- BioAgilytix (San Diego, CA)
- … systems and softwareAuthors and reviews validation deliverables (risk assessment , requirements specification, IQ/OQ/PQ, etc.) Contributes to the development and ... less than three (3) years' direct hands-on experience with computer systems validationMinimum Preferred Qualifications: SkillsProficiency in Computer System … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …technical issues associated with specific projects Operates common tools and systems for vulnerability assessment , penetration testing, network intrusion ... of IT security strategy and serving as a security advisor to ensure IT systems are implemented and maintained to the highest security standards. Individuals in this… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focus, for supporting and upholding processes anchored in the NN Quality Management System (QMS) across NAO thereby ensuring highest quality to patients. This role ... Reports to head of NAO Quality PV Oversight Vendor Assessment Team and is an individual contributor role. Maintains...and leverages relationships with HQ SMEs, process management, and system management to influence process and system … more
- Novo Nordisk Inc. (Langhorne, PA)
- …to achieve the fulfilment of Plan objectives/requirements. This includes delivery-of-care system delineation, account targeting, needs assessment , and program ... data Monitor and reinforce the use of the Sales Force Automation System Communicate Regional activity of competitive products through timely submission of monthly… more
- Merck & Co. (North Wales, PA)
- …to meet the value evidence needs of payers, advisory committees health systems , and clinicians.The incumbent can generate these plans based on direct interactions ... on research design and implementation of retrospective database studies, assessment of patient reported outcomes, epidemiological studies and economic modeling.The… more
- Merck & Co. (North Wales, PA)
- …the value evidence needs of clinicians, payers, policymakers, health technology assessment (HTA)/reimbursement agencies and health systems globally.Types of ... Management, Epidemiology, Health Economics, Health Outcomes Research, Health Technology Assessment (HTA), Management Process, Marketing Strategies, Medical Affairs, Neuroanatomy,… more
- Merck & Co. (Upper Gwynedd, PA)
- …for the delivery of all regulatory milestones through product development including assessment of the probability of regulatory success together with risk mitigation ... of global product and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for impact assessment . Participates in the review and management of monthly, quarterly, and ... and inspection readiness activities. Provide input for re mediating PV system deficiencies cited in audit/inspections. Manage the implementation of effective… more
- Twist BioScience (South San Francisco, CA)
- …using LLMs.Analyze output from wet lab assays (expression, binding data, developability assessment , etc.) and process large, high content datasets to produce data ... formats (eg, FASTA, FASTQ).Basic understanding of cloud computing, workflow management systems , and CI/CD pipelines.High interest in learning and contributing to… more
- Insmed Incorporated (San Diego, CA)
- …process development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the ... teams to ensure accurate and reliable analytical data. Performs technology assessment to enable high throughput analyses, automation opportunities, and easy to… more
- Tris Pharma (Monmouth Junction, NJ)
- …and operations, contract negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and ... storage and distribution of materials and products; Implements inventory control systems to maintain optimal stock levels and minimize obsolescence; Ensures… more
- Aequor (Houston, TX)
- …Analysis (RCA) to determine the most likely cause of the deviation investigation, assessment of event for impact to Safety Identity Strength Quality Purity (SISQP), ... varying difficulty. Attendance and occasional leadership of the daily management system and participating/leading the deviation review board. Perform other duties as… more
- Aequor (Thousand Oaks, CA)
- …CA, and requires the ability to lift 50&plus pounds and pass a vision assessment for inspection work. Candidates must be comfortable working with raw materials and ... communication skills Time management Proficient computer skills (ie documentation systems , databases and spreadsheets). Bachelor's degree OR Associate's degree and… more
- Merck & Co. (Rahway, NJ)
- …development assessments on an ad-hoc basis.Collaborate with Policy colleagues in the assessment of and development of action plan to shape the value frameworks ... marketing (or equivalent roles), market researchStrong understanding of healthcare systems , reimbursement methods, and policy issues, including health technology… more
- Genmab (NJ)
- …labeling documents; Maintain and track labeling documents in the electronic system as appropriate.Participate in the development and maintenance of SOPs, work ... process for dissemination of regulatory intelligence and subsequent impact assessment within GenmabWork closely with the global regulatory leads (GRLs),… more
- Merck & Co. (Rahway, NJ)
- …needs of clinicians, payers, policymakers, HTA/reimbursement agencies, and health systems globally.Types of studies executed include prospective and retrospective ... The incumbent may have direct interactions with health technology assessment (HTA) agencies, reimbursement decision makers, or national immunization technical… more
- Merck & Co. (Rahway, NJ)
- …results. Reviews and defends stage-gate deliverables for programs including risk assessment and mitigation plans and engages in corporate governance meetings ... Business, Compliance Investigations, Confidentiality, Cross-Cultural Awareness, Detail-Oriented, Document Control Systems , Electronic Common Technical Document (eCTD), Ethical Compliance, Global… more
- CenterLight Health System (Ridgewood, NY)
- …will follow all Department of Health policies and regulations pertaining to the Uniform Assessment System of New York (UAS-NY) as well as Intake workflows ... assessment appointments with prospective or enrolled participants (utilizing the Uniform Assessment System of New York, UAS-NY). During this visit, answers… more
- Texas A&M University System (Laredo, TX)
- …, data analysis and educational outcomes. + Experience managing and using assessment software systems . + Demonstrated ability to synthesize and analyze ... Survey design, methodology and implementation Ability to: + Manage and use assessment software systems . + Prepare and present reports effectively.… more
- System One (Bellevue, WA)
- …Model: Fully Remote System One is hiring a Principal Probabilistic Risk Assessment (PRA) Engineer with at least 15 years of experience for a long-term, fully ... Job Title: Principal Probabilistic Risk Assessment Engineer Location: Remote Type: Contract (yearlong) Compensation: $102 - $130 hourly Contractor Work… more
