- Catalent (New York, NY)
- Account Director , Biologics Drug Substance Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative ... Industry experience with a technical sales focus, or 5+ biologics drug substance operations experience and 1 or more years of technical sales or commercial … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team ... of 7 years of relevant experience. required Experience Qualifications Experience in clinical operations methods and processes in industry setting. required… more
- Merck & Co. (Rahway, NJ)
- …and innovative solutions that enable new capabilities and technologies. As the Clinical Supply Delivery Lead for our research organization, you will be responsible ... for delivering SAP solutions to our Research Organizations' Global Clinical and Ancillary Supply-user community. You will p articipate in interviews with our… more
- Merck & Co. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary… more
- Merck & Co. (Rahway, NJ)
- …monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre- clinical ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or several programs.Partner and collaborate with RD leaders in Clinical Operations , Biostatistics and Data Management, Regulatory Affairs, and other RD ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical ... Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT membersHe/she will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with… more
- Merck & Co. (Rahway, NJ)
- …sites. The team works closely with leaders and scientists within Discovery, Pre- clinical Development, Manufacturing, Quality Assurance and Regulatory groups and ... Job DescriptionThe Executive Director of Materials and Biophysical Characterization is responsible...for IND/CTA/NDA filings. Addresses measurement and quality-related inquiries from regulatory agencies to support clinical trial and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, ... serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA...Inc. related to assigned products/project areas such as the clinical supplies organization, Reg Operations , Medical Affairs… more
- Merck & Co. (Rahway, NJ)
- … clinical development and successful commercial implementation.The Global Marketing Director , InLine Dx, Precision Medicine will be responsible for the ... across both diagnostics and pharma?Then you could be our new Global Marketing Director , InLine Dx, Precision Medicine. The position: -We are currently recruiting for… more
- Merck & Co. (Rahway, NJ)
- …understanding of the regulatory environment, and a-vision to influence the regulatory environment.Nature and Scope of Position:The Director reports to the ... chemical and biochemical promcesses, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry… more
- Insmed Incorporated (Bridgewater, NJ)
- …to, the following: Provides medical/scientific input and advice by working closely with Clinical Scientists and Clinical Operations personnel on clinical ... amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program level… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Merck & Co. (Rahway, NJ)
- …across both diagnostics and pharma? Then you could be our new Global Marketing Director of Digital Diagnostics! - The Position: We are currently recruiting for a ... Marketing Director , Digital Pathology within our Precision Medicine, Global Oncology...across HH, our Research & Development Division, Medical Affairs, Regulatory , Legal etc. as well as external partners (diagnostic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …sites. These business functions include: Clinical Operations , 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,… more
- Merck & Co. (Rahway, NJ)
- …innovative medicines that help people across the globe. Competitive Intelligence Director Individual will be responsible for providing Competitive Intelligence (CI) ... area capabilities. Partnering with key stakeholders, individual will benchmark competitor clinical data, business models and capabilities to develop insights and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liasions to ensure ... successful implementation of CDx and data collection- Supports Regulatory affairs in providing content and providing review of documents supporting CDx submissions… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …work closely with cross-functional project teams, including Clinical Development, Clinical Operations , Biometrics, and Regulatory Affairs personnel to ... development and regulatory requirements of a clinical program. The Director will provide high...Writing team. Essential Functions Provides strategic input to support clinical operations and regulatory submissions… more
