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Manager, Regulatory Operations Job
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| Employer Name: BiotechCrossing |
SpiderID: 2298674 |
| Location: Gaithersburg, Maryland |
Date Posted: 6/20/2008 |
| Wage: |
Category: Biotech |
| Job Code: 5470062 |
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Job Description:
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 Collects and interprets global electronic submission guidelines Manages the design and implementation of electronic publishing standards Ensures the organization has the capability to implement fully electronic submissions and is viewed as an industry leader in this technology Works with the organization to implement regional regulations/guidances for electronic submissions and electronic signatures Represents Regulatory Operations on EDMS User Team Manages contract staff in the preparation of legacy electronic and paper documents in accordance with FDA and ICH CTD requirements for inclusion in the electronic document management system. 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.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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