- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... are in compliance with local and federal regulations (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards Maintains proficient understanding… more
- Merck & Co. (Rahway, NJ)
- …areaKnowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors ... guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.Proven track record of applying analytical skills in product design, development, and evaluationSelf-motivated and work independentlyProven ability to work with team members of diverse skill sets… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... understanding of local/federal laws and applicable regulations applicable (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards (ie. Good… more
- Lundbeck (Fort Wayne, IN)
- …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… more
- Merck & Co. (Rahway, NJ)
- …PreBLA meeting preparation, study data standards plan, preparing questions for FDA e-data mailboxes (CBER/CDER), attendance at meetings with regulatory agencies ( ... FDA , EMA, PMDA),Guiding project teams preparing submission deliverables including use of Pinnacle 21 Enterprise,Up-versioning activities to specific versions of… more
- Merck & Co. (Rahway, NJ)
- …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.-Additionally possess extensive knowledge in traditional worldwide pharmaceutical regulations including but not limited to 21CFR210, 211, 600-680, ICH Q8/9/10, Directive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to prepare for tomorrowTrack record of successfully leading audits and inspections ( FDA , EMA, etc.)An ability to build strong partnerships and effectively integrate ... engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and other global regulatory requirements for pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- …(Research & Development) by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for ... Team to help our company build solid and trustworthy relationships with FDA and global health authorities.- Pro-actively influences and manages relations with … more
- AUROBINDO (Durham, NC)
- …documents to broker to expedite receipt of incoming product through customs and the FDA . The position is also required to work closely with Quality Control to make ... of each formulation for each line.Communicating with brokers for timely FDA release of materials.Measuring and reporting effectiveness of the department… more
- Twist BioScience (South San Francisco, CA)
- …Ensure our custom MES solutions comply with GxP regulations (eg, cGMP, GLP), FDA 21 CFR Part 11, Eudralex Annex 11, and internal quality standards. Oversee ... (eg, SQL Server, Oracle, PostgreSQL).Extensive knowledge of GxP regulations (especially cGMP), FDA 21 CFR Part 11, and Eudralex Annex 11, with practical experience… more
- Aequor (Hicksville, OH)
- …cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, 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 Departmental, Plant, and Corporate quality and… more
- Aequor (Hicksville, OH)
- …cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, 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 Departmental, Plant, and Corporate quality and… more
- Aequor (Hicksville, OH)
- …cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, 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 Departmental, Plant, and Corporate quality and… more
- Aequor (Athens, GA)
- …environment. Preferably experience with Documentum, MS Teams, MS Sharepoint. 21CFR Part 11, GLP ( FDA and EPA), GMP ( FDA and EU), VICH Internal BI policies on ... Records Management, Training Management, Information Protection. The individual must be very detail oriented and able to follow precise instructions. Understanding of typical pharmaceutical and/or biological development processes and documentation is strongly… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and this position acts as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position ... documents where necessary with supervision.Health Authority Interactions: Leads US FDA /EU EMA interactions with support from higher-level manager.Regulatory Knowledge:… more
- Eisai, Inc (Nutley, NJ)
- …for US. Responsible for oversight and strategic planning of the meetings with FDA , EMA, PMDA. Provide strategic support for meetings with other Health Authorities ... the CDE. Actively participates in Health Authority GCP inspections (eg, FDA , EMA, PMDA) including responding to observations and development of corrective actions.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and… more
- Genmab (NJ)
- …in biologics, targeted therapies, and companion diagnostics preferredExperience working with FDA , EMA, and ICH guidance for drug development pertaining to ... statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing… more
- Genmab (NJ)
- …knowledge and adherence to corporate compliance policiesCurrent working knowledge of FDA , OIG, ICH, GCP, PhRMA Code, HIPAA and other compliance regulations ... and guidelines relevant to industry interactions with healthcare professionalsDemonstrated technical acumen including MS Office skills, ability to adopt and leverage multiple business applicationsFor US based candidates, the proposed salary band for this… more
