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Career, Jobs and Resume Groups Forum Index » Jobs U.S.A. » US-IL: Mundelein-Associate Director, Regulatory Affairs (Pub
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| JobCircle.Com |
 Posted: Wed May 23, 2007 4:00 pm |
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Job Title: Associate Director, Regulatory Affairs (Publishing)
Job Location: IL: Mundelein
Pay Rate: Open
Job Length: full time
Start Date: 2007-05-23
Company Name: The Cambridge Group Ltd.
Contact: Stephanie Oscar
Phone: E-mail or fax only
Fax: 203-226-3856
Description: Associate Director, Regulatory Affairs (Publishing)
Incumbent will be responsible for managing the electronic reporting and submission publishing activities for all major global submissions and will serve as an expert lead in monitoring the global regulations relating to submission format and assessing the impact to the organization. Responsibilities include: manage report and submission publishers. Ensure proper resource allocation across multiple concurrent projects; ensure all submission related activities are completed on time; support the transition to eCTD submissions including activities such as the definition of new internal publishing processes, implementation of new publishing software, definition of new cross-functional processes and standards, training of regulatory operations staff, development of internal eCTD expertise, and interpretation of agency guidance documents; work with the capacity planning group to prioritize resources including justification creation for contract assistance to cover the peak submission times; represent Regulatory Operations Publishing on Global Project Teams or Submission teams as necessary, monitor submission timelines against standards; approve the final internal process and standards do
cuments relating to publishing and publishing deliverables; create and finalize external process and standards documents relating to publishing deliverables; work with IT and/or vendor on business problem resolution and enhancements; responsible for assessment of metrics and reporting to Senior Management on monthly basis; serve as the expert lead in the format of regulatory submissions globally; ensure that all appropriate business processes and standards are in place and followed to support global submissions; responsible for the implementation/testing of publishing software updates or enhancements and determining impact of regulations to the software and the business processes that support global submissions. Qualifications include: a Bachelor's degree; a minimum of 5 years experience; Masters degree preferred; prior experience managing a publishing group is mandatory; 5+ years in creation of Global Regulatory Submissions that involved working with customers in planning and construction of very complex submissions including both electronic and paper submissions; extensive knowledge of publishing-related software tools including Documentum, eCTDXpress, CoreDossier, ISI Toolkit,
Adobe Acrobat, MS Word etc; demonstrated analytical capabilities and project management including impact assessment and critical thinking; technical expertise required because of the complex environment that exists to support creation of global submissions; demonstrated leadership capabilities with 4+ years experience managing employees. Travel may be 5%.
Please refer to Job code SD4471 when responding to this ad.
For FASTEST PROCESSING of your resume, please visit http://www.jobcircle.com/classifieds/716530.html?source=ng to apply online.
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For fastest processing of your resume, this employer asks that
you apply to this job using the URL above.
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