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Batch Record Specialist

ICON plcICON plc·Pharmaceutical Services

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Posted

42 days

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About the role

Home - Based - Mexico

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Compliance Specialist II to join our diverse and dynamic team. The Compliance Specialist II is responsible for ensuring quality compliance is maintained within the Interactive TechNlogies division during both the project development phase and the maintenance phase.

What You Will Be Doing:

  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Perform Quality Management Review (QMR) on active projects.
  • Extract and review study data from the SQL database to ensure accuracy according to system specifications and client requirements.
  • Communicate with department management and project managers regarding quality and/or compliance issues and trends.
  • Conduct accurate and timely secondary review of QMRs.
  • Act as subject matter expert for compliance staff in specialized tasks.

Your Profile:

  • Bachelor's degree in a related field (e.g., Life Sciences, Regulatory Affairs, or Compliance).
  • Relevant experience in compliance, quality management, or a related field within the Interactive TechNlogies division.
  • Proficiency in performing Quality Management Reviews (QMR) on active projects, ensuring adherence to established quality standards and procedures.
  • Strong communication skills to effectively convey quality and compliance issues and trends to department management and project managers.
  • Perform accurate and timely secondary reviews of QMRs, identifying discrepancies and recommending corrective actions.
  • Act as a subject matter expert for compliance staff, providing guidance and support in specialized compliance tasks.
  • Collaborate effectively with cross-functional teams and colleagues to ensure compliance goals are met.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements

  • A range of health insurance offerings to suit you and your family’s needs.

  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.

  • Life assurance

  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

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Aplyr's read

ICON plc is a leading global provider of outsourced services in the pharmaceutical industry, attracting professionals in clinical research and data management.

Synthesized from recent postings & public sources

What's promising

  • ICON plc has a strong global presence, enhancing its ability to manage international clinical trials effectively.
  • The company offers diverse career opportunities across various roles in clinical research and data analysis.
  • ICON's focus on innovation in pharmaceutical services supports its competitive edge in the industry.

What to watch

  • The pharmaceutical industry is highly regulated, which may limit flexibility in project execution.
  • ICON's reliance on large pharmaceutical clients could pose risks if partnerships dissolve.
  • The competitive nature of the CRO market may pressure ICON to maintain cost efficiency.

Why ICON plc

  • ICON plc specializes in comprehensive outsourcing solutions, differentiating it from competitors with narrower service scopes.
  • The company's integration of technology in clinical trials offers a unique advantage in data management.
  • ICON's strategic acquisitions have expanded its capabilities and market reach significantly.

Aplyr’s read is generated by AI from public sources. Was it useful?

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About ICON plc

ICON plc is a global provider of outsourced development and commercialisation services to the pharmaceutical, biotechnology, and medical device industries.

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