Amicus Therapeutics

Manager

• Work closely with patient/caregiver to support access to therapy
• Provide day-to-day oversight and coordination of caseload to ensure timely completion of activities and tasks
• Accurately document and maintain case history for all assigned patients
• Act as single point of contact performing preliminary benefits investigations, prior authorization and appeal support
• Communicate patient benefits and responsibility timely and accurately to patients and healthcare providers
• Complete a pre-screen to determine eligibility for financial support
• Troubleshoot complex cases while interfacing with internal and external stakeholders to ensure optimal start to therapy
• Professionally field incoming telephone calls and answer patient and medical office inquiries
• Provide ongoing adherence and compliance support for patients
• Provide back-up coverage for other Case Managers
• Attend patient and commercial strategy meetings where applicable
• Ensure compliance with legal and regulatory mandates and serve as a compliance role model

Case Manager

Compliance

• Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.
• The Quality Lead, Quality Compliance and Operational Excellence will oversee the Global Process for Product Complaints for Marketed Products and Clinical Trails and will also assist to drive organizational performance through workforce empowerment using collaboration, proven lean six-sigma tools, and change management methodologies.
• This role will emphasize compliance with SOPs and applicable regulations. They will interact with key stakeholders in the organization for timely and accurate receipt of complaint reports. This role will lead/facilitate complaint investigations, report complaint trends and escalate issues to Management. They will lead the training of Amicus personnel for the responsibilities and requirements for the identification and handling of complaints. This role will also interact with Health Authority inspectors as the Global Complaints Process Lead/SME.
• They will assist with supporting and developing a Quality Compliance and Continuous Improvement culture ensuring that Global Quality Operations are carried out in a compliant and efficient manner including leading and/or facilitating internal audits.
• They will compile and author Annual Product Quality Review (APQR) global summary reports for all commercial products.

Case Manager

Quality Lead – Compliance and Operational Excellence