At Slipstream IT we work to streamline IT Support and provide managed solutions with a strategic consulting and global leadership management approach. Our solutions are designed exclusively for emerging pharma and biotech organizations. Slipstream’s industry-leading solutions free clients from the demands of internal IT and allow them to rapidly advance their mission. Led by a leadership team that has been together for over 10 years, you will join a proven team, culture, and strategy to drive innovation within the IT outsourcing industry while developing your skillset with the opportunities for internal growth.
- Client facing Business Analyst (BA) for the support of Regulatory software applications
- Gather business requirements, develop technical design documentation, design solutions, and configure system enhancements
- Responsible for managing day to day issues and requests
- Supports users in existing Regulatory Submission Management systems ensuring solutions adhere to standard operating procedures
- Technical SME for Veeva Vault Regulatory (RIM) system
- Liaison between business and IT functions
- Drive project activities to completion
- Work collaboratively with cross functional teams, including vendors responsible for managing day to day issues and requests
- Manage project deliverables
- Communicate risk, issues, and formulate viable mitigation plans
- Ensure adherence to industry best practices
- Understanding of or experience working in Regulatory Submission Management functions within pharmaceutical and biotechnology organizations
- 3+ years of experience supporting the Veeva Vault RIM Suite (Registrations, Submissions, Publishing, Archive) in a technical/functional Business Analyst capacity which includes platform updates and configuration enhancements
- 3+ years of relevant work experience in the Life Science and Healthcare industry
- 5+ years of business analyst experience managing validated applications
- Understanding of the Regulatory Submission Management process
- Direct experience with regulated systems or data-driven applications such as Veeva Vault solutions
- Good understanding of GxP and processes to validate an application
- Experience working in a client facing IT role
- Good understanding of SDLC
- Veeva Vault Application Certification is preferred
Slipstream IT is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation or identity, national origin, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Slipstream IT makes hiring decisions based solely on qualifications, merit, and business needs at the time.
This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer.