- Merck & Co. (Rahway, NJ)
- …: Education Minimum Requirement: Bachelor's Degree +9 years of pharmaceutical, clinical drug development, project management , and/or-medical field ... clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct...experienceOR Master's Degree +6 year of pharmaceutical, clinical drug development, project management ,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description:- Director of Clinical Procurement for FSPThis role leads the global procurement category for Functional Service Provision (FSP) ... of procurement professionals who have direct responsibility for sourcing, contracting and project delivery.Process - Deliver sourcing management , supplier value … more
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and may collaborate with team on CAPAs, including CAPA responses and approvals Project Management :Collaborates with the PSL(s) to proactively plan and prioritize ... to efficiently evaluate safety is desirable.Microsoft Word, Excel, PowerPoint skills, and Project management skillsAble to work independently with minimal direct… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and scientific input to Marketing/Market Access departments as needed Project management liaison: Assist in developing clinical program time lines, budgets, ... drug development phases, statistical research methodology experience) Leadership skills; project management skills; effective communication and presentation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of ... Quality team based in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management ...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the ... 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)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of ... regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services Project Management and Operational Management .Develop a strong, ... Leads and the business users to define user information needs.Provide informatics project management , SDLC Quality Model expertise, and computer system… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …This position will interface with Operations, Regulatory, Quality Assurance, Finance, R&D, Project Management and Quality Control departments to complete the ... Position SummaryThe Sr. Director of Technical Transfer is responsible for activities...development, scale-up, process optimization, customer technology transfer activities with project management assistance.Provide SME information on the… more
- Merck & Co. (Rahway, NJ)
- …GDMS (eg cross-divisional projects, cross-industry initiatives, etc.)- May support any other project or perform any other data management or drug surveillance ... BS degree in relevant discipline.-Knowledge and Skills:--Minimum 6 years' experience in Clinical Data Management or Pharmacovigilance as appropriate to business… more
- Merck & Co. (Rahway, NJ)
- …a senior levelExcellent interpersonal communication (written and verbal)Results-oriented project management skillsPreferred Experience and Skills:Impactful ... Job DescriptionThe Executive Director , Scientific Affairs (EDSA) maximizes meaningful bi-directional scientific exchange with the worldwide clinical and academic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ability to combine attention to detail with big picture perspective preferredStrong project management skills, experience leading projects/teams and ability to ... Director , Development SOP Management Join a...functional cohesiveness across SOPs and related documents related to clinical trial execution.Responsibilities:Development SOP Landscape Develop and maintain overview… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead. This position leads labeling meetings for preparation of responses to comments… more
- Merck & Co. (Rahway, NJ)
- …company is seeking a highly motivated candidate for the position of Director , Small Molecule Development within the Mixed Modalities, Sterile Product Development ... for parenteral drug products within the small molecule and synthetic modality pipeline.The Director will report to the Executive Director of Sterile Product… more
- Merck & Co. (Rahway, NJ)
- …Experience & Skills:- Outstanding communication, critical thinking, and leadership skills. Project management experience including resource management , ... Job Description Job Description: Director (M3), Analytical External Capabilities, Validation & Compliance...& Development (AR&D) department within the Development Sciences and Clinical Supplies (DSCS) organization and lead a group of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and control of Clinical Project Budget in support of Phase I-III clinical studies. Partner with Project Management , Clinical Operations and other ... process. Coordination with all functional areas impacted including Legal, Procurement, Project Management and Commercial or Corporate Finance, Operations.… more
- Merck & Co. (Rahway, NJ)
- …with cross-functional teams including AR&D, DCRM, Quality, Regulatory, and QC facilities.Strong project management skills and the ability to prioritize and ... and execution to internal and external GMP testing nodes in support of clinical and PPQ supplies. Additionally, the Associate Director leads, manages, and… more
- Merck & Co. (Rahway, NJ)
- …updates.Supports device sites with the collection and analysis of data for management review. Reports to - Director Regulatory Compliance, Device Quality ... Job DescriptionPosition Title - Director / Principal Scientist, Regulatory Compliance Department - Device...Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position… more
- Merck & Co. (Rahway, NJ)
- … trial material and in support of product and process development. Project management skills Established scientific or regulatory reputation supported by ... scientific rigor. Proactively identifying and escalating operational risks. Partnering with director -level management to develop and execute operational and… more
