- ITG Brands (Greensboro, NC)
- Director , Regulatory Science **Location** North Carolina **City** Greensboro **Role Type** Permanent **WHO WE ARE** ITG Brands is the third-largest tobacco ... documents. - PREFERRED QUALIFICATIONS: + Experience with FDA interactions and regulatory negotiations. + Familiarity with behavioral science , exposure… more
- Merck & Co. (Durham, NC)
- Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across the full value chain for a late-stage ophthalmic program. In this role, ... excellence from development through commercialization. You'll partner across Quality, Regulatory , Technical, and Supply Chain teams-coaching, facilitating, and removing… more
- GRAIL (Durham, NC)
- …of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's ... a key member of the Quality Leadership Team, the Director of Quality Audits will be responsible with overall...state of readiness. + Manage and support the external regulatory compliance inspections (CAP, NYSDOH, FDA, IVDR), responses, and… more
- WCG Clinical (Cary, NC)
- Senior Director , Product Management & Strategy (Remote) **General Information** **Location:** Cary, NC, Remote **Organization:** WCG **Job Type:** Full Time - ... clinical trials. WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to develop new products and therapies… more
- GRAIL (Durham, NC)
- …of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's ... For more information, please visit grail.com . Reporting to the Senior Director , Quality Strategy & Operational Excellence, the Senior Quality Specialist is… more
- GRAIL (Durham, NC)
- …of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's ... For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal… more
- Lilly (Durham, NC)
- …to make life better for people around the world. **Responsibilities** The Senior Director , Global Process Owner for Quality Risk Management, as a leader within the ... manufacturing facilities, external supplier organization, marketing affiliate quality operations, regulatory , research and development and other functions to educate… more
- United Therapeutics (Research Triangle Park, NC)
- …IND, CTA, NDA, MAA, and agency meeting packages) + Knowledge of GCP and regulatory guidelines + Knowledge of clinical science as applicable to drug development ... is not currently an option. **Who You Are** The Director , Strategic Development will support development and execution of...to successful product approval by the FDA and other regulatory agencies. + Design and review clinical protocols, data… more
- CREO (Durham, NC)
- JOB DESCRIPTION OVERVIEW The Director , Technology Strategy and Solutions, is a high visibility client-facing leader responsible for a book of business and products ... project delivery and team leadership. Within CREO's seller-doer model, the Director must operate with excellence in business development, client service, and… more
- IQVIA (Durham, NC)
- **Associate Technology Solution Sales Director -eQMS (SmartSolve) & Quality Consulting** The Associate Technology Solution Sales Director will focus on promoting ... to manage complex sales cycles and ultimately acquire new customers in life science . This position supports continued growth following last year's 20% increase in… more
- IQVIA (Durham, NC)
- **Summary:** We are looking for a strategic and hands-on Director of Architecture to lead the end-to-end architecture of our Clinical Data Analytics Suite (CDAS). ... with life sciences regulations (eg, GxP, HIPAA, 21 CFR Part 11). The Director will partner with cross-functional teams to establish design standards, enable modern… more
- MetLife (Cary, NC)
- …while maintaining performance. . Security & Compliance: Ensure adherence to regulatory requirements and best practices. . Performance & Reliability: Continuously ... financial stewardship. . Security & Compliance: Protection against threats and regulatory alignment. . Reliability & Performance: High availability and operational… more
- UNC Health Care (Morrisville, NC)
- …of the unique communities we serve. **Summary** : The **Executive System Director of Utilization Management (UM)** is a strategic and operational leader responsible ... to ensure clinically appropriate level of care, optimal patient flow, regulatory compliance, and effective and efficient management of healthcare resources in… more
- ThermoFisher Scientific (Morrisville, NC)
- …(Mon-Fri) **Environmental Conditions** Office **Job Description** **Business Title:** Sr Director , Procurement - Global Professional Services & Enterprise Strategies ... here to achieve your career goals and help take science a step beyond by developing solutions for some...continuity + Applies AQSCIR (Assurance, Quality, Service, Cost, Innovation, Regulatory ) method to develop and drive 3 to 5… more
- Wolters Kluwer (Cary, NC)
- …technology, aligned with organizational policies, and scalable to meet evolving regulatory and business requirements. The position partners with security leadership, ... able to balance risk, efficiency, and business needs. + Familiarity with regulatory requirements in multiple jurisdictions (eg, EU, US, APAC). + Knowledge of… more
- IQVIA (Durham, NC)
- …and Client Engagement:** + Leverage IQVIA medical, scientific, operational and data science experts to determine the optimal solution, project design and lead a ... trial delivery + Robust and current knowledge of scientific, clinical, regulatory , commercial and competitive landscape in applicable therapeutic area + Strong… more
- CenterWell (Greensboro, NC)
- …caring community and help us put health first** Reports To: Associate Director , Home Health Branch Administrator FLSA: Exempt **Work Schedule** : Full-time/40 Hours ... (POC). + Monitors cases to ensure documentation is in compliance with regulatory agencies and requirements of third-party payers. Ensures final audits/billing are… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …met for BD's portfolio of products. Reporting to the Product Security Sr. Director , this individual will help the PSO provide guidance to successfully deliver ... best-in-class secure products, consistent with global regulatory requirements over the lifecycle. This role works in partnership with R&D, Enterprise Security,… more
- Gentiva (Burlington, NC)
- …Hospice Patient Care Manager, You Will:** * Report directly to the Executive Director , Administrator, or Senior Patient Care Manager * Oversee and direct patient ... and compliance * Ensure all care delivery meets federal, state, and local regulatory standards, as well as company policies and procedures * Support performance… more
