Principal Scientist
1 month ago
Insight Global is looking for an Associate Principal Scientist, Global Regulatory Affairs CMC to join the Global R&D organization of a large pharmaceutical company. This individual will be responsible for assessing change controls while reviewing technical documentation and scientific information. The Associate Principal Scientist will spend the majority of their time preparing regulatory CMC variations and supplements including technical writing of various CMC sections. This role will be cross-functional to R&D and other regulatory teams. The ideal candidate will have a strong background in API drug development and method development.
Required Skills & Experience:
- Bachelor's Degree in Scientific Field, PhD preferred
- 5+ years' experience in Drug Development
- 2+ years' experience with technical writing of CMC sections
- Strong communication skills
-
Principal Scientist
1 month ago
rahway, United States Insight Global Full timeInsight Global is looking for an Associate Principal Scientist, Global Regulatory Affairs CMC to join the Global R&D organization of a large pharmaceutical company. This individual will be responsible for assessing change controls while reviewing technical documentation and scientific information. The Associate Principal Scientist will spend the majority of...
-
Associate Principal Scientist
1 month ago
Rahway, United States Kelly Science, Engineering, Technology & Telecom Full timeThe Associate Principal Scientist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance. The Associate Principal Scientist is also responsible for the preparation and review of information required for development of regulatory CMC...
-
Associate Principal Scientist
1 month ago
rahway, United States Kelly Science, Engineering, Technology & Telecom Full timeThe Associate Principal Scientist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance. The Associate Principal Scientist is also responsible for the preparation and review of information required for development of regulatory CMC...
-
Rahway, New Jersey, United States Merck Sharp & Dohme (MSD) Full timeJob SummaryWe are seeking a highly skilled Senior Principal Scientist to join our team in Rahway, NJ. As a key member of our Oncology department, you will be responsible for planning and directing clinical research activities involving new or marketed Oncology medicines.Key ResponsibilitiesEvaluate pre-clinical and translational work to generate early...
-
Rahway, New Jersey, United States Merck Sharp & Dohme (MSD) Full timeJob DescriptionEarly Device Program Strategy and Due Diligence Principal ScientistJob SummaryThe Principal Scientist of Early Device Program Monitoring & Due Diligence will play a pivotal role in leading and coordinating diverse activities between various device and combination product development, discovery, and formulation development teams.Key...
-
Rahway, New Jersey, United States Merck Sharp & Dohme Full time**Job Summary**Merck Sharp & Dohme is seeking a highly skilled Senior Principal Scientist to lead clinical research activities in oncology medicine development. The ideal candidate will have a strong background in clinical medicine and biomedical research, with a proven track record of scientific scholarship and achievement.**Key Responsibilities**Evaluate...
-
Rahway, New Jersey, United States Merck Sharp & Dohme (MSD) Full timeJob DescriptionMerck Sharp & Dohme (MSD) is seeking a highly skilled Principal Scientist, Clinical Research, Breast Cancer to join our team. As a key member of our clinical research team, you will be responsible for planning and directing clinical research activities involving new or marketed Oncology medicines.Key Responsibilities:Develop and execute...
-
Rahway, New Jersey, United States Merck Sharp & Dohme (MSD) Full timeJob SummaryMerck Sharp & Dohme (MSD) is seeking a highly skilled Principal Scientist to lead clinical research activities in gynecological malignancies. The successful candidate will be responsible for planning and directing clinical trials, managing research teams, and collaborating with cross-functional groups to advance the development of new oncology...
-
Rahway, New Jersey, United States Merck Sharp & Dohme Full timeJob DescriptionOur company is seeking a highly skilled Principal Scientist to join our Biologics Process Research & Development (BPR&D) team. As a key member of our team, you will be responsible for designing and developing innovative purification processes for biologics in early- and late-stage development.ResponsibilitiesCollaborate with cross-functional...
-
Senior Regulatory CMC Biologics Scientist
4 weeks ago
Rahway, New Jersey, United States Merck Sharp & Dohme Full time**Job Summary**The Principal Scientist/Director is responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and guidance.**Key Responsibilities**Lead the preparation and submission of CMC sections...
-
Rahway, New Jersey, United States Merck Sharp & Dohme (MSD) Full timeJob SummaryWe are seeking a highly skilled Senior Principal Scientist to lead our clinical research efforts in hematology and lymphoma. As a key member of our team, you will be responsible for planning and directing clinical research activities, including study design, placement, monitoring, analysis, and regulatory reporting.Key Responsibilities:Evaluate...
-
Regulatory Compliance Director
4 weeks ago
Rahway, New Jersey, United States Merck Sharp & Dohme (MSD) Full timeJob DescriptionPosition Title: Director/ Principal Scientist, Regulatory ComplianceDepartment: Device Quality & RegulatoryBrief Description of Position:This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to ensure regulatory compliance...