Jobs at Shionogi Europe

The Neurology Account Specialist drives sales for RADICAVA in an assigned territory, develops and executes territory business plans, engages neurologists and ALS healthcare stakeholders, and supports product access and formulary positioning. The role requires analyzing sales and market data, building relationships with key opinion leaders, collaborating across medical and commercial teams, maintaining clinical and product expertise, ensuring regulatory compliance, and traveling up to 30% with frequent overnight stays.

Drives sales of RADICAVA in an assigned territory by executing business plans, engaging neurologists and ALS centers, analyzing sales and market data, navigating formularies, and building relationships with healthcare professionals and key opinion leaders. Provides scientifically informed product discussions, collaborates with medical and access teams, supports product initiatives, and ensures compliance with pharmaceutical regulations. The role requires frequent overnight travel of up to 30%.

The Neurology Account Specialist will drive sales objectives for an assigned territory by developing business plans, engaging healthcare professionals, and building relationships with neurologists, ALS centers, hospitals, and key opinion leaders. Responsibilities include presenting clinical and product information, analyzing sales and market data, navigating formularies, supporting product positioning, collaborating with internal teams, maintaining regulatory compliance, and executing company initiatives. The role requires travel of up to 30%, including frequent overnight stays.

Supports CMC regulatory strategy, documentation, submissions, agency interactions, risk mitigation, and cross-functional coordination for pharmaceutical product development. The role ensures compliance with global FDA, EMA, and ICH requirements, maintains regulatory records, assesses evolving regulations, and supports regulatory meetings and strategic decisions. It requires at least five years of pharmaceutical CMC regulatory affairs experience, strong analytical and communication skills, and the ability to work in a hybrid environment with travel.

Drive sales objectives for RADICAVA in an assigned territory by developing business plans, engaging neurologists and ALS centers, analyzing territory and sales data, navigating hospital formularies, and building relationships with key opinion leaders. Provide scientifically relevant product discussions, collaborate with internal teams, execute company initiatives, maintain clinical and product expertise, and ensure compliance with pharmaceutical regulations. Travel may include frequent overnight stays.

Leads enterprise IT operations spanning infrastructure, cloud, networks, servers, storage, workplace technology, service desk, and managed service providers. Establishes technology roadmaps, governance, service management, architecture, security, compliance, disaster recovery, vendor performance, and operational budgets. Oversees managers and technical teams, directs major incident resolution, supports regulated pharmaceutical operations, and ensures infrastructure practices meet GxP, CSA, CSV, and 21 CFR Part 11 requirements.

Serves as the CEO’s operational partner, managing executive governance, leadership meetings, Japan headquarters alignment, reporting cycles, strategic planning, and cross-functional initiatives. Tracks priorities, risks, milestones, and accountability while maintaining digital collaboration platforms, dashboards, and knowledge systems. Partners with Finance, Commercial, Medical, Regulatory, and HR, and prepares executive communications, presentations, and briefing materials. Requires extensive pharmaceutical industry experience, commercial expertise, strong project management, executive presence, and ideally Japanese language and cross-cultural experience.

Leads global and U.S. regulatory strategies for pharmaceutical development programs and marketed products. Oversees regulatory submissions, lifecycle management, health-authority interactions, regulatory risk assessment, and cross-functional decision-making. Develops evidence packages, submission narratives, negotiation positions, and mitigation strategies while ensuring compliance with global requirements. Provides guidance and mentorship to regulatory professionals and manages regulatory deliverables across complex programs.

The Neurology Account Specialist drives pharmaceutical sales for RADICAVA in an assigned territory. Responsibilities include developing territory business plans, meeting sales objectives, engaging neurologists and ALS center personnel, analyzing market and sales data, supporting formulary access, managing key relationships, executing launches, and collaborating with medical, access, and regional teams. The role requires compliance with pharmaceutical regulations and up to 30% travel, including frequent overnight stays.

Coordinates pharmaceutical supply chain activities, including shipments, 3PL communications, contracts, licensing renewals, serialization, procurement, inventory reporting, invoice reconciliation, and supplier issue resolution. Supports process improvements and global supply chain meetings while ensuring compliance with GDP, GMP, company policies, and regulatory requirements.

The Key Account Manager will drive hospital formulary adoption, access, and sales for anti-infective products across an assigned territory. Responsibilities include educating infectious disease physicians, pharmacists, microbiologists, and formulary decision-makers; developing account and territory plans; coordinating educational programs; navigating reimbursement and P&T processes; collaborating with medical, marketing, and market access teams; and meeting field productivity goals. The role requires approximately 80% travel, extensive hospital pharmaceutical experience, and strong clinical, communication, and relationship-building skills.

Leads regional pharmaceutical sales for approved neurology products, including hiring, coaching, and managing Neurology Account Specialists. Develops and executes regional sales strategies, manages budgets, analyzes sales performance, supports product launches, builds relationships with key opinion leaders and healthcare stakeholders, and ensures regulatory and corporate compliance. The role requires strong pharmaceutical market knowledge, sales leadership, business acumen, and frequent travel.

Manages program execution for Shionogi’s U.S. government-funded pharmaceutical agreements with agencies including BARDA, NIH, and DOD. Coordinates cross-functional teams, budgets, compliance reporting, risk mitigation, government communications, and program deliverables. Supports contract reporting, financial reconciliation, proposal development, audit readiness, and collaboration across R&D, Finance, Regulatory Affairs, and Legal. Requires at least five years of relevant pharmaceutical, biotech, government operations, or contract management experience and up to 10% travel.

Provides GCP quality oversight for clinical studies, CROs, and vendors. Conducts and manages audits, evaluates clinical documentation and processes, supports regulatory inspections, identifies compliance risks, and oversees CAPA remediation. Advises cross-functional clinical teams on ICH GCP, FDA, EMA, PMDA, and company requirements while protecting data integrity, product quality, study compliance, and patient safety. The role requires up to 25% domestic and international travel and at least 50% monthly office presence in Florham Park, New Jersey.

Leads Shionogi’s commercial data ecosystem, including cloud data warehouse architecture, syndicated and payer data integration, master data management, governance, compliance, analytics enablement, CRM data flows, and vendor oversight. Owns semantic definitions, data quality, acquisition strategy, AI-ready data access, budgets, and operational roadmaps. Develops the commercial data management team and partners across Commercial, Market Access, Medical, Finance, IT, Analytics, Legal, and Compliance. Requires extensive pharmaceutical commercial data experience and 10–20% travel.

Leads a regional pharmaceutical sales organization focused on neurology products. Responsibilities include hiring, coaching, and managing Neurology Account Specialists; developing regional sales strategies; launching products; managing budgets; analyzing sales data; building relationships with physicians and key opinion leaders; ensuring regulatory compliance; and driving regional business growth.

Leads a regional team of Neurology Account Specialists, oversees pharmaceutical product launches, develops and executes sales strategies, manages budgets, hires and coaches sales staff, builds relationships with key opinion leaders, analyzes sales data, ensures regulatory compliance, and drives regional business growth. Requires significant pharmaceutical sales and sales management experience, preferably in neurology, rare disease, CNS, orphan drugs, or new product launches.

Leads global, cross-functional rare disease clinical development programs from early development through registration and lifecycle management. Drives integrated strategy, governance, portfolio prioritization, risk mitigation, resource planning, and execution across clinical, regulatory, CMC, and commercial functions. Synthesizes complex data for senior leadership, coordinates global stakeholders and external partners, supports lifecycle expansion and real-world evidence integration, and mentors program leadership talent.

Establishes hospital formulary access and demand for anti-infective pharmaceutical products across an assigned territory. Educates infectious disease physicians, pharmacists, microbiologists, and other stakeholders; navigates formulary and reimbursement processes; develops account and territory plans; builds institutional relationships; delivers educational programs; collaborates with medical, market access, marketing, and regional teams; and achieves adoption and sales goals while maintaining regulatory compliance.

Leads commercial IT strategy, roadmap planning, systems architecture, integrations, data governance, compliance, vendor delivery, budgets, and technical teams supporting pharmaceutical Sales, Marketing, and Market Access functions. Oversees commercial applications throughout their lifecycle, ensures data integrity and privacy compliance, manages incidents and business continuity, and partners with global, quality, privacy, and commercial stakeholders.