- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit (SBU) Medical Affairs business strategy . This individual ... research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting to the Executive Director , RIIM , this role will be accountable to ensure a holistic Regulatory centric D ata M anagement ( R DM) capability ... with key c ross functional Leaders is critical. Th e Senior Director should have strong managerial experience, a high-level strategic understanding of regulatory… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global regulatory ... the development of regulatory strategies to ensure effective achievement of regulatory/ business objectives. The Executive Director will direct the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams (eg, Diagnostic Development Teams) and to external diagnostic business partners specifically:Use of CTA/CDx within clinical trialsDevice protocols and ... SAPsDevice non-significant/significant risk determinations (both submission to CDRH in a Q-sub process and in a streamlined fashion within protocol submission to CDER via the INDs), IDEsBiomarker strategies towards patient selection, patient stratification,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across the US Medical Teams, and in conjunction with the Daiichi Sankyo US Business , and the Daiichi Sankyo Global IEP network.- Lead the design and execution of ... discussions are informative, motivating, and translatable to the Daiichi Sankyo US Business division. This includes but is not limited to analyzing results… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe US Regional Director /Principal Scientist Medical Affairs (RDMA) is responsible for driving execution of the Value and Implementation (V&I) ... They are impactful members of regional cross-functional teams, including Global Medical Affairs (GMAT), US Commercial, Value Team, Policy and Market Access. They… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director / Principal Scientist, Regulatory Affairs Liaison , is responsible for the development and implementation of worldwide regulatory ... with more than one indication, formulation or have an external business partner.Coordinate the preparation, submission, and any follow-up contact with regulatory… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn this Sr. Principal Scientist/ Director position within Translational Oncology, this team member will provide leadership for aligned and integrated ... Teams (ADTs) and our diagnostic partners.-Position reports to Executive Director , CDx. Primary Responsibilities : Direct CDx/IVD development projects, including… more
- Merck & Co. (Rahway, NJ)
- …of new compounds, and the further study of marketed compounds.Support of business development assessments of external opportunitiesThe Senior Director May: ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities involving ... Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. The Executive Director will manage and oversee the entire cycle of late stage clinical… more
