Manager of Post Market Compliance overseeing post - market surveillance for global medical device regulations. Engaging with cross - functional teams and maintaining compliance standards in a hybrid role.
About the role
- Clinical Compliance Specialist overseeing pharmacy compliance and inventory management while supporting regulatory compliance and quality assurance in a clinical setting.
Responsibilities
- Maintains and updates the central regulatory compliance database every week, ensuring accuracy of all state, federal, and institutional requirements.
- Collaborates with regional clinical leadership to manage controlled and non-controlled substance inventories in accordance with state and federal laws, department policies, and applicable regulatory bodies.
- Conducts monthly compliance audits and quality reviews, documents findings, and partners with leadership to implement corrective actions.
- Monitors daily tracking of controlled substance orders shipped by suppliers; verify shipments have been received and stocked.
- Generate tracking reports and monthly compliance summaries for CBS bases and clinical leadership.
- Interfaces with base clinicians regarding daily operations related to pharmaceutical supplies.
- Prepares various reports and maintains central database of required records and reports for CBS bases.
- Monitors and assists Clinical Base Leads and Clinical Directors with processes related to return-distribution of controlled substances and non-controlled medications.
- Return Distribution Systems - Responsible for managing site demographics and user access.
- Serves as a resource for Clinical Base Leads and Clinical Directors for assistance with reports and audits.
- Medication Management Systems – Responsible for managing employee access, item lists, monitoring reports, and resolving technical system issues.
- GS1 Hub & GLN Numbers – Assists with managing GS1 Hub generating GLN for new bases and archiving site data.
- Other duties as assigned
Requirements
- High School Grad or Equivalent and three (3) or more years related experience and/or training or equivalent combination of education and experience
- Associate’s degree (A.A.) or equivalent from two-year college or technical school and three to five years’ related experience and/or training; or equivalent combination of education and experience.
- Completion of an accredited pharmacy technician program.
- Minimum of three (3) years of pharmacy technician experience in a hospital or clinical pharmacy setting, with demonstrated knowledge of controlled substance regulations and inventory management.
- Five (5) years, preferred.
- Ability to effectively execute the Clinical Compliance department’s goals and objectives.
- Ability to be a team player with a professional attitude and exceptional customer service skills.
- Demonstrates critical thinking and reasoning skills, while working in a fast-paced environment that requires ability to prioritize and multi-task.
- Excellent organizational skills with exceptional attention to detail.
- Excellent written and verbal communication skills.
- A high level of self-motivation, initiative, flexibility, and ability to work independently and under pressure.
- Extensive knowledge of basic and advanced pharmacy practices and procedures.
- Proficient mathematical computation skills.
- Advanced with Microsoft Office Suite, including Word, Excel, PowerPoint, Teams, and Outlook.
- Knowledge of shared databases preferred.
- Must be prepared to learn a variety of systems applications for medication procurement and tracking.
- Certified Pharmacy Technician (CPhT) – Pharmacy Technician Certification Board (PTCB), required.
- Must maintain current state pharmacy technician license/registration where required by state law.
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