- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Lead of the Case Processing Team and Patient Safety Management Team. FDA AND ICH COMPLIANCE : Applies knowledge of industry regulations and practices ... maintenance, retention and archiving of all Patient Safety records. Serves as support to the management...with at least five years of experience in the patient safety area preferred. Supervisory management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …day to day operations with a focus on operational excellence in support of patient needs Lead design, implementation and ongoing management of all Rare Disease ... brand management /marketing and/or sales/operations experience required Agency/Vendor management experience required Patient Support Operations experience… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …assessments to prioritize investigations based on potential impact on product quality, patient safety , and regulatory compliance . Address recurring ... based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …SDEA requirements. Relationships This position reports to the Director, Case Review & Compliance Reporting within Patient Safety . This position works closely ... to the following: all units in Patient Safety , NNI GXP Support, NNI Legal, NNI Compliance...Safety PV Oversight System Monitors and manages the Patient Safety Contracts Management mailbox.… more
- Tris Pharma (Monmouth Junction, NJ)
- …for the development of ad hoc aggregate safety reports, periodic safety reports, signal detection activities and risk management planning. The incumbent ... agreements with appropriate business partners and assumes accountability in ensuring compliance with safety data exchange activities Reviews and/or contributes… more
- Novo Nordisk Inc. (Atlanta, GA)
- …The Position Drives the understanding and delivery of quality clinical research ( patient safety , rights and wellbeing; data reliability; scientific integrity; ... us all marching to the same beat is our patient -centered focus. At Novo Nordisk, you will help patients...regulatory and process compliance ) for monitoring and site management activities.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …competencies, tools, and technology. Maintains responsibility for quality, performance, regulatory compliance , and patient safety related to managing ... us all marching to the same beat is our patient -centered focus. At Novo Nordisk, you will help patients...assigned clinical trials, document management and management of clinical trial management systems and… more
- Northeast Georgia Health System, Inc (Oakwood, GA)
- …Safety Specialist will support the NGPG Patient Safety & Risk Management programs by monitoring compliance with established patient safety ... training to staff and providers related to risk management , patient safety , and HIPAA/ compliance review assistance (when authorized). Minimum Job… more
- Eisai, Inc (Nutley, NJ)
- …NAS will be responsible for ensuring customers are educated on the simplest patient journey to therapy within their assigned geography. The individual must be able ... NAS will be required to effectively understand, navigate, and communicate a successful patient pathway to customers.The NAS will be an agile learner with the… more
- Catalent (Philadelphia, PA)
- …Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient , consumer, and Catalent ... quality, and/or distribution quality, including quality oversight for material management of materials at Catalent-Philadelphia. Assist in the enforcement of… more
- Catalent (San Diego, CA)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient , consumer, and Catalent ... the General Manager to create and sustain a site culture of Safety , Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trial sites when directed by management to check principles of assuring patient safety , data integrity and regulatory compliance are sufficient Monitor ... us all marching to the same beat is our patient -centered focus. At Novo Nordisk, you will help patients... compliance signals and issues to GxP Support management Physical Requirements 40-50% overnight travel required. 40-50% overnight… more
- Catalent (San Diego, CA)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient , consumer, and Catalent ... and scientific reasoning ability to identify aberrant data and potential quality/ compliance concerns escalating to management .Excellent written and verbal… more
- Catalent (Philadelphia, PA)
- …Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient , consumer, and Catalent ... initiation date.Release batch within scheduling database.Communicates SQDC countermeasures and safety issues to Quality Management .Ensures QADC metrics are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical support for scientific symposium and medical congresses within legal and compliance regulations.Works with Patient Advocacy leads and Grants office to ... of the activities in the GMA plan including Launch Readiness and Life Cycle Management for the assigned compound and will report into the Global Oncology Medical… more
- Catalent (San Diego, CA)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient , consumer, and Catalent ... assistance when needed to prevent deviations and investigationsDevelop time management strategies to ensure work is performed within required timelinesParticipate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …effectuating all business assurance initiatives including but not limited to utilization management controls, 340B compliance , and contract compliance . ... by the customer Provides analysis support around commercial rebate exclusions, formulary compliance , and utilization management controls and reports out to… more
- Catalent (Manassas, VA)
- …Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient , consumer and Catalent ... the site and across the company. Leads site-level initiatives for supplier management , supplier quality & supplier performance improvement as well as supports global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …interacts with multiple NNI internal functions, such as Omnichannel Marketing, brand management , Patient Support, IT Operations, IT Quality, and Novo Nordisk ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Catalent (Harman, WV)
- …customer requirements. They are responsible for establishing and maintaining the site metrics, management review, and building a Patient First culture at the ... for setting the strategic direction, properly staffing, and maintaining the Quality Management Systems (QMS) to ensure the site is compliant with regulatory,… more
