- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... medical topics, and supports PV Operations ' medical review function. This position supports a senior...board eligibility preferred Experience Qualifications1 or More Years of clinical experience preferred Daiichi Sankyo, Inc. is an equal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (Rahway, NJ)
- …of our Company's drug product pipeline.- The FLEx Sterile Process Engineer at the Associate Director level serves as a technical subject matter expert in process ... Jersey and reports to the FLEx Sterile Process Engineering Lead in Pharmaceutical Operations & Clinical Supply.- Primary Responsibilities: Serve as a technical… more
- Merck & Co. (Rahway, NJ)
- … experience and a strong understanding of engineering fundamentals. The MACS Operations Specialist position will report to the Director , Engineering and ... infrastructure.- Responsibilities of the Operations Specialist include the following:The Operations Specialist role at the Associate Specialist level will… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations , Non- clinical , Clinical , and other functional ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …experience partnering for Pharmaceutical development / CMC with Quality, Regulatory, Operations , Non- clinical , Clinical , and other functional areasExperience ... 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. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations , Non- clinical , Clinical , and other functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in support of Phase I-III clinical studies. Partner with Project Management, Clinical Operations and other functional groups to ensure budgets are always ... for the development and control of functional budget in support of global operations of RD unit. Partner with global function leaders to ensure budgets are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US, EU, Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, ... Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads ... and Regulatory Liaisons to ensure successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globallyFor late-stage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director , Precision Medicine Clinical Laboratory Operations will be responsible for Clinical Laboratory Project & Program management ... for various therapeutic areas working closely with Director , Precision Medicine Clinical Laboratory ...early and late-stage programs within our pipeline. **As an Associate Director , a typical day may include… more
- IQVIA (Linden, NJ)
- Job Overview Direct a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and ... issues and resolving problems. * Direct the hiring and selection process for clinical staff by participating in the interviewing process. Ensure that new employees… more
- Merck (Rahway, NJ)
- …team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of ... **Job Description** **Position Description:** ** Associate Director , Process Engineer - Oral...+ Audit experience: safety, environmental, compliance/quality + Understanding of Clinical Supply Chain Operations + Experience with… more
- Merck (Rahway, NJ)
- …our company, a premier research-intensive biopharmaceutical company. We are seeking an Associate Director , Clinical Systems Implementation to manage ... the successful implementation and use of multiple applications. + Represent Global Clinical Trial Operations (GCTO) (business) in application related decisions… more
- Merck (Rahway, NJ)
- **Job Description** The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full ... company Research Laboratories (Research and Development Division) portfolio of clinical trials. GCS is accountable for the planning, sourcing, labeling, packaging… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Bristol Myers Squibb (Madison, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , WW Cell Therapy Medical, Operations and Product Science will ... report to the Executive Director CT Medical Franchise. He/she will expected to attend...as therapeutic area expert in Cell Therapy and provide clinical /scientific leadership and support for approved CAR T products… more
- Bristol Myers Squibb (Summit, NJ)
- …motivated and experienced Business Operations Leader to join our team. The Associate Director of Product Development (PD) Operations , reporting into the ... business questions across the enterprise. In this role, the Associate Director of PD Operations ...unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... medical topics, and supports PV Operations ' medical review function. This position supports a senior...preferred Experience Qualifications + 1 or More Years of clinical experience preferred _Daiichi Sankyo, Inc. is an equal… more
