- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD ... 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)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... study reports, investigator brochures, regulatory briefing documents, and clinical and clinical pharmacology sections...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology , Clinical Safety and Pharmacovigilance, ... Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. The Tech Lead must have the ability to develop a strong, positive strategic business… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director , Clinical Pharmacology - Virology** ... Jersey_** **POSITION OVERVIEW:** With considerable independence, you will typically lead clinical pharmacology studies of increasing complexity in Virology… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD ... 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. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a key role responsible for ... study reports, investigator brochures, regulatory briefing documents, and clinical and clinical pharmacology sections...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology , Clinical Safety and Pharmacovigilance, ... Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. The Tech Lead must have the ability to develop a strong, positive strategic business… more
