As a leading contract research organization (CRO), Labcorp Drug Development (formerly known as Covance) provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.
Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.
The "Manager, Global Regulatory Submissions" will collaborate with peers across the organization in order to achieve client-centric delivery in a matrix organization; in particular, collaboration across all stakeholders within Site Readiness. Essential Job Duties:
Requirements (Experience, Education, Qualifications and Skills)
- Oversight and accountability for RA/IRB/EC/Third Body submissions, including submission strategy,timeline planning, and delivering to the agreed upon timelines by tracking submission/approval timelines against projected milestones within relevant systems
- Provides consolidated country requirements and regular status updates to project team and Client, as applicable
- Responsible for ensuring the compliance of deliverables to applicable regulations, guidance requirements and client requests by preparing, reviewing and providing input to core study documents as applicable. This may include the compilation, review and distribution of core package, QC of core package, and country packages, maintenance and close out
- Provide the highest quality advice on regulatory issues to members of project teams and its clients by maintaining awareness of current regulatory legislation, guidance and practice related to RA, IRB/EC and Third Body submissions
- Where applicable and if suitably experienced, provide guidance and regulatory expertise on the application of the EU CTR in CTIS to other stakeholders. Manage applicable user access to CTIS and act as a backup in case of unexpected absences of other team members
- Review and input into required Start Up project plans. Distribute, implement and monitor compliance to Start Up project plan with respect to RA/IRB/ EC/Third Body submissions
- Ensure responsible deliverables are met within required timelines maintaining awareness of Green Light (GL) approval and Site Ready to Enroll (RTE) milestones. Proactively identifying and escalating to Start-up Lead any risk to meeting deliverables. Manage projects according to the billing guide to ensure the work is performed within budget. Notify the Start-Up Lead of hours identified as Out-of-Scope or over bur.
- Provide support to Business Development, including providing information for RFI and RFP responses, and bid defense meetings. Attend bid defense meetings if required
- Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met. Initiate improvements to enhance the efficiency and the quality of the submission work performed on assigned projects. Support audits (internal and external) and inspections, as needed. Support resolution of any findings
- Present/attend at external and internal meetings including, but not limited to: project core team and client meetings, Pre-Post Award Transition (PPAT) and Time Expectations Meetings (TEM), Kick Off Meetings (KOM)
- Contribute to the development of the group through participating and leading in process improvement initiatives, e.g. developing and updating SOPs
- Develop the materials for mentoring and coaching other Site Readiness team members
Labcorp is proud to be an Equal Opportunity Employer:
- Minimum of 5 years' experience in the Pharmaceutical industry in Regulatory Affairs or Drug Development
- Excellent communication, organization and planning skills with an attention to detail
- Direct supervisory and project management skills and ability to work independently
- Understanding of and ability to determine relevance of governmental regulatory processes and regulations as they pertain to investigational drug regulations in particular
- Bachelor's degree or higher
- Fluency in English
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
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