Dedicated and detail-oriented Lead Material Compliance Associate (MCA) with extensive knowledge of the MAC standards, and operational procedures. Adept at problem-solving with a patient-focused and compassionate approach, combined with strong communication and collaboration skills. Highly motivated and committed to excellence, with a proven ability to to support business needs through strategic decision making and process optimization. Demonstrates expertise in Veeva, liaising with sponsors to drive efficiencies and ensure high quality outcomes. Recognized for a strong work ethic, professional demeanor, and initiative in improving team performance and operational effectiveness.
Serve as the Lead MCA for one of the busiest MAC teams, ensuring seamless execution of urgent and critical deliverables for both patients and HCPs. Identify process gaps and recommended improvements within a complex matrix environment to enhance efficiency and compliance. Working closely and effectively with internal and external teams to maintain up-to-date processes, drive communication, and ensure accountability. Act as key liaison between cross-functional teams, demonstrating strong collaboration and communication skills to optimize patient and HCP support initiatives, label updates and internal materials (internal training and semester meetings). Lead Patient Support Program (PSP) MCA collaborating closely with BPO to maintain up-to-date processes. Partner with PSP BPO to uphold quality standards through PSP Quality Checks (PSP QCs) and provide ongoing training to MCA team members.
Communicated effectively with sponsors, management staff, delivering status updates on daily basis. Delegated and monitored progress of assignments, ensuring achievement of all deadlines. Responded quickly to sponsor and agency concerns and requests. Delivered exemplary customer service and support by remaining poised in most stressful situations. Escalated process issues to Team Manager, and product Material Compliance Manager for remediation assistance. Successfully led materials through Quality Check, which resulted in a positive outcome for weekly MAC meetings allowing reviewers to meet their target dates.
Prepared financial and regulatory reports required by laws, and regulations. Preparation for office deposit of cash for Dunbar, done several times a week. Manage receptionist area, including greeting visitors and responding to telephone and in-person requests for information. Trained junior team members on administrative processes, company requirements and performance strategies. Updated patient accounts and information on a daily basis. Managed and controlled office supply inventory to ensure timely ordering. Received incoming packages and mail, dispersed parcels and correspondence and shipped outgoing items daily. Performed debit, credit and total accounts on computer spreadsheets/databases, using specialized accounting software. Documented, reported, and followed up on discrepancies. Coordinated daily to weekly scheduling and rescheduling for several Physician's calendar's.
Completed and submitted clinical/interpretation documentation in accordance with agency guidelines. Prepared patient rooms prior to their arrival. Provided professional care in pre and post-operative situations. Provided necessary assistance to medical staff and patients for unit specific procedures. Assisting and Interpreting for patients with chronic illnesses. Escorted patients to examination rooms and prepared them for physician exams. Served as a liaison between patients and physicians (i.e., Orthopedic Surgeon, Pain Management Specialist, General Surgeon, Psychologist, Therapist, Physician Assistants) to assist and interpret for patients in understanding their treatment plans.