- Insmed Incorporated (NJ)
- …to submission.Ensure adherence to global regulatory authority technical requirements ( FDA , EMA, Health Canada, MHRA, etc.) for electronic submissions.Maintain ... tools (eg, Lorenz, GlobalSubmit, Extedo, or equivalent).Strong knowledge of FDA , EMA, and ICH electronic submission standards and guidance.Excellent organizational… more
- Eisai, Inc (Los Angeles, CA)
- …of NASs and then leading demand generation in a manner consistent with the FDA -approved indication to meet or exceed sales objectives. This will be accomplished by ... conveying complex clinical information to customers and key stakeholders regarding FDA -approved indications of this novel therapy. The individual will implement and… more
- Tris Pharma (Monmouth Junction, NJ)
- …(SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration ( FDA ) standards. She/he also provides and monitors the continuous flow of ... is cleaned to meet production schedule and in accordance to strict SOP, FDA and cGMP standardsSupports and assists with daily cleaning functions, as needed (vaults,… more
- Merck & Co. (Rahway, NJ)
- …strategy.Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human ... Factors guidance, ISO 14971, 11608 and 11040, EN 62366, Council Directive 93/42/EEC, etc.Proven track record of applying analytical skills in product design, development, and validationSelf-motivated with ability to work independentlyProven ability to lead… more
- Formation Bio (New York, NY)
- …and resource allocation. Ensure all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk ... and managing complex, multi-center clinical trials. In-depth knowledge of ICH-GCP, FDA regulations, and global clinical trial guidelines. Strong strategic thinking… more
- Legend Biotech USA, Inc. (Baltimore, MD)
- …ethical standards and will adhere to the regulatory requirements of the FDA and other government agency guidelines, without exception. This position will report ... exception, with all corporate policies and procedures as well as all applicable FDA and OIG legal standards and requirements as well as PhRMA guidelinesSpear-head… more
- Insmed Incorporated (NJ)
- …and lab business processes is preferred.Solid working knowledge of CSV guidelines and FDA /EU regulations: 21 CFR Part 11, Annex 11, GAMP 5, GMPs, Good Clinical ... with Veeva QualityDocs /QMS is preferred.Knowledge and understanding of the FDA Computer Software Assurance (CSA) fundamental concepts.Basic understanding of data… more
- Insmed Incorporated (San Diego, CA)
- …understanding of document management principles.Solid working knowledge of CSV guidelines and FDA /EU regulations:21 CFR Part 11, Annex 11, GAMP 5, Good Clinical ... Practices, GMPs, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts.Strong technical writing skills for authoring, reviewing… more
- Insmed Incorporated (NJ)
- …is preferred.Experience with Veeva QualityDocs /QMSSolid working knowledge of CSV guidelines and FDA /EU regulations: 21 CFR Part 11, Annex 11, GAMP 5, Good Clinical ... Practices, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts.Strong technical writing skills for authoring, reviewing and… more
- Insmed Incorporated (NJ)
- …governance frameworks and control structures consistent with NIST and FDA data protection standards.Partner with Legal, Compliance, Clinical Operations, Quality ... technologies and regulatory developments impacting healthcare cybersecurity.Deep understanding of GxP requirements, FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5… more
