Business Analyst – Veeva CTMS & QMS (Medical Affairs)

Job Title: Business Analyst – Veeva CTMS & QMS (Medical Affairs) Location: Basking Ridge, NJ Department: Medical Affairs / Clinical Systems Reports To: Director, Medical Operations or IT Business Partner – Medical Affairs Job Summary: We are seeking an experienced Business Analyst with hands-on expertise in Veeva Vault Clinical (CTMS) and QualityDocs/QMS to support Medical Affairs operations. This role will serve as a critical liaison between Medical Affairs, Clinical, Quality, and IT teams to ensure the successful implementation, optimization, and ongoing support of Veeva systems aligned with Medical Affairs processes, including clinical trial visibility, document control, training, and compliance. Key Responsibilities: 🔹 Business Analysis & Stakeholder Engagement • Collaborate with Medical Affairs stakeholders (e.g., MSLs, Med Info, Medical Directors) to elicit, analyze, and document business requirements. • Conduct gap analyses of current vs. future state workflows related to IITs, SOP management, training, and documentation. • Facilitate cross-functional workshops to ensure alignment between Medical Affairs, Clinical Operations, Quality, and Regulatory teams. 🔹 System Implementation & Support • Work with technical teams and Veeva administrators to configure, test, and deploy Veeva CTMS and QMS solutions tailored to Medical Affairs needs. • Support document lifecycle management (SOPs, WI, standard response documents) in Veeva QMS or QualityDocs. • Assist with configuration of Investigator-Initiated Trial (IIT) workflows and tracking in CTMS. • Support the development of role-based access, lifecycles, workflows, and controlled vocabulary aligned with compliance standards. 🔹 Validation & Testing • Write user stories, functional specifications, and test scripts. • Coordinate and participate in User Acceptance Testing (UAT), defect management, and validation documentation. • Ensure solutions are compliant with 21 CFR Part 11, GxP, and internal SOPs. 🔹 Training & Change Management • Support creation of user guides, SOPs, training materials, and job aids. • Conduct end-user training and onboarding sessions for Medical Affairs team members. • Partner with Quality and Compliance teams for audit readiness and training record management. Required Qualifications: • Bachelor’s degree in Life Sciences, Information Systems, Business Administration, or a related field. • 3–7 years of experience as a Business Analyst in the life sciences/pharmaceutical/biotech industry. • Hands-on experience with Veeva Vault CTMS and Veeva QualityDocs/QMS. • Strong understanding of Medical Affairs processes, including IIT management, Medical Information, and SOP control. • Familiarity with GxP, 21 CFR Part 11, and other compliance requirements. Preferred Qualifications: • Experience supporting Medical Science Liaisons (MSLs) or Investigator-Initiated Research (IIR/IIT) workflows. • Prior involvement in Veeva Vault implementations or migrations. • Knowledge of integration between Veeva modules (e.g., CTMS, CRM, PromoMats, RIM). • Experience with tools like JIRA, Confluence, Visio/Lucidchart, or similar.