- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …internal and external customers on GxP related regulations / guidelines (eg, FDA , EU, ICH) and company procedures and policies. Competencies:Professional or other ... Companion Diagnostic productsProven experience with Health Authority Inspections, (eg, FDA , HPFB, MHRA and other European regulatory agenciesInternational experience… 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
- 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 ... and dissolution apparatusWorking knowledge of cGMP, Food and Drug Administration ( FDA ), Drug Enforcement Administration (DEA) and Occupational Safety and Health… 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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 work effectively in a constantly changing environmentStrong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Teams, OneNote)Familiarity with… more
- Lundbeck (Fresno, CA)
- …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+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must… more
