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Manager, Regulatory Operations Job
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| Employer Name: BiotechCrossing |
SpiderID: 2298669 |
| Location: Gaithersburg, Maryland |
Date Posted: 6/20/2008 |
| Wage: |
Category: Biotech |
| Job Code: 5510955 |
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Job Description:
We are a recognized leader in the biotechnology industry. Provides guidance to the organization with respect to electronic and paper submission requirements by working with Regulatory Affairs and project teams, to gather, interpret, and support implementation of submission requirements. Implements regulatory submission publishing and production procedures in addition to publishing documents. Major Duties and Responsibilities: Manages submission publishing activity tasks including production and QC Liaises with Regulatory Affairs and IT partners to ensure the appropriate development of systems, prioritization of issues and training of individuals within the organization on issues pertaining to submission publishing Provides expertise to product teams on the application of electronic submission requirements to their specific submissions Manages compilation of submission outlines and assembly of electronic submissions Coordinates updates and problem-solves issues related to publishing software Monitors agency environment with respect to new guidance and regulations on electronic submissions and subsequently works with the organization to implement changes Assists the Associate Director, Regulatory Operations in all areas of responsibility, including interpreting and enforcing paper and electronic regulatory submission standards, policies and operating procedure requirements. Assists in other regulatory activities as required. Requirements Experience: Minimum of five years overall experience in the biopharmaceutical/biotech industry and at least 3 years of direct experience with regulatory submissions. Strong technical knowledge and working skills of computer software including advanced MS Word features. Experience with publishing tools (e.g., Core Dossier) and with electronic document management systems (e.g., Documentum) within the pharmaceutical industry. Superior organization skills are mandatory. Detail oriented. Job Complexity: Works on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Supervision: Receives minimal instructions on routine work, and more specific instructions on new assignments. Education: Undergraduate degree (scientific discipline or computer science preferable) with a minimum of 5 years of related experience or an advanced degree with 2 year of related experience or relevant experience.
For more information, please click here To visit us at BiotechCrossing.
For further information, please visit us online at http://www.biotechcrossing.com
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: BiotechCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: 91101 |
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Web Site: http://www.biotechcrossing.com
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