- Merck & Co. (Rahway, NJ)
- …Point, PA / Rahway, NJ is seeking a curious and collaborative Director to support our rapidly expanding cardiology respiratory, metabolism and ophthalmology ... pipeline.As a Director , you will serve as an expert QP2 representative...teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for cardiac, respiratory,… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director , Global Market Access, Immunology T he Director , Global Market Access, Immunology will play a leadership role in ... strategy for assets within our Immunology portfolio. In this role, the Director will lead the development and execution of global market access strategy,… more
- Merck & Co. (Rahway, NJ)
- …Our company's oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire cycle ... placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre- clinical and… more
- Merck & Co. (Rahway, NJ)
- …Our company's oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of ... design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible for:-Evaluating pre- clinical and… more
- Merck & Co. (Rahway, NJ)
- …understanding of engineering fundamentals. The Process Supervisor position will report to the Associate Director , MACS Operations and will be a member of the EF ... process supervisor role at the Specialist level will serve as an operations team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This… more
- Merck & Co. (Rahway, NJ)
- …(Non-Sterile) team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor ... is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This team works with… more
- Merck & Co. (Rahway, NJ)
- …project management responsibility. The Specialist -Engineering position will report to the Associate Director , Engineering and will be a member of the EF Team at the ... interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and exploring new technologies. -… more
- Merck & Co. (Rahway, NJ)
- …You will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities will include:-Driving our company's Pipeline:-Leading ... process development.Defining and implementing end-to-end analytical control strategies for clinical supplies under good manufacturing practices (including method development… more
- Merck & Co. (Rahway, NJ)
- …Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving ... of release, characterization, and stability assays for testing of clinical trial material and in support of product and...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …limited to Group Heads in Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT members. He/she will also serve as the ... in one or several programs. Partner and collaborate with RD leaders in Clinical Operations , Biostatistics and Data Management, Regulatory Affairs, and other RD… 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
- 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)
- …stakeholders including members of Global Companion Diagnostics, Translational Sciences, Global Clinical Operations , Biostats and Data Management and Clinical ... IVD Development Process, with direct experience with Companion Diagnostics implementation in clinical trials and companion diagnostics operations is a plusSolid… more
- Tris Pharma (Monmouth Junction, NJ)
- …improvement of Good Clinical Practices (GCPs). The role partners with Clinical Development, Clinical Operations , Medical Affairs and R&D Quality ... Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director /Senior Director , Clinical Quality Assurance. This is a hybrid… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cross-functionally. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position ... as DM SME in internal audits and/or regulatory on-site inspectionsKnowledge of clinical trial operations , clinical trial data flow, pharmacovigilance,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support ... other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution plans across and effective alignment within (eg with translational research, clinical operations , clinical development, medical affairs CSPV and ... A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Director , Global Oncology Medical Affairs, Evidence Generation role is responsible for ... using trackers and tools generated by Global Oncology Medical Affairs Study Operations partners and propose mitigation plans for delayed activities. Ensure that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThe Senior Director , Global Oncology Medical Affairs, Evidence Generation role is responsible ... using trackers and tools generated by Global Oncology Medical Affairs Study Operations partners and propose mitigation plans for delayed activities. Ensure that… more
