- Merck & Co. (Rahway, NJ)
- …The Regulatory Planning and Publishing (RPP) Organization within Global Regulatory and Clinical Safety - Operations Process and Systems-(GRACS-OPS) is ... planning, and management of timely, compliant, and high quality regulatory and safety submissions. -- Working closely with the Digital Innovation &… more
- Merck & Co. (Rahway, NJ)
- …Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary ... Job DescriptionOur Regulatory Affairs team bring new medical advancements to...communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the… more
- Merck & Co. (Rahway, NJ)
- …General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's Research ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- UT Health Tyler (Tyler, TX)
- …Provides education to focus areas regarding Quality Monitoring and Improvement, Regulatory Compliance, Patient Safety , Risk Management, Medical Staff Services ... advancing healthcare, together. POSITION SUMMARY The position of Quality and Patient Safety Director at UTHET is accountable for assisting the organization to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to clinical studies, post-marketing surveillance, signal detection and management, important safety topics, and regulatory submissions. This individual will ... evaluation related documents/deliverables on time.- Coordinate and participate actively in safety -related regulatory interactions (eg, regulatory meetings,… more
- Aequor (Thousand Oaks, CA)
- …systems and laboratory log books. Preferred Qualifications Ability to adhere to regulatory requirements, written procedures and safety guidelines? Ability to ... and adaptable to changing priorities and requirements? Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance?… more
- Eisai, Inc (Nutley, NJ)
- …business processes. Responsible for approval of medical and scientific content of Regulatory , Safety , Scientific Affairs, Medical Affairs and Commercial outputs ... conduct of clinical studies in relevant therapeutic areaKnowledge of regulatory guidance regarding marketing/sales promotional materialsStrong overall written and… more
- Eisai, Inc (Nutley, NJ)
- …business processes. Responsible for approval of medical and scientific content of Regulatory , Safety , Scientific Affairs, Medical Affairs and Commercial outputs ... conduct of clinical studies in relevant therapeutic area.Knowledge of regulatory guidance regarding marketing/sales promotional materialsStrong overall written and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety , Data Management, and Non-clinical ... of the written deliverables that support the clinical development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer… more
- Eisai, Inc (Nutley, NJ)
- …and value to support medical development, additional (post approval) regulatory and safety needs.Ensure communication/publication strategies for given ... datasets.Previous RWE experience in clinical/medical development, and interactions with regulatory authorities is desirable.Proven experience with launch of products… more
- Merck & Co. (Rahway, NJ)
- …with regulatory agencies.Demonstrated skills in complying with one or more regulatory programs: RCRA, Title V, Process Safety Management (PSM), Industrial ... Job DescriptionPosition Description: Director Safety & Environment The Rahway Environmental, Health, and Safety (EHS) Director is responsible for development and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Merck & Co. (North Wales, PA)
- …and Global Clinical Development (GCD) leaders, and internal stakeholders (eg Global Regulatory Affairs and Clinical Safety [GRACS], Global Clinical Supplies ... needed, collaborate with other QCI roles on quality issues and regulatory inspectionsRepresents GCD/GCTO/Research Division on special projects that may be… more
- Merck & Co. (North Wales, PA)
- …with internal and external stakeholders including Statistics, Clinical Research, Regulatory , Observational Research, Clinical Safety and PK/PD Modeling ... internal stakeholder groups including the Outcomes Research and Clinical Safety organizations.Lead and actively contribute to departmental strategic initiative… more
- Lincare Inc. (Farmingdale, NJ)
- …and relevant respiratory therapy conceptsFollows applicable policies and procedures of the Safety & Regulatory Manual regarding General Safety , OSHA ... (includes the proper use of Personal Protective Equipment), DOT (driving safety ), FDA, and Emergency PlanningRepresents the company through professional personal… more
- Sazerac Company (Louisville, KY)
- …including package changes.Works with site leadership to ensure compliance with safety , regulatory and environmental requirements for all assigned projects.Meet ... culture of employee engagement to drive improvements. Job Description/Responsibilities: Design safety into all new bottling installations. Develop SOPs for all… more
- Merck & Co. (Durham, NC)
- …activities while ensuring product quality and optimized maintenance processes, regulatory compliance, employee and environmental safety , integration of ... to the patients around the world with our core principle of Safety First and Quality Always.The Associate Director, Engineering/Maintenance will support a new… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to prioritize investigations based on potential impact on product quality, patient safety , and regulatory compliance. Address recurring deviations and health ... authorities' observations as a priority. CAPA Management: Oversee the timely implementation and effectiveness assessment of corrective and preventive actions identified during investigations. Ensure prevention of recurrence and improvement of batch disposition… more
- Merck & Co. (Rahway, NJ)
- …that all team activities are completed with the highest regard for safety , quality and regulatory compliance.Qualifications: Education: Degree in engineering or ... pilot plant scale-up and activities to support technology transfer and regulatory filings. The incumbent will be responsible for the performance and… more
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Senior Manager Safety Regulatory