- Novo Nordisk Inc. (West Lebanon, IN)
- …activities Ensures change control activities for systems are completed in a manner in compliance with FDA , EU and NN regulations Responsible for the verification ... processes are verified and validated in a compliant manner in accordance with FDA , EU and NN requirements Actively participate on cross functional teams to determine… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in compliance with local and federal regulations (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards Maintains proficient understanding ... provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews systems and procedures.Ensure trending ... against these metrics consistently. Provide inspection management support regarding compliance concerns identified during internal systems audits, remediations implemented… 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 ... thereby ensuring highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …more years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA , EMA) (Required)2 or more years ... on a consistent basis and identifying areas of potential non- compliance or operational risks.Responsibilities:Maintain regulatory procedural documentation, in line… 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 ... the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating… more
- Merck & Co. (Rahway, NJ)
- …Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.Lead ... areaKnowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors… 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...success in the assurance of deliverable quality and process compliance .Excels in technical writing, able to convert complex ideas… 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 ... calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and cGMPs; Cleans and organizes MV lab areasMonitors sample… more
- Lundbeck (Fort Wayne, IN)
- …patients including the full range of treatment options available. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and regulatory ... environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply… 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 ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… 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 ... to prepare for tomorrowTrack record of successfully leading audits and inspections ( FDA , EMA, etc.)An ability to build strong partnerships and effectively integrate… more
- Twist BioScience (South San Francisco, CA)
- …technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the full Software Development ... and data visualization capabilities to support operational decision-making and quality reviews. Compliance & Validation: Ensure our custom MES solutions comply with… 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 ... cleaning tasks on machine during or after machine operation. Maintains compliance with SOPs, good documentation practices (GDP), training requirements, Company and… more
- Tris Pharma (Monmouth Junction, NJ)
- …supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory agency ... procurement policies and procedures throughout the organization. Ensures compliance with all current GxPs, Food and Drug Administration ( FDA ), Drug Enforcement… 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 ... Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals. Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be… 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 ... Departmental, Plant, and Corporate quality and safety Behaviors. Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee must be trained under OSHA's… more
- Repligen (Waltham, MA)
- …growing Supplier Quality team. You will a key role in ensuring the quality, compliance , and performance of Repligen's global supplier base. This is an opportunity to ... Notifications (SCNs)Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams… 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 ... of the value chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to… more
- Genmab (NJ)
- …constantly changing environmentStrong compliance 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… more
