Manager, Regulatory Operations Job

Employer Name: BiotechCrossing	SpiderID: 2403414
Location: Gaithersburg, Maryland	Date Posted: 7/29/2008
Wage:	Category: Biotech
Job Code: 6640464

Job Description:
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/guidance\'s for electronic submissions and electronic signatures * Represents Regulatory Operations on User Team * Manages contract staff in the preparation of legacy electronic and paper documents in accordance with and 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.

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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

City: Pasadena
State: California
Zip:

Web Site: http://www.biotechcrossing.com