- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... track for experience in Advertising and Promotion. The fellow will learn about FDA regulations, including compilation and submission of any required documents to … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... clinical overviews, formulary dossiers, online evidence repository). Ensure compliance with FDA requirements as they affect medical communications; responses must be… more
- Tris Pharma (Monmouth Junction, NJ)
- …standards.Essential Job Functions: Carries out responsibilities in compliance with all cGMP, FDA , DEA, and OSHA regulations, as well as all applicable company ... up and operating UV/IR, HPLC, GC, TLC and dissolution apparatusWorking knowledge of FDA and cGMPs regulations and guidances as well as DEA and OSHA… more
- Lundbeck (Boston, MA)
- …and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. ... healthcare economy and industry practices. Accountability and adherence to corporate, FDA , and PDMA guidelines.REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements for CSV projects. Work within a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and ... Manufacturing Practices (GAMP5) and Good Practices Guides, Risk-Based Approach/Computer Software Assurance (RBA/CSA) to assure related Daiichi Sankyo business needs… more
- Aequor (Bothell, WA)
- …Abilities:Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices.Comprehensive ... knowledge of SOPs, cGMPs, and other compliance requirements and regulatory guidelines ( FDA , EU) and the know-how to work and manage within a regulatory… more
- BioAgilytix (Durham, NC)
- …projects spanning business systems, laboratory systems (ELN, LIMS), and IT hardware/ software implementations. You will drive successful project outcomes by ensuring ... LIMS).Experience with ITIL-based processes and frameworks.Experience in regulated environments (eg, FDA , GMP, GDPR compliance, GAMP, etc.) and familiarity with IT… more
- Lundbeck (San Diego, CA)
- …accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED ... communication skills Must be computer literate with proficiency in Microsoft Office software Must live within 40 miles of territory boundaries Driving is an… more
- Merck & Co. (Durham, NC)
- …training programs in the principles of computerized systems validation, computer software assurance, and regulatory requirements in validation, data integrity, ALCOA ... Must possess strong understanding of the current pharmaceutical industry and applicable regulations ( FDA /EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …etc.).Coordinate and execute MES validation activities according to the Software Development Lifecycle (eg commissioning test Plans (CTP), Installation/Operational ... Investigations, Corrections, and QMS records.Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.This individual is responsible for… more
- Eisai, Inc (Nashville, TN)
- …clinical information to customers and key stakeholders consistent with the FDA -approved indication. Additionally, the NAS will be responsible for ensuring customers ... platform, Outlook, salesforce automation and customer management databases, formulary software and applications (ie FTF), digital communication platformsAbility to… more
- Lundbeck (Detroit, MI)
- …accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED ... customer influence network Must be computer literate with proficiency in Microsoft Office software Must live within 40 miles of territory boundaries Driving is an… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …industry.Proficient computer skills to be able to navigate specialized software and databases.An ability to build strong partnerships and effectively ... to detail and the ability to follow procedures.Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell based products.Ability to lift a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... accuracy review with strong attention to detail. Proficiency in Microsoft Office software applications such as PowerPoint, Excel and Word and overall computer skills… more
- Abbott (Alameda, CA)
- … or embedded firmware under a disciplined product development process that meets FDA requirements. # software **What you'll work on** + Participate in the ... as assigned by management. + Implement approved Design Control procedures for software development in accordance with FDA guidelines. **Required Qualifications**… more
- Abbott (Pleasanton, CA)
- …reporting systems (eg, JIRA). + Experience with FMEA/risk management. + Knowledge of FDA regulations and software guidance, IEC 62304, IEEE 1012, ISO 13485, ... people in more than 160 countries. **Job Title** **Senior Quality Engineer, Software ** **About Abbott** Abbott is a global healthcare leader, creating breakthrough… more
- Fresenius Medical Center (Lawrence, MA)
- …+ Medical device or other safety critical device development + Familiarity with FDA and international software development guidelines and standards + Strong ... **PURPOSE AND SCOPE:** This Senior Staff Software Engineer will play a key role in...our internal Quality System, including specific requirements of GMPs, FDA QSR, IEC 62304, and ISO 9001 standards +… more
- Actalent (Carlsbad, CA)
- … of Unknown Provenance (SOUP) tools or packages are up to date. * Own software -related FDA 510(k) submission documents. * Participate in the design and review of ... Software Quality Assurance Engineer Job Description Responsibilities: *...Diagnostics (DNA sequencing) + SW Quality + V&V + FDA Docs Job Type This is a permanent position.… more
- Actalent (Columbia, MD)
- …ideally in a fast-growing or startup environment. + Regulatory experience in developing FDA -approved medical device software is a plus. Work Environment Small ... Job Title: Software LeadJob Description A rapidly expanding health technology...health technology company is seeking a dynamic and hands-on Software Lead to spearhead the development of innovative healthcare… more
- Stryker (Portage, MI)
- …accordance with internal software development lifecycle requirements in compliance with FDA software development guidance. + Supports the research and design ... Stryker is seeking to hire an electrical engineering or software engineering co-op to support Orthopaedic Instrument's new product...best practices. What You Will Do The electrical or software engineering co-op will aid in the design, development,… more
