Category Manager - Expanded Access Programs (Hybrid)

Category Manager - Expanded Access Programs (Hybrid)Location: Waltham, MA (Preferred) or Upper Providence, PASchedule: Hybrid - Onsite 2 days per weekPay Rate: $80-$90/hourAlphanumeric is hiring a Category Manager to work in Waltham, MA with our client of over 20 years, a global biopharmaceutical company committed to improving lives through innovative medicines and scientific advancements.This role will provide operational leadership and oversight for oncology Expanded Access Programs (EAP) and Compassionate Use (CU) programs, ensuring patients have access to investigational therapies while maintaining compliance with regulatory requirements, company policies, and industry standards.ResponsibilitiesPartner with internal stakeholders to provide operational leadership for oncology Expanded Access and Compassionate Use programsDevelop and execute program strategies related to geographic footprint, drug supply, regulatory coordination, physician engagement, safety reporting, and overall program managementOversee the selection, onboarding, and management of vendors supporting access programsEstablish operational processes that ensure rapid and effective responses to physician requests regarding patient access to EAP/CU programsMonitor program utilization and provide regular status updates, metrics, and insights to key stakeholdersCollaborate cross-functionally with Global Medical Affairs, Clinical Operations, Supply Chain, Regulatory Affairs, Pharmacovigilance, Local Operating Companies (LOCs), physicians, and external partnersSupport program planning, implementation, and continuous improvement initiativesEnsure all program activities are conducted in compliance with applicable regulations, company policies, and Standard Operating Procedures (SOPs)Identify operational risks and implement mitigation strategies to ensure successful program execution.Build and maintain strong working relationships across internal and external stakeholder groupsQualificationsBachelor's degree in Life Sciences, Business, Healthcare Administration, Supply Chain, or a related fieldExperience supporting Expanded Access Programs (EAP), Compassionate Use Programs (CU), Medical Affairs, Clinical Operations, Patient Access, or related pharmaceutical programsStrong project management and operational leadership skillsExperience managing external vendors and service providersKnowledge of pharmaceutical regulatory requirements and compliance standardsExcellent communication, stakeholder management, and relationship-building skillsAbility to manage multiple priorities in a fast-paced, highly collaborative environmentStrong analytical, organizational, and problem-solving abilitiesPreferred QualificationsOncology experience within the pharmaceutical or biotechnology industryExperience working with global cross-functional teamsFamiliarity with safety reporting, drug supply management, and regulatory coordination processes