Manager/Sr. Manager, Regulatory Systems - Bothell, WA | Biospace
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Manager/Sr. Manager, Regulatory Systems

Seattle Genetics, Inc.

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Location:
Bothell, WA
Posted Date:
6/26/2017
Position Type:
Full time
Job Code:
1986
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Summary:
 Primary purpose of this role:

   
        
  • Plan, implement and maintain software and systems in support of Regulatory Affairs
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  • Activities include Regulatory application administration, project management, business analysis, end user training, issue identification/troubleshooting, new system installation, report development, ancillary software support, maintenance of system security and performance
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  • Serve as the primary interface with Regulatory system users and vendor contacts
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  • Manage Regulatory system validation projects and other compliance efforts
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 Responsibilities:

   
        
  • Should be familiar with the operation and use of off-the-shelf Regulatory systems relative to document management, electronic publishing, dossier viewing, information management, Regulatory intelligence and analytics, product registration
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  • Serve as liaison with outside vendors during installation, modification, training, and development of Regulatory application software
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  • Serve as liaison with IT, CIS, and QAV groups
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  • Develop and maintain applicable SOPs, work practices and training guides; ensure documents reflect current practices and are consistent across documents
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  • Develop system-specific procedures, programs, scripts, or web pages, as required
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  • Create user documentation and train personnel on applications/reports/solutions, as required
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  • Monitor software requirements, determine application utilization, and recommend upgrades/enhancements, as needed
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  • Monitor and respond to application problems using appropriate problem determination tools; track problem occurrence and resolution; identify, diagnose and repair complex problems; take corrective action to prevent or minimize system issues
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  • Troubleshoot to resolve Regulatory system-related problems; coordinate with relevant IT/CIS staff and/or third party vendors regarding user support and problem resolution
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  • Provide project leadership in planning, design, implementation and support of business applications; ensure interface with existing application, network and operational server environments
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  • Develop and implement operational standards and procedures for Regulatory applications, including those for performance, backup, and security; interface with IT/CIS staff for development and monitoring of off-hours and special procedures
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  • Manage validation processes for Regulatory systems, including creation of appropriate SOPs and procedures, preparation of submittals, audits of system operation parameters
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Requirements


Qualifications:

  • Bachelor's degree, preferably in a scientific discipline, Computer Science or related technical/scientific field, or equivalent experience
  • 5-10+ years of experience in Regulatory Affairs, Regulatory Operations or Information Services in the pharmaceutical/biotechnology industry
  • High level of technical expertise and extensive knowledge of Regulatory applications and support techniques
  • High level of expertise in project management as related to the selection, installation, and management of application software and systems
  • Experience with Regulatory applications involving document management, electronic publishing, dossier viewing, information management, regulatory intelligence and analytics, and product registration preferred
  • Experience with end user training, troubleshooting, and software development assistance
  • Fast paced office environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.