OPENINGS: Fulltime Regulatory Affairs Manager/Directory SME

SME (Subject Matter Expert) Regulatory Affairs Manager

Job Description:

First Consulting Group (FCG) is a provider of enterprise technology
services, products and solutions to the Healthcare and Life Sciences
community. We provide Enterprise Content Management Solutions (ECM)
which can enhance productivity and boost ROI. We offer FirstDoc®, the
only suite of products that offers full enterprise functionality in an
out-of-the-box, regulatory-compliant solutions.

Job Requirements: Minimum Bachelor's Degree and 5 years direct
experience in Regulatory Submissions. Pharmaceutical and/or BioTech
experience is required along with an understanding of documentation
needs of an electronic FDA submission as well as the business processes
surrounding such a submissions. Management level experience preferred.
Strong communication, presentation and computer skills are required
along with excellent documentation skills. The position involves
requirements gathering through workshops and interviews followed by the
development of specification documentation for technical customization
of systems. Travel to our client sites is 50%. Telecommute is 50%.
Pluses are some experience in the QA/QC (GMP) arena, knowledge of
Documentum and Document Imaging system(s) and/or commercial or clinical
labeling experience.

Residence: Any location Continental US (prefer CA, PA or NJ)


For more information please contact or send information to:

Madeleine Kelly
Life Sciences
First Consulting Group
www.fcg.com
610-989-7292 (voicemail)
484-494-6211 (direct)

.

Relevant Pages

  • Re: convincing a client to go with dotNet instead of Access project
    ... That would be good documentation to have... ... > -learning curve for language, APIs, deployment management, etc ... > -Access really tops out with performance after six concurrent connections ... >> I believe a dotNet solution is better, but I'm trying to be as ...
    (microsoft.public.dotnet.general)
  • Re: The list of INVOKEs
    ... IIRC I think Richard codes HTML documentation in his COBOL ... The poor management MAY be on the part f the Consortium, ... illustrious these contractors may be), if those contractors are NOT well ... Insurance company was very well managed and they had independent consultants ...
    (comp.lang.cobol)
  • Re: How do i write Set based queries and avoid a cursor?
    ... it involves a product or service they are libel for? ... considered an "uninteresting attribute" by management or the lawyers. ... improve the quality of the documentation in just a few minutes: ... Imagine a DB app that calls a webservice to check address against postal ...
    (comp.databases.ms-sqlserver)
  • Re: About PDM Software.
    ... > all our engineering data. ... IIRC MKS used to do concurrent ... considering automating the management of the information. ... All documentation should be subject to the ...
    (comp.arch.embedded)
  • Re: Knowledge Management on the Windows Platform
    ... They will sell me a knowledge management system, ... somewhere behind the technology that Microsoft exposes to the generic user / ... In that documentation would be explained the utility value, ...
    (microsoft.public.windowsxp.general)