- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma.Legend Biotech is seeking Global Applied Statistics & Analytics Expert as part of the Global MSAT team based Remotely. Role OverviewThis ... therapy SMEs and the vector programsProvides advanced statistical analyses and development of simulation models (ie. predictive of risks to study failure)Expertise… more
- Merck & Co. (Upper Gwynedd, PA)
- …Oncology medicines. Our Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire ... cycle of clinical development , including study design, placement, monitoring, analysis, regulatory reporting,...our company's and Competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas… more
- Merck & Co. (Lower Gwynedd, PA)
- …a Senior Scientist for the Serology Lab team within the Late Development (AdVAnce) Vaccines bioanalytical group located at our Company's new state-of-the-art AdVAnce ... to contribute with limited supervision to all aspects of assay development on robotic platforms, technology transfer, validation, troubleshooting, and phase III… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2) ... trials, clinical sciences, medical monitoring, target product profile (TPP) development , due diligence projects, and clinical-regulatory compliance. ResponsibilitiesEssential Duties… more
- Merck & Co. (North Wales, PA)
- …positioning you for future leadership roles.Responsibilities: Lead brand and HCC/AHP strategy development and serve as subject matter expert for market ... for HIV with the potential to add other assets which are in early development . The Director, Product Marketing Owner - HCC/AHP Team Lead will play a critical… more
- Genmab (NJ)
- …love to have you join us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication ... as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and main… more
- Merck & Co. (Rahway, NJ)
- …the individual will be responsible for leading CMC project teams and the formulation development of new chemical entities through a matrix team from initial first in ... within the organization. - - Primary Responsibilities: - Lead development of new, innovative approaches for product development...drug delivery technologies - Is a recognized subject matter expert in at least one area of drug delivery… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... communication/publication components of overall medical operating plan. Provide strategic development , planning, implementation and oversight of Phase IV clinical… more
- Merck & Co. (Rahway, NJ)
- …health. In this role, the individual will be responsible for leading the formulation development of new chemical entities as part of a matrix team from initial first ... process robustness assessment. - - Primary Responsibilities: - Lead development of new, innovative approaches for product development...across functional areas and is a recognized subject matter expert in at least one area of drug delivery… more
- Merck & Co. (North Wales, PA)
- …activities involving investigational compounds in Immunology. With a focus on late-stage development , the Senior Clinical Director will manage the entire cycle of ... clinical development , including determination of appropriate disease indications to pursue...our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description The Chemical Engineering Research & Development department (CERD), part of the Process Research and Development ... and technically focused individual to serve as crystallization subject matter expert . The incumbent will develop isolation processes that deliver desired solid-state… more
- Merck & Co. (Rahway, NJ)
- …Rahway, NJ team as a Scientist (R2) in Biologics Analytical Research & Development (AR&D) GMP Operations, to support separations methods (eg HPLC, UPLC, CE, iCIEF). ... incumbent will collaborate closely with various stakeholders, including Analytical Development , External Capabilities, Quality Assurance, Technical Operations, and CMC… more
- Merck & Co. (Rahway, NJ)
- …a highly experienced and skilled Distinguished Scientist to join our Device Development & Technology (DD&T) organization to serve as a senior technical subject ... matter- expert and advisor for our Autoinjector platform. This role's...and accountability will encompass the entire lifecycle from early development through lifecycle management, providing critical technical strategic oversight… more
- Merck & Co. (Rahway, NJ)
- …Quality Assurance oversight for computer system validation matters within the Global Development Quality organization and for the Company's Research & Development ... thereby promoting permanent inspection readiness.Develop and maintain a subject matter expert level of understanding for the our Company Policies, Procedures and… more
- Merck & Co. (Rahway, NJ)
- …be a subject matter expert in the area of microbial fermentation process development and is expected to lead and drive innovation in this area to enhance ... an Associate Principal Scientist with experience in fermentation engineering and process development . Our team is part of the Continuous & Expression Technologies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regions. This individual is responsible for performance of the function and the development of group members and also monitors trends in functional performance via ... sufficient understanding of regulations and GCP requirements for drug development , advanced knowledge of Electronic Data Capture/related applications and industry… more
- CoxHealth (Lake Spring, MO)
- …Rapid Response calls, follow-up visits, EIT data collection, entry and analysis, development of EIT practice guidelines, evaluation of patient codes and informal ... STEMI and In-House Trauma. * Being regarded as a resource and subject matter expert for staff on patient care issues. * Providing consultative assessments to help… more
- Merck & Co. (Cincinnati, OH)
- …a credentialed (ie, MD, PhD, DNP, or PharmD) therapeutic and disease area expert who engages in both scientific exchange and research support, when requested, with ... Independent Investigator Study Programs as prioritized and requested by Research and Development (R&D) leadership. -Virology RMSDs reports to the Regional RMSD Team… more
- Merck & Co. (Rahway, NJ)
- …Training Materials: Create and maintain training content aligned with Global Clinical Development standards and Good Clinical Practices (GCPs) and End to End ... and regulatory requirements. - Defines and contributes to the development of training strategies for GCTO Regions - Deliver...such as local or country-level training or subject matter expert (SME) training. - Preferred Experience: 1 year CRM… more
- Merck & Co. (Rahway, NJ)
- …our company. This role leads a center of excellence team within Device Development & Technology (DD&T) engaged across the entire product lifecycle-from early ... development through commercialization and post-market activities-ensuring integration of HF...product lifecycle activities.Serve as a trusted HF subject matter expert via engagements with Health Authorities and Industry Trade… more
