Quality Analyst

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🔥 14 hours ago

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Inizio

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

Inizio is a comprehensive commercialization partner that offers tailored solutions to health and life sciences companies. With expertise spanning clinical development, product launch, and data-driven insights powered by technology and AI, Inizio navigates the complexities of the drug lifecycle to maximize patient access and enhance treatment outcomes. They cater to a diverse range of therapeutic areas, including oncology, and are equipped to support companies from early-stage development through to commercialization, ensuring value is unlocked at every opportunity.

📋 Description

• Conduct interaction monitoring and review of documentation to ensure adherence to regulatory requirements and specific client guidelines. • Identify quality and performance issues and partner with Program Leadership to provide coaching, feedback, and training that improves quality standards. • Assist with implementation and enforcement of Quality and Compliance initiatives and activities as assigned. • Participate in internal and external client audits as directed by Program Leadership. • Score and document the results of each interaction monitored in the project quality management system to ensure timely feedback to the Inizio Engage staff. • Coordinate and participate in internal and client calibration sessions with Program Leadership and participate in discussions to promote scoring consistency, quality standards, and continuous improvement. • Support continuous quality improvement initiatives by identifying trends, recommending corrective actions, and contributing to process and documentation improvements. • Compile, analyze, and report Quality Assurance (QA) metrics, identify trends, and recommend updates to procedures, training materials, and quality documentation where appropriate. • Collaborate with Program Leadership to ensure all resource materials are updated, versioned, and meet requirements needed for future audits as directed. • Review signature compliance for evaluation forms within the Quality Monitoring System and programme/program updates within the Inizio Project Update System to ensure timely completion in accordance with Inizio policies. • Assist Program Leadership in preparing and certifying program staff, as requested.

🎯 Requirements

• Current registration and good standing with the Professional Regulation Commission (PRC) and the applicable Philippine healthcare professional regulatory board (e.g., Board of Nursing or Board of Pharmacy) is preferred. • Bachelor's degree from an accredited college or university, or an equivalent combination of education and relevant work experience preferred. • Knowledge of United States healthcare systems, medicines regulation, and pharmacovigilance requirements preferred. • Experience in Medical Information, Pharmacovigilance, Patient Support Programs, healthcare call centers, or related pharmaceutical industry roles preferred. • Internal auditing and call monitoring experience is strongly preferred. • Training and coaching experience is preferred. • Demonstrated proficiency in spoken and written English, with the ability to communicate professionally with U.S.-based healthcare professionals, patients, caregivers, and consumers. • Proficiency in Microsoft Office applications (Outlook, Word, Excel, PowerPoint, and Teams), business applications, and contact center technologies. • Ability and willingness to work schedules that support U.S. business operations, including evenings, overnight shifts, weekends, and holidays, as required. • Strong analytical, critical thinking, problem-solving, and organizational skills. • Ability to manage multiple priorities and adapt in a fast-paced environment. • Demonstrated initiative, self-discipline, attention to detail, and effective time management in a remote work environment.

🏖️ Benefits

• Must safeguard confidential information by complying with client confidentiality requirements, HIPAA Privacy and Security Rules where applicable, the Philippine Data Privacy Act of 2012 (Republic Act No. 10173), company information security requirements, and applicable regulatory requirements.