- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director/ Principal Scientist , Regulatory Affairs Liaison , is responsible for the development and implementation of worldwide regulatory ... Affairs and Clinical Safety (GRACS) and external to GRACS.Key functions:Reports to Senior Principal Scientist ( Senior Director) and/or Distinguished … more
- Merck & Co. (Rahway, NJ)
- …bioprocessing to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist .BPR&D within Research Laboratories is committed to rapidly ... publish and engage with the scientific community to influence the field.As a Senior Principal Scientist , you will drive various strategic initiatives and… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe Senior Director ( Senior Principal Scientist ) has primary responsibility for the planning and directing clinical research activities ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director may… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Function: The Senior Scientist position is a laboratory-based scientific role in a fast-paced, multidisciplinary team environment. The role ... The individual will have a deep understanding of the regulatory and business environment and needs related to API...and/or ICP-MS. Working knowledge of CMC filing requirements and regulatory guidance's ( eg , ICH) for API Demonstration… more
- Aequor (Thousand Oaks, CA)
- …skills: Knowledge of case management and medical review SOPs and regulatory requirements for Pharmacovigilance Clinical knowledge of therapeutic area patient ... populations and drug class Proficiency in technical safety systems including the Safety database and medical coding Knowledge of safety data capture in clinical trials and in the post marketing environments Knowledge of clinical trials and drug development… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Principal Scientist .BPR&D within Research Laboratories is on a mission to rapidly deliver diverse ... and engage with the scientific community to influence the field.As a Principal Scientist you will have the opportunity to influence the future direction of Upstream… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionIn this Sr. Principal Scientist /Director position within Translational Oncology, this team member will provide leadership for aligned and integrated ... where relevant, DP) development teams for various assets/biomarkers (including Regulatory , Commercial, Business Development, Project Management, Operations, Clinical Development,… more
- Merck & Co. (North Wales, PA)
- …the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. Design and maintain statistical ... datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. Act as key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, a Principal Scientist /Director, has primary responsibility for developing value evidence ... and develops value evidence strategies for cross tumor activities. Obtains senior management approval of evidence generation plans. Provides outcomes research… more
