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Job Description

Manager, Lab Quality

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Durham, North Carolina Full time R1393650

Durham, North Carolina| North Carolina

Job description

We are seeking a Manager, Lab Qualityto join Q2 Solutions, IQVIA’s laboratory business in Durham, NC.

We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development.

As a Manager, Lab Quality, you will be managing a group of medical writers, liaising with other managers, and supporting Global Medical Writing goals and initiatives. You will be performing senior review of all types of medical writing deliverables, acting as Lead Medical Writer on any type of writing project, and

keeping abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practices (GCP), along with developments and advances in drug development/medical and/or technical writing.

What you’ll be doing:

  • Managing performance of direct reports.
  • Proposing, reviewing, and approving budgets and assumptions for a range of project types within remit.
  • Having initial contact with customers on new projects, before a writer is assigned, or to support a direct report.
  • Initiating to tackle and advise others on new/unusual document types and customer requirements.
  • Participating in bid defense meetings and discussions.
  • Taking on a project management role for projects involving Medical Writing.
  • Preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, communicating directly with the customer, and monitoring and forecasting project budgets.
  • Planning and organizing workload for assigned projects and tasks: identifying project needs, tracking timelines and implementing customer requests.

What We Are Looking For:

  • Bachelor's Degree in life sciences related discipline or related field Required.
  • Master's Degree or Ph.D. in life sciences related discipline or related field Preferred.
  • Typically requires at least 7 years of highly relevant experience and related competency levels or equivalent combination of education, training, and experience.

The Knowledge, Skills and Abilities needed for this role:

  • Strong understanding of QC processes and technical writing.
  • Familiarity with ELN (Electronic Lab Notebook) and QMS (Quality Management System) preferred.
  • Understanding of entire lab workflow.
  • Experience with managing a team of direct reports.

What We Offer You:

We put our employees at the center of everything we do and are committed to providing them, and their families, with benefits that meet their diverse and changing needs.  We invest in integrated benefits programs and resources to take care of our employees’ physical, mental and emotional, financial and social well-being so they can thrive at home and at work, at any stage of their well-being journey.

To learn more about our benefits, visit https://jobs.iqvia.com/benefits.

If you’re looking to unleash your potential, join Q2 Solutions, IQVIA’s laboratory business, to help make the extraordinary possible!

Q² Solutions,IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

Q² Solutions’ ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding COVID-19 vaccination status.https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $95,100.00 - $142,700.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
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What gets me most excited about being part of
Q2 Solutions is working with cutting-edge technologies that help patients and further innovation in the field.