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Experience with MES infrastructure, ALM and Veeva document/change management systems and middleware WebMethods. Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
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With advanced technical document writing and time management skills, including ability to prioritize and manage expectations. Minimum 50% onsite required every week(Candidate is supposed to align the onsite days with manager and be available onsite when manager requests.
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The Field Reimbursement Manager will be responsible for the management of defined accounts in Urology and Oncology area, specifically supporting our clients product. Demonstrated level of proficiency with support technology (e.g., PC, tablet, & Customer Relationship Management (CRM) tools.
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Job Description: Minimum 50% onsite required every week(Candidate is supposed to align the onsite days with manager and be available onsite when manager requests) The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing.
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SnowflakeSource Code Management tools and best practices (similar to: Git, Git Actions, branch management)Working knowledge of:CI/CD Pipelines (similar to: Jenkins, UCD)Process Orchestration Tools (similar to: AutoSys, Airflow, Step Functions )Infrastructure as Code (similar to: Terraform, CloudFormation)DatabricksPython/PysparkWhat is a Must Have.
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Ranked one of the top 100 top RIAs by Barron’s & Forbes and headquartered in Parsippany, New Jersey with several regional offices across the country, Summit Financial LLC is a ~$10 billion independent advisory firm that has been providing comprehensive financial planning and wealth management services to high-net-worth individuals for over 40 years.
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The Care Coordinator is a critical role designed to facilitate and enhance telemedicine services, including Remote Patient Monitoring (RPM) and Chronic Care Management (CCM), for patients residing in Skilled Nursing Facilities (SNF.
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The Internal Audit Intern position is built for candidates who would like to build experience in business, accounting, finance and/or Enterprise Risk Management (ERM). Internal Audit Evaluates The Adequacy And Effectiveness Of All Worldwide Internal Control Processes On a Rotating Basis Considering Significance And Risk As a Service To Senior Management And The Board Of Directors.
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The Senior Fire Protection Engineer will lead the team in the design work on multi-discipline projects and lead the preparation of comprehensive fire protection packages including fire suppression, fire alarm, smoke management, and life safety.
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Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in drug development processes and post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a solution-oriented approach to problem solving Ability to plan/prioritize work of group members and guide/develop others.
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The Manager, CAR-T Site Materials Buyer & Planner will be responsible to develop a materials purchasing strategy including, target weeks of supply, reconciliation of material, safety stock, reordering point quantities, forecast, supplier relationship management, and the enhancement of department Key Performance Indicator (KPI) and metrics.
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We provide our clients with solutions in every phase of their cash supply chain, including secured transportation, cash management, cash vault processing, forecasting, ATM, and cash recycler services.
$16.9 - $17.9 an hourFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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You will make sales calls to infertility specialists (IVF Doctors/reproductive endocrinologists), embryologists, nurses, and account/clinic/center management team and administration. You will pass both interim and final examinations and demonstrate to Training and Sales Management that their clinical and product knowledge, proper use and clinical applications of all Products is within Company Standards.
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Collaborate internally across Accredo Specialty Pharmacy, Care Coordination, eviCore Medical Benefit Management, Express Scripts PBM, and Cigna Payer Solutions teams and related solutions to maximize value to the client/prospect.
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Defining vision and executing strategy for continued compliance and increased efficiency of Quality Management Systems, including improved investigations processes, CAPA effectiveness, etc.
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risk management jobs Title: compliance manager in East Hanover, NJ
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