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Job Title: Sr CDMA Submission Manager
Job Location: NJ: Livingston
Pay Rate: Open
Job Length: full time
Start Date: 2008-09-15

Company Name: The Cambridge Group Ltd.
Contact: Stephanie Oscar
Phone: E-mail or fax only
Fax: 203-226-3856

Description: Sr CDMA Submission Manager



The incumbent to the Senior CDMA Submission Manager will plan, lead and coordinate tasks supporting the timely delivery of high quality documents for NDAs/MAAs or complex sNDAs/Type II Variations to Health Authorities (HA) and for related follow-up activities (e.g. 120-Day Update Reports (120DUR), Answers to HA Questions, Briefing Book, Oral Explanation and Advisory Committee), as well as to manage the logistical aspects of building the clinical sections of a submission dossier; in addition, to coach or mentor less experienced Clinical Submission Managers. Duties include: to function as submission expert for the Oncology Business Unit (OBU); primary contact for operational submission related activities for assigned brand(s), responsible for all activities related to the development and internal approval of high quality submission documents (e.g. SCS, SCE, CO, 120DUR, etc.) in collaboration with the CPL/BSL who retain the accountability; these activities are performed according to internal and external guidelines, strategic timing and brand