- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo. The candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical ... to author the Dose Preparation Instructions and address questions from the clinical sites. The candidate will optimize and continuously improve the Pharmacy Manual… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …point of contact between investigators and members of the Legend Biotech Medical Affairs and Clinical Development teams; Addressing AE management and education ... Science Liaison (South Central) as part of the Medical Affairs team based in TN, KY, AR, LA, or...Direct education for healthcare professionals treating oncology patients on clinical data, adverse event management, and mechanism of action… more
- Merck & Co. (North Wales, PA)
- …HTA submissions. The incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and ... resource utilization and costs, physician and patient satisfaction surveys, clinical and patient reported outcomes assessments, systematic reviews and meta-analyses,… 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
- Merck & Co. (Rahway, NJ)
- …Teams and the regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Key ... Job DescriptionThe Director/ Principal Scientist, Regulatory Affairs Liaison , is responsible for the development and implementation of worldwide regulatory strategy… more
- Merck & Co. (Rahway, NJ)
- …US lead will work closely with cross-functional stakeholders, including US Medical Affairs (USMA) Leadership, Global Medical Scientific Affairs (GMSA) TAs, US ... to drive medical modernization efforts and transformational change within US medical affairs , fostering a culture of continuous improvement to achieve long term… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the ... strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit (SBU) Medical… more
- Merck & Co. (Rahway, NJ)
- …work closely with the PaCES lead to collaborate with individuals from Clinical Research, Regulatory Affairs , Biostatistics, Outcomes Research, and Operations to ... lead, the Senior Scientist has responsibility for coordinating global Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport and working relationships with… more
- Tris Pharma (Monmouth Junction, NJ)
- …requirementsProvides medical writing guidance and supports cross-functional teams (ie, clinical development, regulatory affairs , biostatistics, external vendors, ... advanced medical writing expertise and leadership in the preparation of clinical and regulatory documents. Collaborating closely with cross-functional teams to… more
