialists and treated confidentially.