
Patient Oriented Programs Manager
5 days ago
Job Title: Patient Oriented Programs Manager
">Role SummaryThe primary responsibility of this role is to manage patient-oriented programs, ensuring compliance in end-to-end activities as per applicable processes and quality standards.
Liaison with cross-functional teams for successful program execution is a key aspect of this role.
Key Responsibilities:- Administer end-to-end patient oriented process on behalf of Business Owner in accordance with Doing Business Ethically policy and POP Standard Operating Procedures.
- Coordinate with all patient-oriented stakeholders, including Procurement, Legal, Patient Safety, Compliance, Quality Assurance, and create program documents.
- Responsible for obtaining necessary approvals for program conduct in a timely manner.
- Manage External Service Providers compliance check prior to fieldwork initiation.
- Enter program details in the POPsys database throughout program conduct.
- Keep track of all required activities, including First Participant First Contact, Last Participant Last Contact dates, Adverse Event Reconciliation, Periodic Reviews, closure, etc.
Maintain documentation for all patient-oriented related activities in the POP repository.
Ensure identified quality issues are well documented in quality issue management tool.
Create issue records and perform proper investigation, root cause analysis followed by risk assessment and corrective actions.
Ensure proper handover of activities when leaving the role or organization planned leaves and liaise with patient-oriented champion.
Effective management of assigned projects and timely escalation of findings related to projects.
Seek constant feedback from stakeholders and improve on suggestions put forth.
Requirements:- Preferrable experience with 2-5 years in the pharmaceutical industry within Clinical Pharmacovigilance, Medical Regulatory Affairs, or relevant experience in pharma compliance or commercial framework.
- Good understanding of local regulatory requirements and applicable policies surrounding pharmaceutical industry.
- Ability to communicate effectively across different audiences, organizational levels, and local and global teams.
College university degree preferably in security, criminal justice, crisis management, business continuity, or other related field. Advanced degree is highly desirable, e.g., Masters degree or MBA.
We believe our purpose is to reimagine medicine to improve and extend people's lives.
Our vision is to become the most valued and trusted medicines company in the world.
We seek curious and analytical individuals who can drive us towards achieving our ambitions.
What We Offer:- Competitive compensation and benefits package.
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.
- Chance to be part of a mission-driven organization.
If you're passionate about improving healthcare outcomes and want to join a team that shares your values, we encourage you to apply.
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