- Merck & Co. (Rahway, NJ)
- …sites with the collection and analysis of data for management review. Reports to - Director Regulatory Compliance , Device Quality and Regulatory Location ... Job DescriptionPosition Title - Director / Principal Scientist, Regulatory Compliance...Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance ... our pipeline and drive our strategic priorities.The Director , Principal Scientist - Regulatory Affairs Liaison... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. Key… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Tris Pharma (Monmouth Junction, NJ)
- …(FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , AR&D serves ... Associate Director / Director , Analytical Research and DevelopmentMonmouth Junction,...Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), Occupational Safety and Health Administration (OSHA), SOPs and regulatory… more
- Merck & Co. (Rahway, NJ)
- …modalities for clinical and/or commercial manufacturing would be idealExperience in regulatory compliance expectations across all phases of product development ... company is seeking a highly motivated candidate for the position of Director , Small Molecule Development within the Mixed Modalities, Sterile Product Development… more
- Merck & Co. (Millsboro, DE)
- … compliance with governmental regulations, and corporate/site policies including safety and biosafety.Utilize our systems such as Reliance, Atlas SRM, WorkDay, ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory … more
- Daiichi Sankyo, Inc. (Bernards, 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. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …top talent as needed to deliver on pipeline and innovation projects.Ensure training, safety , and compliance requirements are met and roles and responsibilities ... Job DescriptionThe Associate Director of Method Development & Testing is responsible...Development (AR&D), Design Controls & Risk Management (DCRM), Quality, Regulatory , and Quality Control (QC) facilities to ensure that… more
- Merck & Co. (Rahway, NJ)
- …written. Preferred Experience and Skills: Knowledge of Investigational drug regulatory requirementsAudit experience: safety , environmental, compliance ... Job DescriptionPosition Description: Associate Director , Process Engineer - Oral Solid Dosage, Clinical...progress of growth.Familiarity with US and EU GMP and Safety compliance regulations.Desire and willingness to learn,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …coach cross functional team staff in areas such as quality, compliance , safety , project planning, process development, technology development.Communicate ... Position SummaryThe Sr. Director of Technical Transfer is responsible for activities...packaging and labeling. This position will interface with Operations, Regulatory , Quality Assurance, Finance, R&D, Project Management and Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. Work with the business users… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... when necessary, through formal or informal presentations-Stays current in technology and regulatory changes both within and outside of our companies that may impact… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Computational Toxicology group within the Nonclinical Drug Safety (NDS) division at our company is actively seeking an enthusiastic AI/ML data ... at the forefront of AI/ML application and data science methodologies towards drug safety prediction.Note: This position is available in South San Francisco, CA or… more
- CHRISTUS Health (Tenneryville, TX)
- …programs as needed to comply with diverse healthcare laws or regulations . Monitors regulatory compliance of all healthcare practices to ensure no violations . ... service line and staff for a facility; ensures quality and full compliance with relevant policies and standards. Responsibilities: * Implementing and monitoring… more
- Merck & Co. (Rahway, NJ)
- …and accurate information and status updates to project sponsors and management.Champion compliance and safety ; promote a culture of diversity, inclusion, and ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May ... and dedicated colleagues while developing and expanding your career.The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and… more
- Merck & Co. (North Wales, PA)
- …talented and dedicated colleagues while developing and expanding your career.-- Director (Principal Scientist) has primary responsibility for the planning and ... span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including: study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... and hormone therapy products. Relationships The position reports to the Director , Strategic Pricing and Contracting. The individual will partner and work… more
