Lead the planning, execution, and governance of Medical Affairs IT programs, ensuring alignment with strategic business goals and global standards.
Oversee the full lifecycle of initiatives—from requirements gathering and solution design to delivery, support, and enhancement.
Conduct in-depth analysis of business needs and translate them into functional and technical requirements.
Collaborate with stakeholders to define user stories, process flows, and system specifications that drive value.
Partner with Medical Affairs, Pharmacovigilance, Product Quality Compliance, CRM, and Organon Service Centre teams to ensure seamless integration and optimization of systems.
Facilitate alignment between IT capabilities and the organization’s roadmap through effective stakeholder engagement.
Apply expertise in change management, service management, SDLC, and incident management to maintain high standards of performance and reliability.
Monitor and improve service delivery metrics, ensuring responsiveness and quality in support operations.
Manage relationships with external vendors and development partners to ensure timely delivery of scalable, compliant solutions.
Oversee vendor performance and ensure adherence to contractual obligations and service-level agreements.
Implement and uphold best practices in Computer Systems Validation (CSV), Data Integrity, and regulatory compliance across all Medical Affairs platforms.
Ensure that IT solutions meet internal audit standards and external regulatory requirements.
Identify opportunities for innovation and process enhancement within Medical Affairs systems.
Lead initiatives that improve system usability, performance, and business impact.
Act as a trusted advisor to business clients, providing strategic guidance and responsive support.
Communicate effectively across technical and non-technical audiences to foster collaboration and transparency.
Meet all compliance obligations through tasks such as requirements elicitation and documentation, User Acceptance Test planning and coordination, requirements traceability, and software development lifecycle (SDLC) best practices.
Work directly and collaboratively with business and technology stakeholders across disciplines and at all levels to implement new solutions and updates to our current Medical Affairs systems.
Requirements
Bachelor’s degree or equivalent in Engineering, Sciences, Information Systems, or related field preferred.
At least five years of relevant experience in Solution Architecture, Program management, working with business teams, building and delivering effective business processes aligned to Medical Affairs solutions
Providing IT support for Medical Affairs and coordinating with development partners, Pharmacovigilance, Product Quality Compliance, CRM and Organon Service Center (OSC), AI, Automation and MuleSoft teams on future enhancements
Demonstrated ability to lead complex, cross-functional initiatives that align IT capabilities with business objectives, delivering measurable outcomes.
Adept at navigating dynamic, fast-paced environments with competing priorities; excels in managing multiple programs and stakeholders simultaneously.
Skilled in translating business needs into actionable deliverables—user stories, use cases, process flows, wireframes, and data mapping while facilitating trade-off discussions and stakeholder alignment.
Quick to learn and apply emerging technologies to solve business challenges; brings a balance of technical depth and business acumen
Strong problem-solving skills with the ability to think both analytically and innovatively to drive continuous improvement.
Strong interpersonal and communication skills with a proven ability to influence, facilitate, and build consensus across diverse teams.
Experience in authoring and reviewing documentation aligned with IT Software Development Life Cycle (SDLC) standards and regulatory expectations.
Strong commitment to tangible and valuable outcomes.
Experience in creating and reviewing IT Software Development LifeCycle (SDLC) documentation.
Three to four years of Project management experience using MS Project, Smartsheet and Jira.
Benefits
retirement savings plan
paid vacation and holiday time
paid caregiver/parental and medical leave
health benefits including medical, prescription drug, dental, and vision coverage
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