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Inizio

Guides clinical development and commercialization

Quality Analyst

Regulatory Compliance & EthicsUpdated on Nov 12
Full-timeManila, Metro Manila, PhilippinesNo salary listed

About the Job

Requirements

  • Current registration and good standing with the Professional Regulation Commission and applicable Philippine healthcare professional regulatory board is preferred.
  • A bachelor's degree from an accredited college or university, or an equivalent combination of education and relevant work experience, is preferred.
  • Knowledge of United States healthcare systems, medicines regulation, and pharmacovigilance requirements is preferred.
  • Experience in Medical Information, Pharmacovigilance, Patient Support Programs, healthcare call centers, or related pharmaceutical industry roles is preferred.
  • Internal auditing and call monitoring experience is strongly preferred.
  • Training and coaching experience is preferred.
  • Demonstrated proficiency in spoken and written English is required, including the ability to communicate professionally with U.S.-based healthcare professionals, patients, caregivers, and consumers.
  • Proficiency in Microsoft Office applications, including Outlook, Word, Excel, PowerPoint, and Teams, business applications, and contact center technologies is required.
  • Ability and willingness to work schedules supporting U.S. business operations, including evenings, overnight shifts, weekends, and holidays, as required.
  • Strong analytical, critical thinking, problem-solving, and organizational skills are required.
  • Ability to manage multiple priorities and adapt in a fast-paced environment is required.
  • Demonstrated initiative, self-discipline, attention to detail, and effective time management in a remote work environment are required.
  • Ability to lift, carry, and otherwise move up to 25 pounds is required.
  • Ability to sit, stand, or walk for various lengths of time throughout the day is required.
  • Ability to communicate effectively with clients and co-workers is required.
  • Ability to proficiently operate computer hardware and software daily, including computers, telephony systems, standard office equipment, and business applications, is required.
  • Ability to work remotely in a secure work environment and, where required, travel for business purposes is required.

Responsibilities

  • Monitor interactions and review 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 each monitored interaction in the project quality management system to ensure timely feedback to 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.
  • Maintain confidentiality while handling sensitive client, employee, and quality-related information.
  • Compile, analyze, and report Quality Assurance metrics; identify trends; and recommend updates to procedures, training materials, and quality documentation where appropriate.
  • Collaborate with Program Leadership to ensure resource materials are updated, versioned, and meet requirements for future audits as directed.
  • Review signature compliance for evaluation forms within the Quality Monitoring System and 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.
  • 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.

Desired Qualifications

  • Knowledge of United States healthcare systems, medicines regulation, and pharmacovigilance requirements.
  • Experience in Medical Information, Pharmacovigilance, Patient Support Programs, healthcare call centers, or related pharmaceutical industry roles.
  • Internal auditing and call monitoring experience.
  • Training and coaching experience.

About the Company

Inizio

Guides clinical development and commercialization

Inizio helps health and life sciences companies navigate clinical development and commercialization to maximize patient access. It uses a connected suite of capabilities and expert guidance to shepherd assets through their entire lifecycle with tailored strategies for regulatory, clinical, and market steps. It differentiates itself by offering end-to-end, lifecycle-driven support that coordinates multiple disciplines rather than a single service. Its goal is to bring products to patients faster and more effectively while unlocking value and improving treatment outcomes.

Company size
5,001-10,000
Company stage
Not listed
Total funding
Not listed
Headquarters
New York City, New York
Founded
Not listed

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