- Tris Pharma (Monmouth Junction, NJ)
- …Executes studies and prepares technical protocols/reports in response to FDA Information Requests (IRs)/Complete Response Letters (CRLs)Cleans, maintains and ... calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and cGMPs; Cleans and organizes MV lab areasMonitors sample… more
- Merck & Co. (Rahway, NJ)
- …This research opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development ... our Research & Development Division - - in particular Discovery Pharmaceutical Sciences, Biologics Analytical Research and Development (BAR&D), Bioprocess research… more
- Merck & Co. (Rahway, NJ)
- …- This role ensures HVAC systems comply with regulatory standards (eg, FDA , cGMP), maintain optimal environmental conditions for product quality, and support ... and optimization of HVAC systems for both commercial office buildings and pharmaceutical laboratories at the Rahway, NJ Site.Develop, implement, and maintain HVAC… more
- Lundbeck (Fort Wayne, IN)
- …customers and patients including the full range of treatment options available. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of ... and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical… more
- Merck & Co. (Rahway, NJ)
- …expertise and knowledge of product and process development in the (bio) pharmaceutical and medical device industries to set tactical and strategic direction ... evaluations and control strategy.Deep and broad working knowledge of pharmaceutical vaccine/biologic/small molecule drug product and process development including… more
- Lundbeck (Fresno, CA)
- …payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of ... environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews systems and procedures.Ensure trending… more
- Lundbeck (Waco, TX)
- …payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Apply knowledge of pharmaceutical ... environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical… more
- Eisai, Inc (Nutley, NJ)
- …support, patient assistance programs, adherence support).Works to ensure Eisai's compliance with pharmaceutical laws and industry guidelines including ... Strong knowledge of FDA regulatory and fraud and abuse laws and/or pharmaceutical government price reporting laws. Ability to learn quickly and operate in a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and ... entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize… more
- Merck & Co. (Chicago, IL)
- …stakeholder management, communication, and networking skillsA thorough comprehension of FDA , OIG, HIPAA, and other ethical guidelines, laws, and regulations ... relevant to the pharmaceutical industry and its customersAbility to organize, prioritize, and...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Tris Pharma (Monmouth Junction, NJ)
- …FDA regulations, current Good Manufacturing Practices (cGMPs) and pharmaceutical supply chain dynamicsWorking knowledge of sustainable procurement practices, ... responsible for multiple facets of the Procurement function within a pharmaceutical manufacturing environment including, but not limited to, purchasing, sourcing,… more
- Merck & Co. (Rahway, NJ)
- …years with a degree in Chemical / Biochemical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related ... facilities.Experience authoring regulatory filings, and demonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC.- Strong understanding… more
- Merck & Co. (Chicago, IL)
- …dialogueExcellent stakeholder management, communication, and networking skillsThorough comprehension of FDA , OIG, HIPAA, and other ethical guidelines, laws, and ... regulations relevant to the pharmaceutical industry and its customersAbility to organize, prioritize, and...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Aequor (Hicksville, OH)
- …etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory ( FDA , DEA, OSHA) standards, and ... least two years experience in filling and packaging of pharmaceutical products. Basic knowledge of computer applications, including SHAPE...the use of a pallet jack. Knowledge of cGMP and SOP procedures for filling and packaging of pharmaceutical … more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …prior industry experience to optimize resource allocation, ensure regulatory compliance , and uphold rigorous scientific standards. Understanding best industry ... streams.Regulatory Oversight: Uphold the highest standards of quality and compliance with all regulatory bodies to include the USDA,... with all regulatory bodies to include the USDA, FDA , CDC, and other similar governmental regulators, as well… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …have been spent working in at least one of the following: At the FDA Supporting the pharmaceutical sector Product liability litigation Candidates with prior ... or enforcement litigation are preferred Additional experience within the healthcare/ pharmaceutical industry (including experience with FDA , advertising and… more
- Eisai, Inc (Nutley, NJ)
- …marketing, managed markets, sales/business analytics) preferred.Experience working with pharmaceutical manufacturer compliance & regulatory requirements ... and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong… more
- Eisai, Inc (Nutley, NJ)
- … compliance with regulatory and other ethical guidelines relevant to the pharmaceutical industry, and to ensure compliance with Eisai policies & ... and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP/Document Audits supports end-to-end audit activities per audit program of… more
