Jobs at AbbVie

Lead CMC regulatory strategy and manage regulatory submissions (INDs/CTAs, marketing applications, amendments) for biologics. Prepare agency meeting strategies, oversee change control and manufacturing requests, respond to regulatory information, and represent CMC in cross-functional teams to enable first-pass approvals.

Lead global regulatory strategy and product teams to secure and maintain market approvals across drug development and lifecycle. Develop regulatory dossiers, risk mitigation, labeling strategy, and alignment with senior management; interface with cross-functional stakeholders and regulatory agencies; mentor team members and drive regulatory policy and initiatives.

Designs and executes novel experiments, develops and optimizes methods, supports late-stage and commercial biologics manufacturing, technology transfer, process validation, scale-up, investigations and troubleshooting, mentors others, authors scientific/regulatory documents, and ensures GxP and safety compliance.

Develop and maintain relationships with thought leaders and HCPs in psychiatry to provide scientific support, present data, support research and advisory activities, train internal teams, and document activities. Ensure compliance with regulatory and company policies while managing territory expenses and supporting payer-facing initiatives as needed.

Lead clinical development programs for oncology (solid tumors), design and oversee clinical trials, interpret safety and efficacy data, and produce regulatory and clinical documents. Serve as clinical expert across cross-functional teams, engage external opinion leaders, and ensure compliance with GCP and regulatory requirements. May supervise other medical staff and chair Clinical Strategy Teams to align development plans with business goals.

Lead cross-functional CMC teams for small-molecule products from late development through commercialization. Manage project plans, budgets, regulatory submissions (IND/NDA/MAA), technical risk resolution, and stakeholder communication. Mentor CMC leads and promote best practices across S&T and operations.

Lead design, execution, interpretation, and oversight of hematology clinical development programs. Provide medical expertise for protocols, safety reporting, regulatory interactions, and cross-functional strategy. Manage clinical teams, investigator engagement, and ensure compliance with GCP and pharmacovigilance standards to support product development.

Lead planning and execution of one or more clinical studies, ensuring timelines, budgets, and quality (ICH/GCP) compliance. Manage cross-functional study teams, vendors, and external stakeholders; identify and mitigate risks; coach Study Management Associates; contribute to operational efficiencies and study design from initiation through completion.

Oversee design, execution, interpretation, and reporting of clinical trials for neuroscience/psychiatry programs. Provide medical/scientific leadership on protocol design, safety oversight, regulatory interactions, investigator engagement, and cross-functional development planning to support product strategy and compliance with GCP and pharmacovigilance standards.

Lead and coordinate district commercial activities for psychiatry products, drive sales through district planning and market insights, coach and develop field teams, collaborate with internal partners, ensure HCIR credentialing compliance, and monitor progress against targets to achieve business results.

Lead enterprise ServiceNow architecture and governance. Design scalable service management, portals, catalogs, HR, CSM, GRC, and workflow automation solutions. Partner with stakeholders, assess risks, mentor teams, and ensure compliance and alignment with enterprise standards and roadmaps.

Manage and author CMC sections for post-approval variations, develop content plans and timelines, coordinate cross-functional teams, ensure CTD/eCTD compliance, lead global programs, mentor junior staff, identify risks and template updates, and support renewals and annual reports.

Provide IP strategy and patent prosecution for AbbVie's pharmaceutical products. Draft, file, and prosecute patents worldwide; manage outside counsel; advise R&D and business teams; handle IPRs, oppositions, and due diligence; perform prior art searches and analyze third-party patent positions.

Leads clinical development programs, oversees study teams and compliance, analyzes data, and engages in external stakeholder interactions while ensuring regulatory adherence.

Design, configure, and tune DLP controls across email, print, web, removable media and data-at-rest. Analyze DLP events, implement preventative controls, create dashboards and reports, integrate continuous security event ingestion with Splunk, and perform insider risk data mapping and remediation across cloud and network storage.

Lead and coordinate in-field commercial teams to drive rheumatology sales within an assigned district. Create and monitor district sales plans, coach and develop direct and indirect reports, ensure compliance with HCIR credentialing, and partner with internal stakeholders on business planning and market strategies.

Serve as strategic HR partner for R&D business leaders, leading talent strategy, succession planning, org design, change management, manager development, and large-scale HR initiatives to support business objectives and employee engagement.

Lead HEOR strategy and execution for one or more assets/indications, design and oversee studies, translate findings for stakeholders, align HEOR plans with cross-functional product strategies, manage projects and small teams, and engage senior leaders and external partners to support commercial and pipeline objectives.

Provide legal strategy and counsel for AbbVie Oncology commercial activities. Advise cross-functional teams on product launches, promotion, compliance (FDA, Anti‑Kickback, FCPA, Sunshine Act), contracts, policy initiatives, and risk management. Develop policies, trainings, manage outside counsel, and translate regulatory changes into business guidance.

Support in vivo neuropsychiatric drug discovery using rodent behavior models: plan and run behavioral experiments, dosing and PK sampling, analyze and present data, comply with IACUC, assist surgeries and other in vivo work, and help design studies and compile reports.