- J&J Family of Companies (Wilson, NC)
- …standards. + Understanding and experience in application of global regulatory ( FDA , EMA, etc.) guidelines in a biological or pharmaceutical manufacturing ... environment. + Specific Experience as the person responsible for Batch Release (QA Specialist, Release) **Key Competencies - Other requirements** + An unquestionable level of integrity and commitment to operating ethically and within the boundaries of… more
- Aerotek (Danvers, MA)
- …Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA regulations. **Shifts:** + 2nd shift - 3:30 pm to 11:30 pm + ... A 5-7 week training period is provided **Essential Skills** + Attention to detail + Hand dexterity + Ability to learn and be trained on new skills and equipment + Experience with microscopes is preferred + Experience in cleanroom, medical device, or… more
- Mentor Technical Group (Aibonito, PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six… more
- ThermoFisher Scientific (Wilmington, NC)
- …reporting, and interpretation of statistical data. . Stay current with ICH, FDA , and global regulatory guidance. Represent the Department Externally . Deliver ... compelling capabilities presentations to prospective clients. . Collaborate with Business Development and Contracts teams to support bids, budgets, and proposals. Shape Medical Writing Strategy & Processes . Contribute to the development, evaluation, and… more
- Trinity Health (Des Moines, IA)
- …payable diagnosis codes/medical necessity and prior therapy requirements according to FDA and NCCN guidelines. Assists patients in financing, payment plans, ... financial assistance and all financial options through the organization. This includes grants, co-pay assistance for high-cost pharmacy/drugs and free-drugs for infusion and specialty care patients. Monitors assigned patient accounts through entire revenue… more
- J&J Family of Companies (San Angelo, TX)
- …andexpertisein quality processes and regulatory requirements. + Experience working in an FDA regulated environment preferred (21 CFR Part 211 and 211, 21 Part ... 820, ICH Q7 and/or 21 CFR Part 4) + Basic wet chemistry techniques related to qualitative and quantitative + Mustbe flexible with a variety of working situations and schedules. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will… more
- Boehringer Ingelheim (Los Angeles, CA)
- …products. + Performs all company business in accordance with all regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and company policy and procedures. + ... Immediately reports noted/observed violations to management. + Demonstrates high ethical and professional standards with all business contacts to maintain BIPI's excellent reputation within the medical and pharmaceutical community. **Requirements** +… more
- Edwards Lifesciences (Irvine, CA)
- …+ Experience with Software as a Medical Device (SaMD) and regulatory compliance ( FDA , ISO 13485, IEC 62304) + Familiarity with cybersecurity, data privacy (HIPAA), ... and interoperability standards (FHIR, HL7) + Experience with data pipelines, ETL processes, and data structuring for digital health or software products + Exposure to AI/ML workflows and how structured data support predictive modeling + Experience working with… more
- J&J Family of Companies (Palm Beach Gardens, FL)
- …manufacturing/operations. + In-depth knowledge of product/process Risk Management (MDSAP, MDD, MDR, FDA and ISO standards) + Experience and a proven track record of ... implementing appropriate risk mitigation **Preferred:** + Advanced knowledge of Six Sigma methodologies. + Understanding of the NPI (New Product Introduction) process **Other:** + This position will require less than 10% travel _Johnson & Johnson is an… more
- Lundbeck (Tyler, TX)
- …including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. ... **REQUIRED EDUCATION, EXPERIENCE and SKILLS:** + Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university + 2-5 years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience. +… more