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Job Title:     Product License Support Manager
Job Location:  NY: New York
Pay Rate:      Open
Job Length:    over 1 year (contract)
Start Date:    2012-11-03

Company Name:  Klein Management Systems
Contact:       David Klein
Phone:         email only
Fax:           email only

Description:   Product License Support Manager

        This is a support role, not a Project Manager level position

                Description:

                        A Product License Support will ensure Pharmaceutical maintains compliance by delivering the portfolio of one or multiple applicable regulatory obligations.                     Product License Support Group comprises coordination of regulatory compliance starting at drug development stage and reaching through the lifespan of the Product.                      Members of this team hold responsibility for verifying presence and consistency of required investigator related documents in the electronic Trial Master File facilitating the release of Pharmaceutical sponsored investigational medicinal product.  Additionally, following submittal of an initial IND, members of the team have accountability for compilation and submittal of IND Annual Reports. Once a New Drug Application is approved, a host of activities are required to set up and maintain the new drug label and essential product information (known as drug listing data) to Pharmaceuticals website and FDA, the National Library of Medicine (Daily Med) Website and the Drug Registration and Listing System team.                       Compliance activities continue with coordination of information in support of New Drug Application Annual Reports and NDA Periodic Reports. In addition, members of this team support submittal of advertising and promotional materials.                       Team responsibilities also include managing the coordination of regulatory ancillary documents (including legalization) and drug samples to support registration and approval products in International markets.

        Requirements    

                        Undergraduate degree plus relevant experience as below                  Demonstrated ability to function autonomously in a matrixed environment.                        Knowledge of Regulatory compliance requirements, processes and systems, preferred but not required                      Demonstrated Project Managements Skills: Competent illustration of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.                      Strong Technical skills

Please refer to Job code 12-00512 when responding to this ad.

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