- 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
- Catalent (Philadelphia, PA)
- …Philadelphia, PA is hiring a QA Supervisor. The QA Supervisor will p rovide Quality Assurance support for the Quality Inspectors on the production floor, ... incoming material quality , and/or distribution quality , including quality oversight for material management of materials at Catalent-Philadelphia. Assist in… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... relationships, developing and maintaining strong communication channels. Leads successful investigator and strategic partnership negotiations in accordance with all… 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)
- …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
- 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
- BioAgilytix (Boston, MA)
- …reports, and other documents. He or she ensures the timely delivery of high- quality documents for sponsors and internal team members. We are looking for candidates ... the project manager (eg, Bioanalytical Project Manager (BPM), Principal Investigator ).Responsible for maintaining collaborative, direct contact relationships with internal… more
- Merck & Co. (North Wales, PA)
- …and execute scientific input Consulting Agreements and our company's Investigator Studies Program (MISP) agreements; and/or negotiate and execute licensing ... contracting process.Support departmental initiatives including filing, metric reporting and quality control. Position Qualifications : Education Minimum Requirement: A… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... of investigators for clinical studies and provide medical support to investigator meetings Provide protocol training, disease specific training and titration… more
- Aequor (NJ)
- …during phases 1-4. The individual must partner closely with clinical, regulatory, quality and production associates to ensure timely delivery of supplies to study ... Working with third party vendors to ensure the timely, efficient, high quality , cost effective execution of all outsourced clinical supply activities. Ensuring… 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
- 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
- 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
- BioAgilytix (Durham, NC)
- …medicine performance within specific contexts. Our commitment to data integrity and quality is unwavering, and you'll be instrumental in upholding these standards ... needs based on projected project needsMay serve as principal investigator on a projectMay prepare and submit deviationsManage project timelines/schedulingManage… more
- Tris Pharma (Monmouth Junction, NJ)
- …with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality , etc. to identify, evaluate and communicate safety observations. ... while working collaboratively with key internal and external stakeholders to ensure high quality submissions are made to the Food and Drug Administration (FDA) to… 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 regulatory strategy for assigned programs to ensure timely and high- quality regulatory deliverables to the GPTs Lead health authority interactions, including… more
- George Washington University (Ashburn, VA)
- …multiple sites across the US. The Project Manager works with the Principal Investigator and Co-Principal Investigator (at another university) to ensure that the ... project meets milestones on time, within budget, and meets all quality standards. This role requires strong leadership, organizational, and communication skills, as… more
