Nobelpharma America, LLC

Account Manager

• Will be the primary contact with large comprehensive care centers/clinics providing medical care to individuals with TSC.
• Develop regional Plan of Action (POA) and participate in brand strategy implementation.
• Create and implement the KAM strategy to achieve monthly, quarterly and annual product access and launch objectives.
• Lead the development and execution of district- and region-level business plans aligning with national brand strategy.
• Develop, grow, and manage key account relationships with group physician practices.
• Conduct targeted business reviews with key accounts to optimize product utilization and expand market presence.
• Work closely with Medical Affairs and Marketing to develop relationships with Key Opinion Leaders.
• Maintain accurate and up-to-date account and provider data in CRM systems.

Key Account Manager

Compliance

• Serve as the accountable owner of the U.S. compliance framework, ensuring that compliance risks across regulatory domains are identified, documented, monitored, and appropriately mitigated.
• Maintain a consolidated, enterprise-level view of compliance status, risks, and mitigation progress across U.S. regulatory areas, including but not limited to Medical Information / OPDP, DSCSA, and state-level compliance.
• Act as a key advisor to the CEO and executive leadership by providing clear visibility into compliance risk exposure, trends, and inspection readiness.
• Prepare and present regular updates to executive management on material compliance matters, risk assessments, and remediation activities.
• Review and provide formal approval of compliance- and regulation-related documents to confirm they are complete, accurate, and aligned with applicable regulatory requirements and internal SOPs.
• Provide formal readiness confirmation for documents requiring executive signature, while ultimate legal responsibility remains with company officers.
• Coordinate with functional owners and external consultants to ensure accountability and timely remediation, without performing hands-on execution of operational tasks.
• Oversee adherence to Quality Assurance SOPs and quality processes outside of Pharmacovigilance, acting as the internal counterpart to external Quality Assurance consultants.
• Monitor compliance metrics, review audit findings and reports, and identify gaps or deviations from established quality standards.
• Require corrective actions where deficiencies are identified, confirm ownership and timelines with functional leaders, and escalate unresolved issues as necessary.
• Ensure that quality governance, documentation, and reporting practices are applied consistently across functions.
• Serve as the formal owner of the U.S. Pharmacovigilance Quality System, including governance of PV SOPs, deviations, CAPAs, training, and documentation readiness.
• Drive adherence to PV SOPs by internal teams and external vendors through oversight, guidance, and monitoring, while execution remains with responsible functions.
• Lead and coordinate FDA inspections, regulatory interactions, and internal audits related to Pharmacovigilance quality.
• Oversee PV vendors and adverse event and complaint case processing, including case quality, triage, and regulatory submission readiness.
• Review key safety deliverables (e.g., PADERs, DSURs) to confirm quality, completeness, and regulatory compliance.
• Maintain ongoing inspection readiness through periodic reviews of PV processes, records, training, and vendor performance.
• Oversee the design and effectiveness of U.S. quality and pharmacovigilance compliance training programs, including role-based training requirements.
• Promote a strong compliance culture by providing guidance and support to functional leaders and employees.
• Serve as a key escalation point for compliance questions, concerns, or potential issues.

Key Account Manager

Head of Quality and Pharmacovigilance Compliance