- Novo Nordisk Inc. (West Lebanon, IN)
- …Are you ready to realize your potential? The Position The Deviation Investigator -Writer is responsible for investigating and writing of deviations to the ... merit and completeness according to regulatory expectations. The Deviation Investigator -Writer will be responsible for initiating investigations and writing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. SummarySupport the PVQA quality strategy and quality plan with specialty and the Oncology ... Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical conduct… more
- Axelon Services Corporation (Bothell, WA)
- …overseeing and supporting the management of deviation records through the electronic quality record management system at the Juno Manufacturing Plant (Jump) located ... in Bothell, WA. The Deviation Investigator on the MSAT team is an individual contributor...in the Jump MSAT team and a champion for quality priority principles and compliance within the Jump organization.… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document Control ... committed to a Patient First culture through excellence in quality and compliance, and to the safety of every...related to batch record documentation and release.Act as lead investigator for all Problem Reports regarding batch record documentation… more
- Amerantbank (Miramar, FL)
- …to completion of high risk account reviews with minimal supervision.Able to produce top quality investigative cases that can be held to high standards of quality ... and accuracy.Able to work in a highly dynamic and fast paced environment.Read and understand the bank's BSA/AML Program Policies and Procedures and ensure the Program's high standards are maintained.Possess excellent communication and writing skills.Ensure… more
- MultiPlan (Atlanta, GA)
- …The incumbent will assist department leadership in managing productivity and achieving quality and revenue goals as well as mentoring more junior department team ... when appropriate. JOB ROLES AND RESPONSIBILITIES: 1. Achieve measured production, quality , and growth results.2. Utilize analytics, data mining, and coordination of… more
- MultiPlan (Atlanta, GA)
- …errant claim payments. JOB ROLES AND RESPONSIBILITIES: 1. Achieve measured production, quality , and growth results. 2. Utilize analytics and data mining and ... coordination of benefits techniques to client paid claims data.3. Evaluate medical claims for coding and pricing errors using accurate HCPCS, ICD-10, and CPT codes. 4. Lookup and review medical claims in payer system to determine methods of payment and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and execution (from planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the oversight of and ... party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is suitable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Leadership Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including ... study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr.… more
- Eisai, Inc (Nutley, NJ)
- …and external medical writers for development and integration of highest quality medical content.Provide medical expertise and tactical input into the overall ... publication materials are accurate, compliant, balanced, and of the highest quality ; Work with cross-functional teams and ensure that all communication materials… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to ... global project teams. This role will be a senior member of the Regulatory, Quality and Clinical Reporting (RQC) team, and will provide mentorship and coaching to… more
- Merck & Co. (Rahway, NJ)
- …within industry leading performance cycle times, unwavering quality and operational efficiency.Oversight of subordinate personnel/activities.Required Education: ... clinical research setting.Business acumen and/ or financial background; preferably Investigator grants and payments.Strong understanding and dedication to our… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... potential? The Position The Deviation Leader/Coordinator is responsible for the quality and oversight of the deviation investigation and CAPA (corrective actions… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to ... include: Clinical study protocols and protocol amendments Clinical study reports (CSR) Investigator brochures (IB) Informed consent and assent forms Lay summaries of… more
- Eisai, Inc (Nutley, NJ)
- …assessment of Eisai Neurology products, and will be responsible to deliver high quality and impactful models to ensure optimal patient access. In addition, the ... incumbent will ensure quality is maintained in all aspects of technical work...and vendors, develops and maintains client relationships.As project lead/principal investigator has project budget, deliverable and timeline responsibility; identifies… more
- Eisai, Inc (NJ)
- …As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the ... clinical sections of submissions documents such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reportsPrepare and review marketing… more
- Eisai, Inc (Nutley, NJ)
- …Safety staff for all marketed and investigational Eisai productsDesigns and conducts quality reviews to verify the accuracy, completeness and validity of information ... of coding practices among International offices.Interface with Clinical for investigator training Essential Functions Adverse event information collection, processing,… more
- Taiho Oncology (New York, NY)
- …and Taiho's product(s) and compounds to ensure awareness and understanding. Provides high- quality scientific information to HCPs. Serves as a conduit for accurate ... collaboration with Medical Affairs personnel supports data generation in Investigator -Initiated Trials (IITs) and SL/HCP initiated projects. Facilitates the review… more
- BioAgilytix (Boston, MA)
- …according to GxP guidelines)Essential Responsibilities: Data Review & DocumentationPerform Quality Control (QC) technical and scientific and compliance review of ... by the project manager (eg, Bioanalytical Project Manager (BPM), Principal Investigator )independently creating reports, plans, and submission documents in support of… more
- Taiho Oncology (TX)
- …product(s) and compounds to ensure awareness and understanding. Provides high quality scientific information to healthcare professionals (HCPs) Serve as a conduit ... In collaboration with Medical Affairs personnel support data generation Investigator -Initiated Trials (IITs) and HCP initiated projects. Facilitate the review… more
