- Merck & Co. (South San Francisco, CA)
- Job DescriptionHealth Systems Oncology Medical Affairs Director , US Medical Affairs - NorCal, NV, AZThe Health Systems Oncology Medical Affairs Director ... accurate information across the full oncology product portfolio, clinical science, and quality management in a balanced and credible manner consistent with the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …many stakeholders.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Require minimal direction to complete ... in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the Quality team… more
- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , Quality Assurance - Analytical,GMP has responsibility for the ... Provide expert QA review, collaboration, and direction for laboratory investigations.Apply Quality Risk Management for key processes and systems . Identify… more
- Tris Pharma (Monmouth Junction, NJ)
- …guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , AR&D serves as Deputy to ... Associate Director / Director , Analytical Research and DevelopmentMonmouth Junction,...and initiatives, including continuous improvement and streamlining of AR&D processes/ systems in productivity, efficiency and scientific quality … more
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical ... Job DescriptionJob Summary: -The Director of Device Technology Transfer is a key...proficiency in ISO 13485, ISO 14971, and other relevant quality management systems .Qualifications:Bachelor's degree in Mechanical Engineering,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPrincipal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director /Senior Director , the ... support of their assigned projects. Position Description- The Principal Scientist / Director responsibilities include but are not limited to:Serve as a Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team resources, issues, risks as well as achieving overall project level quality metrics. An ideal Associate Director , Program Management must have ... centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for effectively planning,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and proficient in creation of process maps preferredExperience working with Quality Management systems preferredExperience with requirements related to global ... Director , Development SOP Management Join a Legacy of...Authorship and Review Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP… more
- Aequor (Waltham, MA)
- …role - 3 days onsite, 2 days remote Position Summary: The IT Operations Director will oversee the operation of server systems , networking equipment, cloud ... Job description Job title - Director , IT Operations, and Infrastructure Location - Waltham, MA 02451 Permanent fulltime role Hybrid… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director of ERP Applications is responsible for overseeing and enhancing designated ... role encompasses overseeing design, configuration, testing, and deployment to ensure these systems operate efficiently and accurately. The primary goal is to meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for producing scientifically ... accurate, high- quality clinical regulatory documents while adhering to regulatory guidelines....strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director of Regulatory Writing is a key role responsible for producing ... scientifically accurate, high- quality clinical regulatory documents while adhering to regulatory guidelines....strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Associate Director , Automation Th is position will primarily be responsible for ensuring reliability and efficiency of site ... statistical techniques - Developing and implementing data analyses, data collection systems and other strategies that optimize statistical efficiency and quality… more
- Merck & Co. (Rahway, NJ)
- …the Design Authority.- They will ensure the smooth operation of our SAP systems with a mindset towards continuous improvement.- Their expertise in SAP System ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …available for presenting at senior leadership meetings.Ensure and lead the establishment of the Quality Systems for the Research Quality area, and that all ... research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders.Job Summary Deliver the development and implementation of informatics systems and programs to support the business functions of Daiichi Sankyo ... Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …curricula development experience desirable, including oversight and administration of validated electronic systems such as LMS or other quality management ... of N-3 leaders directly reporting to the VP of Quality , and in close collaboration with the QA Training...must have understanding of state of the art technology systems necessary to complete tasks and allow decision making.Responsibilities-… more
- Merck & Co. (Rahway, NJ)
- …Primary responsibility will be to maintain the Rahway based clinical equipment, systems and facilities in accordance with GMP and Safety requirements, as well ... and mentoring of engineers within the group. Provide engineering and quality engineering (QE) support, ensuring facilities, utilities and equipment are maintained… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Deliver the development and implementation of Research & Development (R&D) informatics systems and programs to support the business functions of Daiichi Sankyo (DS) ... Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services… more
- Eisai, Inc (Nutley, NJ)
- … quality , cost, and speed requirements.Strong technical knowledge of systems and applications within the applicable functional business area.Strong understanding ... productivity of business operations including mapping relationships between information systems components (ie, end users, business processes, applications, data, IT… more
