Job Title: IT R&D Consultant Job Function: Business Analyst Location: Brisbane, CA - Hybrid
About USDM
USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job
Resource will support maintenance and enhancement of IT R&D systems. The ideal candidate will be well versed in ITSM and IT Change Management, have technical experience in managing IT R&D Systems as well as experience in Business Analysis, Project Management, Release Management and Production Support of hosted and SaaS IT R&D systems.
Primary Responsibilities
- Work with the IT R&D lead to establish and maintain IT Roadmaps by aligning with business teams on new demand, provide updates on existing projects. Ensure initiatives are delivered on time and within scope.
- Lead System Maintenance and Enhancement (M&E), understand new M&E requests from the business.
- Perform impact assessment on existing functionality and design and prioritize new system enhancement requests for sprint planning
- Review technical specifications and design and provide technical feedback to ensure solution is scalable and optimal
- Oversee end-to-end system implementation from a functional and technical standpoint and work with vendor to resolve issues
- Collaborate with BSO and project team on roll-out planning by understanding dependencies, approving the release plan, managing the IT Change Request, and driving the overall implementation process
- Ensure timely support and resolution of production issues by performing initial analysis and triaging issues and support tickets
- Coordinate and work with IT Compliance to ensure GxP compliance on all initiatives.
- Work with vendors to perform requirements walkthrough, technical reviews, testing in Production and non-Production environments
Additional Responsibilities
- Performs other related duties and assignments as required
Qualifications
- 4+ years of relevant experience working with Clinical and Regulatory IT R&D systems. Hands-on experience with the following systems is required:
- Veeva Vault RIM - Registrations, Submissions, Submissions Archive and Publishing
- Veeva Clinical - eTMF, CTMS and Payments
- Experience working with ServiceNow, Okta and working knowledge of MuleSoft middleware
- Veeva certified Vault owner training and experience is highly recommended.
- Ability to provide solutions at a technical level and review technical solutions recommended by vendors.
- Experience in business processes for clinical and regulatory systems.
- Proficient with relational databases and reporting tools (e.g., PowerBI,).
- Experience with System Development Lifecycle (SDLC) in a regulated environment including integrations using APIs
- Track record of leading multi-level, cross-functional teams (including vendors and MSPs) within a matrix environment to deliver complex IT initiatives with minimal oversight.
- Experience in pharmaceutical industry preferred
- Strong knowledge of GxP systems and their requirements. Experience with testing applications based on requirements needed.
- Excellent analytical skills for requirements analysis and proven ability to troubleshoot issues independently and prioritize steps in delivering solutions.
- Good organization skills, ability to manage multiple tasks.
- Must communicate clearly and effectively with both technical and non-technical stakeholders, including remote teams.
Education & Certifications
- Bachelor’s degree in Information Technology, Computer Systems, Information Systems or related field from a 4-year accredited institution.
Working Conditions
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
- Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
- Operate other office productivity machinery, such as a calculator, scanner, or printer.
- Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Equal Opportunity Statement
USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Compensation
Salary/Hourly Rate Range (W2): USD 75.00 - 85.00
The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.
Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.
Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.
All employees are eligible for USDM's rewards and recognition program.
For more details about our benefits, visit us here:https://usdm.com/careers/
