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GxP IT Business Systems Analyst (Remote)

Redwood City, CA · Biotech/Pharmaceutical
Title:  Senior IT GXP Systems Analyst - Veeva

Type of role: 6-12+ Month Contract – Remote

Seeking an experienced IT Systems Analyst with previous Veeva Vault experience. Ideal candidate will have previous system administration experience.

Job Description:
  • Schedule customer meetings, GxP service ticket support, i.e. service tickets, knowledge articles, schedule releases for all GxP applications (Veeva RIM, eTMF, PromoMat, DocuSign Part 11, and in the future QMS and Box)
  • Review day-to-day process for select groups. Analyze and recommend process optimizations.
  • Document to-be process and information flows. Document procedures.
  • Identify stakeholders and capture in detail the problem or issue the stakeholders are trying to solve.
  • Understand strategic business objectives within GxP systems and work with stakeholders to consolidate technical feature requirements.
  • Provide expertise and support to in-flight strategic projects and create run books for long-term support purposes.
  • Collaborate with internal cross functional teams and experts to deliver successfully on user engagement.
  • Actively participate with other members of the delivery team to create solutions that meet business needs.
  • Works with the team to decompose requirements into stories, uncover associated workflows, data and business rules, as well as define acceptance criteria.
  • Learn new concepts, systems, and processes in support of business goals.
  • Develop and participate in the SDLC documentation of business/functional requirements gathering.
  • Schedule and coordinate meetings to communicate direction and assignments of work to be completed.
  • Participate and understand best practices for QA, regression, and UAT efforts.
  • Moves project forward by stepping into other functional roles (testing, iteration management, etc.), when applicable.
  • Helps build standards and best practices.
  • Aligns risk and control processes into day-to-day responsibilities to monitor and mitigate risk, and escalates appropriately.
  • Gather day-to-day functional details to assist with decision making.
  • Communicate progress, issues, and risks to senior leadership.
  • Contribute new ideas to the roadmap.

Primary Skills
  • Experienced Business Analyst with ability to manage dynamic, tight timelines, and wield diplomacy and influence among various personality types.
  • Advanced system analysis skills  and experience with one or all of the following: Veeva QMS, eTMF or RIM. 
  • Previous System Administration experience
  • Must be adept in building document types, workflows, lifecycles, custom objects, and system configurations
  • Strong computer and presentation skills needed (Excel. PowerPoint)
  • A Bachelor’s Degree in Computer Sciences, Pharmaceutics, Chemistry, Statistics, Biology or related field with a minimum of 4 years’ experience in use, management, and/or validation of electronic systems in a GMP environment
  • Working knowledge of Veeva QMS, eTMF, RIM, MS Project, Word, and Excel
  • Strong skills in gathering, defining and refining functional and technical requirements
  • Must possess strong customer service orientation and an understanding of business processes related to pharmaceutical corporate activities.
  • Strong oral and written communication/presentation skills
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