Role Description:
Reporting to the VMRD ZTD Regulatory Affairs Lead, this role will be responsible for providing expertise in understanding the working elements, with emphasis on the underlying data, for the suite of applications used to support the VMRD Global Regulatory Affairs area. This knowledge will be used to ensure the reliability of the data used to support these key business functions, to ensure the stability of the applications that rely on such data, and to help shape the future direction of the solutions provided to the business areas.
Responsibilities:
- Be a key resource for understanding the working elements of the Global Regulatory application portfolio, including: vendor and in-house applications, associated databases, data sources, upstream and downstream movement of associated data, automated reporting of data to (and acknowledgements from) multiple regulatory agencies, and reliance on foundational technologies
- Design and/or implement complex changes to Regulatory applications, and/or underlying databases, that require a high degree of technical understanding
- Ensure that ZTD SOPs are adhered to and that the application suite remains in a documented state of control
- Prepare technical documentation needed for the SDLC milestones for Global Regulatory applications
- Work with other groups within ZTD that manage infrastructure elements that support Regulatory applications, as well as up and downstream applications to address problems and or needed changes or additions to such services or applications
- Work with business users to implement and test releases prior to production rollout
- Work with external application vendors to diagnose and solve issues found within the applications
- Serve as Level 3 support and be a resource for consultation for technical questions from application support resources, as needed
- Ensure maintenance scheduled is pre-approved and acknowledged by impacting business teams
- Provide input for business analysis conducted on behalf of the Global Regulatory area
- For new applications, or major upgrades, assist with the application knowledge transfer to primary support team prior to implementation
Qualifications:
- Bachelor’s degree related to information technology, computer science, or relevant field
- Experience with TrackWise based workflow applications – including configuration updates, interface/automation development, instance migrations and TrackWise API – ideally within a Regulated Product business environment
- Experience with Alteryx ETL tool – data interface and report development
- Crystal Reports – design and development
- Experience in the Pharmacovigilance business area is a plus
- Experience with implementing validated applications and maintaining them in a state of control
- Experience with implementations utilizing vendors and/or internal departments
- Experience with system administration and configuration
- Excellent interpersonal and communication skills with the ability to build relationships
- Ability to prioritize issues and drive progress in ambiguous situations
Technical Skills:
- At least 3 years of experience with:
- TrackWise software, including TrackWise API
- JAVA
- Alteryx
- Relational database knowledge
- Crystal Reports
- Informatica experience is preferred
- Business Objects - optional
- Experience with off-the-shelf systems configuration and management
- Experience with system integration and API tools
- Training in TrackWise software
Travel Requirements: 0-10%
The following base pay range reflects the anticipated base pay for this position if a selected candidate were to
be located in Colorado. Base pay may vary based on location and other factors.
Base Pay Range: $91,000 - $131,000
The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in California, NJ Remote, NY Remote, or Washington. Base pay may vary based on location and
other factors.
Base Pay Range: $96,000 - $148,000
This position is eligible for short-term incentive compensation. The position is also eligible for long-term incentive.
We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and
retirement savings benefits along with paid holidays, vacation and disability insurance.
Full timeRegularColleague
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