- 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
- 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
- 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
- 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
- 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
- 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)
- …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
- 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
- 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
- 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
- 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
- Eisai, Inc (Nutley, NJ)
- …support, patient assistance programs, adherence support).Works to ensure Eisai's compliance with pharmaceutical laws and industry guidelines including the ... Act, federal and state pricing-related laws and regulations, PhRMA Code and FDA regulatory guidelines.Serves as the legal representative for market access materials… 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)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP/Document Audits supports end-to-end audit activities per audit program of ... provide inspection management support and follow-up activities post inspection regarding compliance commitments are fulfilled on time and that evidence is… more
- Eisai, Inc (Boston, MA)
- …responsibility of leading demand generation in a manner consistent with the FDA -approved indication to meet or exceed sales objectives. This will be accomplished ... conveying complex clinical information to customers and key stakeholders regarding FDA -approved indications of this novel therapy. The individual will implement and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …limited to Medical, Regulatory, Marketing, Sales, Commercial Operations, and Ethics, Compliance & Privacy. May interact with government agencies, law firms, trade ... interactions with health care providers, patients, and payors in compliance with fraud and abuse laws such as the...in at least one of the following: At the FDA Supporting the pharmaceutical sector Product liability litigation Candidates… 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
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