
Patient Oriented Program Coordinator
6 days ago
We are seeking an experienced professional to manage the Patient-Oriented Program (POP) process, ensuring adherence to DBE policy and SOPs.
- The ideal candidate will administer the POP process on behalf of the Business Owner, coordinating with stakeholders including Procurement, Legal, Patient Safety, Compliance, and Quality Assurance.
- The selected individual will secure timely approvals for POP conduct, manage compliance checks with External Service Providers, and track program details in the POPsys database.
- This role involves maintaining comprehensive documentation in the POP repository, addressing quality issues using a quality issue management tool, and performing root cause analysis and CAPA as needed.
Key Responsibilities:
- End-to-End Management: Administer the POP process, ensure adherence to DBE policy and SOPs
- Stakeholder Coordination: Collaborate with stakeholders to create necessary POP documents
- Approval and Compliance: Secure timely approvals for POP conduct, manage compliance checks with External Service Providers
- Database Management: Enter and track program details in the POPsys database
- Documentation and Issue Management: Maintain comprehensive documentation, address quality issues, and perform root cause analysis and CAPA
- Handover and Project Management: Ensure effective handover of responsibilities, manage assigned projects efficiently
Required Skills and Qualifications:
- Experience: 2-5 years of experience in the pharmaceutical industry within Clinical, Pharmacovigilance (PV), Medical/Regulatory Affairs, or a related field
- Knowledge: Strong understanding of local regulatory requirements and pharmaceutical industry policies
- Communication: Effective communication skills across various audiences, organizational levels, and local and global teams
Benefits:
- Opportunity to work in the pharmaceutical industry
- Develop your expertise in patient-oriented programs
- Collaborate with diverse stakeholders
Others:
- A college/university degree is required, preferably in security, criminal justice, crisis management, business continuity, or a related field. Advanced degrees are highly desirable.
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