- Highmark Health (Raleigh, NC)
- …team of specialists. Identify, develop, coordinate, and implement legislative, regulatory , sub- regulatory , and licensing / accreditation requirements.Perform ... ongoing monitoring and analysis of external regulatory and industry intelligence, collaborating with impacted stakeholders, and providing regular, executive… more
- Novo Nordisk (Durham, NC)
- …Risk Management + Make decisions on quality & compliance issues with little guidance + Participate in process group activities as assigned & leads local ... Site regarding quality & compliance related activities + Facilitate sharing of regulatory & compliance expectations + Follow all safety & environmental requirements… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …the health authority. - Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- MetLife (Cary, NC)
- Key Responsibilities: * Provides subject matter expertise, strategic direction, and guidance on customer, regulatory , and industry information security ... environment. This includes aligning to security control frameworks and guidance such as but not limited to, NIST (800-53,...Privacy, and SSAE-18 SOC1 & SOC2. * Provides customer assurance by responding to B2B customer security questionnaires, ad… more
- IQVIA (Durham, NC)
- The Senior Director of Bioanalytical Laboratory Operations is responsible for operational management and bioanalytical immunoassay support of PK/PD and ... for operational delivery, including ownership of budget, capital planning and P&L. The Senior Director will have a high level of responsibility for the conduct of… more
- Lumen (Raleigh, NC)
- …manager to bolster and drive our compliance programs. Reporting to the Senior Director Security for GRC and Business Enablement, the information Security Governance ... our external and internal obligations. This role will be expected to provide guidance and make determinations relevant on controls that govern the steps, methods, or… more
- Prime Therapeutics (Raleigh, NC)
- …It fuels our passion and drives every decision we make. **Job Posting Title** Senior Internal Auditor - Remote **Job Description** The Senior Internal Auditor ... fostering strong cross-functional relationships and delivering risk-based insights, the Senior Internal Auditor helps drive informed decision-making and support… more
- Edwards Lifesciences (Raleigh, NC)
- …with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize ... and be part of our inspiring journey. As the ** Senior Specialist, Commercial Clinical Imaging** , you will be...and other imaging modality acquisition and interpretation and provide guidance on case planning strategy execution. + Responsible for… more
- Deloitte (Raleigh, NC)
- …with a well-respected team of proven innovators! Work you'll do: As a Senior , you will identify eligible federal C&I generating activities and manage and facilitate ... member firms - Tax, Advisory, Consulting, and Audit and Assurance . The ideal candidate is invested in the team's...process improvements and opportunities for new services. The Tax Senior will ensure accurate, timely completion of deliverables. The… more
- Cardinal Health (Raleigh, NC)
- …on those requirements. + Uphold quality standards that adhere to company, regulatory , and HIPAA policies and procedures. + Collaborate across various functions, ... skills with a proven ability to develop and execute effective quality assurance programs. + Works independently within established procedures; may receive general … more
- Bausch + Lomb (Raleigh, NC)
- …B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance , Pharmacovigilance/GPSS and Drug/Device ... completion of clinical studies according to applicable regulations and guidance , ICH and GCP, and Bausch & Lomb SOPs...are being met and provide the operations director and/or senior management with timely updates on progress and changes… more
- IQVIA (Durham, NC)
- …with complex projects requirements. Serve as a Subject Matter Expert (SME) and provide guidance on focused areas and regulatory requirements as it relates to, ... and text) as required to ensure rapid, seamless, tailored responses to opportunities, under guidance of senior team members, CEVA oversight or line manager as… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible ... complements that of the Global Quality function. The leader shall provide guidance , strategic direction, and leadership to the Global Quality function with… more
- Fujifilm (Holly Springs, NC)
- …Manager handles an average load of 1-3 programs and receives coaching & guidance from the Senior Director, Global Program Quality. **Company Overview** FUJIFILM ... that the quality agreement is organized based on segments of work and regulatory requirements including FDA, EU, and other regulatory agencies * Coordinates… more
- Fujifilm (Durham, NC)
- …Officer, (FUJIFILM Life Sciences) FFLS Corporate Quality Office is proactive senior level position designed to provide proactive compliance oversight through ... into opportunities for growth while maintaining consistency, accountability, and regulatory excellence across the organization. **Company Overview** The work we… more
- ICON Clinical Research (Raleigh, NC)
- …direction and decision-making processes, and offer expert medical and scientific guidance , leveraging therapeutic expertise to inform project development. **What You ... Will Be Doing:** + Providing strategic medical leadership and guidance on project teams. + Offering expert medical and scientific consultation throughout project… more
- Merck (Durham, NC)
- …Action Management, Annual Product Review Authoring, and Quality Council. The ** Senior Specialist, Quality Assurance ** will be primarily responsible leading ... **Job Description** The Senior Specialist, Quality serves as a member of...to adherence to compliance requirements + Direct support of regulatory inspections and audits, including presentation/defense of Deviation and… more
- Prime Therapeutics (Raleigh, NC)
- …decision we make. **Job Posting Title** MTM Specialist Sr **Job Description** The Senior Medication Therapy Management (MTM) Service Specialist will act as a Subject ... of the MTM programs in addition to assisting the leaders with Quality Assurance , training and daily tasks as needed. **Responsibilities** + Receive inbound and make… more
- Evolent (Raleigh, NC)
- …decision-making. + Act as a key resource for Initial Clinical Reviewers, offering guidance and expertise to ensure the application of best practices. + Provides ... with requesting physicians or ordering providers, when available, within the regulatory timeframe of the request. + Utilizes medical/clinical review guidelines and… more