Veeva

Veeva [NYSE: VEEV] is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, our customers range from the world’s largest pharmaceutical companies to emerging biotechs. Veeva’s software helps our customers bring medicines and therapies to patients faster.

We are the first public company to become a Public Benefit Corporation. As a PBC, we are committed to making the industries we serve more productive, and we are committed to creating high-quality employment opportunities.

Veeva is a Work Anywhere company which means that you can choose to work in the environment that works best for you - on any given day. Whether you choose to work remotely from home or work in an office - it’s up to you.

The Role

Are you a Computer Software Validation (CSV) professional who would like to learn more about clinical trials and Randomization and Trial Supply Management (RTSM) software? Are you an exceptional technical writer with the ability to simplify complex topics?

As a member of the RTSM team, you will work closely with Development and Project Management teams to support customer RTSM implementations in a fast-paced environment. You will use your expertise to take ownership of the validation process for assigned projects and play an important role in building and maintaining product excellence for the RTSM system.

What You'll Do

• Participate in RTSM requirement gathering sessions with clients and RTSM team members
• Closely collaborate with RTSM Development and Project Management teams to ensure requirements are defined in a clear, testable, and compliant format
• Ensure requirements are adequately tested following a risk-based approach
• Develop and maintain CSV deliverables including requirements specifications, test scripts, summary reports, and trace matrices
• Manage Validation testing cycles and resolution of issues and enhancement requests
• Maintain change control documentation to ensure ongoing validation of the RTSM system
• Provide technical expertise to RTSM team members in computer system validation, applicable regulations, and other quality system requirements
• Support customers as needed in RTSM validation activities

Requirements

• 1+ year of experience in a CSV or Software Quality Assurance (SQA) role, life sciences preferred
• Working knowledge of software development cycle (SDLC)
• Working knowledge of GxP Guidance such as 21 CFR Part 11, EU Annex 11
• Strong skills in Microsoft Word and Excel
• Exceptional attention to detail
• Ability to multi-task and prioritize projects in a dynamic, fast-paced environment
• Ability to read and understand complex technical documents
• Good interpersonal skills and ability to communicate in English with team members and customers of varying roles and skill levels

Nice to Have

• Familiarity with the conduct of clinical trials
• Previous experience with RTSM, Electronic Data Capture (EDC), or other software used in clinical trials

Perks & Benefits

• Work from Home
• Flexible PTO
• Medical, Dental, Vision, and 401(k) plans
• Allocations for continuous learning & development
• Fitness and Wellness Reimbursements
• Allocations for donations to the non-profits and charities of your choosing

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Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at talent_accommodations@veeva.com.