Associate Director IT Applications

Role Summary

Associate Director IT Applications responsible for planning, implementing, managing, administering, and supporting validated business applications across Clinical Development, Clinical Operations, Biostatistics, Regulatory, Drug Safety, and Pharmacovigilance. Lead identification and implementation of new validated software to support business growth. Based in Waltham, MA; office-based employees work in the office three days a week.

Responsibilities

• Collaborate with IT Leadership to plan and implement validated business applications and systems
• Manage and support key validated applications across various business units, including Clinical Development, Clinical Operations, Biostats, Regulatory, Drug Safety, and Pharmacovigilance
• Develop, implement, and maintain policies, procedures, and training plans for validated applications and systems
• Manage relationships with third-party vendors to ensure compliance and quality standards
• Create and maintain documentation for application configurations, services, processes, security, and compliance
• Provide technical support and troubleshooting for validated applications and systems
• Work with System Owners to prioritize and complete change control requests
• Assist in planning and managing the IT budget for technology projects and ongoing licenses
• Partner with the Computer Systems Validation team to ensure regulatory compliance and adherence to industry best practices
• Foster collaborative partnerships with business units to understand and support their IT needs
• Maintain accurate system documentation, including user requirements, design specifications, test plans, and summary reports
• Ensure day-to-day operational excellence, including administration, issue resolution, training, and change request handling
• Translate business needs into IT requirements and solutions

Qualifications

• 7+ years of experience in Validated Applications Management in Biotech or pharmaceutical companies
• BS/BA in Information Technology or related field required
• Demonstrated success in implementing validated applications, managing project budgets, plans, and requirements, and identifying potential gaps (Experience with Veeva Vault, SAS, and similar IT systems is a plus)
• Experienced in consulting with key business stakeholders to strategically translate customer needs into executable action plans
• Proficient in project management skills with capability to manage multiple projects simultaneously and adapt to changing priorities
• Strong attention to detail, coupled with creative thinking, to work through obstacles
• Excellent interpersonal, communication, and presentation skills with the ability to interface seamlessly with other parts of the organization
• Team player that is willing to go the extra mile to help the organization achieve its goals
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• The salary range for this position is commensurate with experience

Education

• BS/BA in Information Technology or related field