Medical Affairs Operations Specialist/Manager

Medical Affairs Strategic Operations Specialist / ManagerLocation: Titusville, NJ (Hybrid: 3 days onsite / 2 remote)Duration: 12 month contract with potential for extensionTravel: Up to 10%OverviewAs a key member of the Strategic Operations Team, the Medical Affairs Strategic Operations Specialist/Manager supports the execution of operational initiatives across Real World Evidence (RWE), Franchise teams, and Therapeutic Area functions. This role is critical to ensuring efficient delivery of medical programs through strong project management, vendor oversight, and cross-functional coordination.Key ResponsibilitiesOperational ExcellenceCoordinate across cross-functional teams to ensure seamless execution of medical affairs programsTrack and deliver against key performance indicators to drive efficiency and effectivenessIdentify risks proactively and implement solutions to maintain operational continuityProject Management & Systems ExecutionLead project intake, setup, and tracking within internal systems (e.g., WESS)Manage timelines, budgets, and resource allocation across multiple initiativesSupport both evidence-generation and non-evidence-generation projectsFinancial & Contract ManagementOversee end-to-end purchase order (PO) lifecycle, including creation, tracking, and reconciliationManage contract requests, invoice approvals, and overall spend trackingEnsure compliance with internal financial processes and systems (e.g., Ariba/eMP)Vendor ManagementBuild and maintain relationships with external vendorsMonitor Statement of Work (SOW) execution and vendor performanceTrack deliverables, budgets, and KPIs to ensure successful outcomesEvidence Generation SupportSupport operational execution of Real World Value & Evidence (RWVE), Investigator-Initiated Studies (IIS), and collaborative studiesFacilitate study intake through final deliverables, including submissions (e.g., Totality, ReCAP)Partner with cross-functional teams to ensure timely and high-quality study executionMedical Education (CME) CoordinationManage CME request intake process, including portal monitoring and notificationsMaintain CME tracking tools and ensure documentation is stored appropriately (e.g., SharePoint)Ensure compliance and timely processing of all requestsClinical & Study Operations SupportAssist in tracking and managing ongoing clinical studiesCoordinate protocol intake, approvals, and review meetingsSupport transition and setup activities across multiple studiesProcess ImprovementIdentify and implement enhancements to workflows and operational processesContribute to continuous improvement initiatives to optimize delivery and scalabilityQualificationsEducation & ExperienceBachelor’s degree required; advanced degree (e.g., MBA) preferredSpecialist: 2–4 years of relevant experienceManager: 3–5+ years of relevant experiencePrior experience in pharmaceutical, biotech, or related industry strongly preferredCore CompetenciesStrong project management and organizational skillsDemonstrated ability to collaborate across cross-functional teamsAbility to translate insights and data into actionable executionSelf-starter with strong ownership mindset and ability to manage multiple prioritiesTechnical SkillsHigh proficiency in Microsoft Office (Excel, PowerPoint)Experience with SharePoint and Microsoft Teams requiredFamiliarity with financial systems (e.g., Ariba/eMP) preferredAbility to quickly learn internal systems (e.g., WESS)Preferred ExperienceBackground in Clinical Operations (ClinOps) or Medical Affairs operationsExperience with CME coordination and/or IIS processesExposure to budget tracking and financial planningCertifications such as PMP, Six Sigma (Green Belt), or change management (e.g., Prosci) are a plusSoft SkillsStrong communication (written and verbal) and stakeholder management skillsComfortable working in a fast-paced, evolving environmentProactive problem-solver with critical thinking capabilitiesAbility to operate independently with minimal supervision after onboarding