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ICON plc

Integration Procedural Documentation Manager

Reposted 21 Days Ago
Be an Early Applicant
Remote
Hiring Remotely in United States of America
Mid level
Remote
Hiring Remotely in United States of America
Mid level
The manager will oversee operational planning, implement process improvements, manage KPIs, and coach team members to enhance efficiency.
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Integration Procedural Documentation Manager

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

Working with SOP Acquisition Lead to assist in the coordination of the assessment and transition plan for possible integration of procedural documentation into the SOP model for clinical, medical, safety, regulatory, and quality management system processes relating to business deals.

What You Will Do:

  • Developing SOP mapping between SOPs and the aquiree’s sponsor/contract research organization (CRO)/vendor procedural documentation

  • Conduct comparison assessments between the procedural documentation to identify major gaps and work with the business process owner and SOP authors to validate

  • Facilitate the risk assessment of gaps with the business and document any interim procedures to mitigate the risk

  • Develop the official transition communication (using templates)

  • Develop the retirement strategy

Your Profile:

  • BS/BA Degree plus 5+ years Pharma experience.

  • Demonstrated experience in project management and implementation techniques.

  • GxP experience and a strong working knowledge and understanding of drug development processes.

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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