Otsuka Pharmaceutical Companies (U.S.)

Compliance

• Coordinate high-quality and on-time regulatory publishing deliverables aligned with assigned programs/products
• Identify impacts of agency guidance updates relevant to submission processes
• Drive innovative process changes to improve efficiency
• Provide regulatory publishing and submission assignments, monitoring, and oversight
• Lead or support GRA efforts
• Ensure assigned submissions are delivered with quality, on time, and within established budgets
• Act as primary liaison coordinating regulatory publishing activities for R&D functions
• Liaise with affiliates to coordinate and publish defined content
• Own delivery of electronic regulatory submissions and ensure compliance with health authority requirements and established schedules
• Design and implement processes and systems to maximize electronic lifecycle and maintenance submissions
• Ensure submission and archival activities
• Direct staff and contingent workers performing document quality-control checks and ensuring compliance with electronic regulatory standards
• Oversee project team members and work assignments to vendor partners
• Lead and guide Process Mapping Teams
• Develop and maintain regulatory operations work instructions
• Build collaborative relationships with colleagues
• Organize and maintain regulatory files
• Provide regulatory publishing guidance to other departments and functions

Manager, Regulatory Operations

Sales

• Report directly to the respective Area Business Lead
• Coordinate with Medical, Market Access, and Patient Support colleagues under appropriate guidelines
• Serve as the primary point of contact for healthcare provider customers
• Provide complex on-label information based on approved content
• Conduct proactive outreach to healthcare providers about product access, on-label information, and established patient care guidance
• Engage customers through virtual and digital tools and direct them to colleagues as needed
• Facilitate speaker programs
• Organize local provider groups to discuss experiences and outcomes with local or regional leaders
• Ensure customer requests are met and solicit feedback on engagement quality
• Collaborate compliantly with the ecosystem team to adjust targeting and call point plans
• Act on customer-facing insights to inform local strategy and business goals
• Elevate opportunities, feedback, and local market insights to the Area Business Lead
• Analyze territory and business conditions using competitive data, business reports, sales data, and promotional budget information
• Educate office staff on payer guidelines and reimbursement procedures
• Utilize promotional materials and internal support resources
• Overcome objections and influence prescribing habits during office calls
• Network with territory professional groups to identify potential key opinion leaders
• Build relationships with office and practice personnel
• Deliver balanced office calls and sales presentations using approved marketing materials and technical references

Pharmaceutical Sales, Neuroscience Specialist

Director

• Lead the management, organizational roadmap, optimization, and field adoption of sales systems, including CRM, Field Reporting, and other field technology tools
• Drive strategic enhancements, system performance, and cross-functional alignment to support commercial effectiveness
• Serve as a key partner to Field Strategic Operations, Brand, IT, Commercial Operations, and Analytics
• Act as business owner for sales systems supporting field teams across multiple therapeutic areas
• Develop Field Technology organizational roadmaps for supported sales divisions
• Drive system enhancements, configurations, and integration efforts with IT and external vendors
• Lead cross-functional initiatives that improve sales-force productivity through automation and process efficiencies
• Liaise between field sales and IT to ensure system performance and issue resolution
• Collaborate with Systems Training to create training materials, system guides, and end-user best practices
• Establish and monitor adoption metrics and identify improvement areas
• Partner with Commercial Analytics to provide meaningful insights and dashboards
• Work with IT to maintain data integrity, governance, and compliance within sales systems
• Assess system utilization data and provide strategic recommendations to leadership
• Collaborate across Field Strategic Operations, Brand, IT, and Marketing to align system capabilities with commercial priorities
• Manage external-vendor relationships and ensure system reliability and enhancements
• Contribute to vendor selection, contract negotiations, and service-level agreements

Manager, Regulatory Operations

Pharmaceutical Sales, Neuroscience Specialist

Associate Director, Field Technology