Business Monitoring & Competitive Advantage (BMCA) Specialist- Operational Audit Management
Position Purpose
The BMCA Specialist plays a critical role in driving operational excellence, monitoring program quality, and supporting strategic initiatives across Patient Support Programs (PSPs). This position oversees performance tracking, leads analytical reviews, and supports internal and external reporting. The Specialist also contributes to program innovation and business insights to enhance competitive advantage and access impact.
The ultimate purpose of this role is to shape and support sustainable access strategies globally by leveraging business intelligence, monitoring tools, and collaborative engagement to maximize medical benefits for patients.
Duties and Responsibilities
- Act as the primary focal point for assigned internal and external audits, managing the full audit lifecycle from notification to formal closure.
- Review and interpret audit scopes, regulatory requirements, and contractual obligations to define the audit response strategy.
- Validate audit responses, CAPAs, and supporting documentation to ensure accuracy, regulatory compliance, and alignment with Axios SOPPs.
- Lead coordination with internal stakeholders to address audit findings, clarify root causes, and define corrective and preventive actions.
- Perform trend analysis across audit findings to identify recurring risks, control weaknesses, or system-level gaps.
- Ensure timely closure of audit findings and provide status updates to the BMCA Lead and senior stakeholders.
- Support client and auditor communications, including clarification calls, follow-up questions, and final report reviews.
- Supervise the real-time tracking and monitoring of patient progress and logistics through Axios’ Patient Management System (PMS).
- Prepare and validate monthly, quarterly, and ad hoc reports for internal use and client submissions.
- Support quality assurance initiatives by conducting trend analyses and contributing to quarterly quality reports.
- Collaborate with department leads, program teams, and external stakeholders to ensure seamless service delivery and compliance with ethical standards.
- Oversee the reporting of adverse events and product complaints as per client protocols and Axios SOPPs.
- Contribute to the design, update, and implementation of SOPs and monitoring tools to support effective program governance.
- Attend and complete all required trainings provided by the pharmaceutical companies, including Pharmacovigilance and Product Training, with a clear understanding of how to collect and report safety data.
- Mentor junior team members within the BMCA unit and support their development.
- Represent the BMCA department in cross-functional initiatives and internal meetings.
- Monitor implementation of training completion across teams (e.g., Pharmacovigilance, product, and compliance training).
- Support risk mitigation and early warning mechanisms for non-compliance, deviations, or program gaps.
- Ensure that documentation, controls, and dashboards reflect international best practices and Axios policies.
- Participate in strategic discussions related to program optimization, access strategy, and stakeholder engagement.
- Support the implementation and monitoring of program efficiency initiatives, including tracking team performance indicators, identifying capacity gaps, and contributing to continuous improvement efforts across functions.
- Perform any other responsibilities assigned by the BMCA Lead or department leadership.
Relationships
- Supervise and work closely with the team.
- Work with project team leaders as well as the related divisions of Axios
- Maintain ongoing and frequent communication with project team leaders including Axios regional and global staff
Competencies
- Application of job Knowledge
- Concern for Order and Quality
- Adaptability and flexibility
- Dependability
Teamwork
Communication skills
Problem handling
Project management
Negotiation skills- Presentation skills
Educational Background and Experience
At least 2-5 years of professional experience in healthcare sector is ideal
Excellent command of both spoken and written English
Excellent communication skills
Excellent networking skills
Experience in data monitoring and management is an advantage
Experience coordinating and handling logistics/supply chain is a plus
Experience in communication service management
Job Circumstances
The position is based in our regional office and may require frequent travel to other locations, including offices outside your designated region, as needed
.
Flexibility in ability to travel as well as working hours is essential.