Jobs at Alkermes

Supports R&D IT systems for development, clinical, regulatory, medical, and pharmacovigilance teams in a GxP-regulated pharmaceutical environment. Responsibilities include requirements elicitation, system lifecycle documentation, vendor management, data migration, integrations, issue resolution, solution improvement, and cross-functional delivery. The role ensures FDA computer systems validation, cybersecurity, regulatory, and SOP compliance while supporting Veeva and other R&D platforms.

Leads global pharmacovigilance quality oversight, including risk-based audits, REMS compliance, vendor management, inspection readiness, CAPA remediation, quality systems governance, and continuous improvement. Partners with Drug Safety, Regulatory Affairs, Medical Affairs, Clinical Development, IT, Legal, and external providers to ensure compliance with GVP, FDA regulations, ICH guidance, and organizational quality standards across clinical development and post-marketing activities.

Leads enterprise platform engineering and AI enablement by building secure, scalable AWS platforms, internal developer services, automation, CI/CD standards, infrastructure-as-code practices, monitoring, reliability controls, and governance. Partners with architecture, security, infrastructure, data, and delivery teams to operationalize AI, machine learning, analytics, and generative AI workloads. Advises senior leadership, drives technical initiatives, improves developer productivity, mentors engineers, and supports regulated-industry compliance.

Leads the planning, execution, and delivery of Phase 1 clinical studies in healthy volunteers. Oversees study budgets, timelines, resources, CROs, vendors, compliance, eTMF quality, inspection readiness, risk mitigation, and operational performance. Partners with cross-functional clinical development teams, supports regulatory submissions and inspections, and drives process improvements. Mentors Clinical Operations staff and promotes quality, accountability, and on-time study delivery.

Oversee contract manufacturing quality activities, including batch records, deviations, investigations, change controls, and product release. Maintain quality systems and ensure compliance with FDA and EU cGMP requirements. Lead quality investigations, monitor trends and risks, support product development across API, drug product, and labeling operations, review regulatory submissions, and provide QA guidance and mentoring to associates and cross-functional teams.

Leads new product planning for pharmaceutical pipeline products by developing market strategies, positioning, product profiles, forecasts, and commercial assessments. Co-leads cross-functional product teams through clinical development, synthesizes market and competitive insights, and prioritizes indications across therapeutic areas. The role requires strong pharmaceutical commercialization, market research, analytical, influencing, and facilitation skills, with occasional travel and a hybrid Waltham, Massachusetts work arrangement.

Leads PMO governance and program management for commercial infrastructure initiatives. Establishes project plans, RAID logs, dependencies, milestones, budgets, dashboards, and executive reporting. Coordinates cross-functional stakeholders across IT, data, commercial operations, finance, and procurement. Supports marketing technology initiatives, acquisitions, organizational transformation, integration planning, roadmap development, and standardized PMO processes.

Manages the pharmaceutical Medical/Legal/Regulatory review process for assigned brands, coordinating submissions, stakeholders, committee meetings, approval queues, final regulatory approvals, records, reports, and audits. Ensures SOP adherence, educates internal and external partners on Veeva Vault processes, supports system improvements and training documentation, tracks metrics, and provides project management support.

Sells Alkermes psychiatric products throughout the East Texas territory, educates healthcare providers, manages target accounts, develops business plans, uses promotional resources, controls expenses, and maintains promotional and sample compliance. Requires pharmaceutical or biotech sales experience, strong territory management, analytical and communication skills, a valid driver’s license, and residence within the assigned geography. Some overnight travel may be required.

Sell Alkermes psychiatric and CNS pharmaceutical products across the Austin territory. Build healthcare-provider relationships, educate providers, manage target lists, execute territory business plans, use approved promotional resources, maintain compliance, control expenses, and collaborate with sales, marketing, medical, and headquarters teams. The role requires at least three years of pharmaceutical or biotech sales experience, a bachelor’s degree, a valid driver’s license, and residence within the territory.

Leads enterprise core infrastructure and cloud operations strategy, modernization, reliability, security, and lifecycle management across five global facilities. Oversees compute, virtualization, operating systems, networking, storage, backup, monitoring, patching, resilience, disaster recovery, vendors, budgets, and managed service partners. Manages four direct reports and approximately 50 partner resources while aligning infrastructure roadmaps with business, security, compliance, and operational priorities.

Sells Alkermes psychiatric products within the Fort Lauderdale territory, educates healthcare providers, manages target accounts, develops territory business plans, uses promotional resources, controls expenses, collaborates with internal teams, and maintains compliance with promotional and sample-accountability policies.

Leads global Marketing and Sales procurement strategy, category management, strategic sourcing, supplier relationships, negotiations, contract management, and value realization. Partners with senior commercial, Finance, Legal, and Compliance stakeholders; manages sourcing events, supplier governance, budgets, reporting, risk mitigation, and continuous improvement. Leads cross-functional initiatives, mentors procurement staff, and supports procurement transformation in a global pharmaceutical organization.

Prepare general ledger journal entries, support month-end close, reconcile accounts and intercompany balances, analyze expenses, process accruals, fulfill external audit requests, and maintain compliance with GAAP, Sarbanes-Oxley, and SEC requirements. The role also supports FP&A, handles accounting special projects, and requires collaboration across internal and external stakeholders in a hybrid office environment.

Leads financial reporting, tax compliance, governance, audit management, internal controls, and statutory reporting for Irish legal entities. Presents financial results to global leadership, ensures US GAAP and IFRS compliance, manages audits and control frameworks, and drives finance transformation, automation, and system improvements. Provides leadership to the Finance team and advises senior stakeholders across Finance, Tax, Legal, Operations, and corporate functions.

Lead late-stage small-molecule drug product process development, scale-up and technical transfer (Phase 3 to PPQ). Provide technical oversight at internal and external manufacturing sites, design experiments, develop control strategies, author regulatory process sections, present data to senior management, mentor junior staff, and identify new process technologies.

Lead global regulatory strategy for clinical-stage programs, author and coordinate IND/CTA submissions, advise cross-functional teams, manage submission timelines and risks, respond to regulatory authority questions, and monitor regulatory policy and competitive landscape to support product development and registration.

Provide high-level administrative support to the VP of Commercial Operations and leadership team: manage complex calendars, travel, expense reports, contract routing, meeting logistics, onboarding coordination, records and document management, and lead departmental projects and events in a hybrid (60% on-site) environment.

Sells Alkermes psychiatric and neurological products within the Gainesville territory. Responsibilities include educating healthcare providers, managing target lists and call frequency, executing approved promotional programs, developing business plans, controlling expenses, maintaining compliance, and collaborating with sales, marketing, medical, and headquarters teams.

Sells Alkermes pharmaceutical products throughout the South Dakota territory, educates healthcare providers, manages target accounts, and supports promotional programs. Responsibilities include territory planning, provider engagement, business planning, expense control, administrative reporting, cross-functional collaboration, and compliance with promotional and sample-accountability policies. Candidates must have a bachelor's degree, at least two years of successful pharmaceutical or biotech sales experience, reside in the territory, maintain a valid driver's license, and meet provider credentialing requirements.