- 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 ... and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess...and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other aspects of drug … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for ... information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: - The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & ... of our company. - Position Description/Summary: - The GPAM Associate Director, Project Manager, is a core member of...Director, Project Manager, is a core member of Early Drug Development and/or Late Drug Development Teams,… more
- Merck & Co. (Rahway, NJ)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... on drug /vaccine development programs, and author or co-author strategic documents. Associate Directors are expected to have or be developing expertise in several… more
- Genmab (NJ)
- … drug development pertaining to statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory ... and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert supporting the...and technical progress within the field of biostatistics in drug development and advise of new methodologies that may… more
- Merck & Co. (Rahway, NJ)
- …degree is preferred.Leadership experience with working knowledge of device, biologic/ drug product, and process development including regulatory submission ... & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... responsible for performing a wide range of activities to support the release of drug products for human use. This position is responsible for quality and maintaining… more
- Genmab (NJ)
- …our best, and authentic is essential to fulfilling our purpose.The Role:An Associate Director, Data Management is operationally responsible for the oversight of ... delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will provide oversight to ensure end-to-end data management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission.The Associate Director will have routine interaction with key ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Principal Scientist of Device Technology Assessment and Early Development will spearhead early-stage device technology evaluation and ... focus on front-end development, emphasizing the exploration and assessment of emerging drug delivery device technologies. The ideal candidate will lead efforts in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- Merck & Co. (Rahway, NJ)
- …Modeling Team in our Company Manufacturing Division seeks an experienced Associate Principal Scientist who will develop and utilize advanced computational models ... modalities.- In this role, you will build and apply predictive tools for drug substance (upstream, downstream, and conjugation) and drug product manufacturing… more
- Merck & Co. (North Wales, PA)
- …that include coordinating the activities of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Respiratory will focus on driving strategy, development, and life-cycle ... understanding of the disease area, the functions and processes relevant to drug development, and project management principles as applicable to the pharmaceutical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted ... activities; collaborates closely with data manager to ensure high quality data. Drug Development Strategy: Provides input to multiple aspects of the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of the development ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor… more
- Genmab (Plainsboro, NJ)
- …issues to CPL in a timely mannerExecute operational strategies related to drug supply, regulatory submissions, and recruitmentBudget and PlanningAssist in the ... leading clinical projectsExperience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teamsSome experience with operational management and budget… more
- Genmab (Plainsboro, NJ)
- …and utilized at a pace never seen before. Join Genmab as an Associate Director, Solution Architecture and Engineering, R&D Digital Products as part of our ... Research data products, Lab systems automation, Development Operations, Pharmacovigilance, Regulatory , integration and Data visualization.At least five years of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and management to drive strategies and activities for early and late phase drug development candidates within the team to support overall CMC development plan.- ... Represent CMC development project teams on cross-functional drug development project teams with a predominately operational focus; ensuring to establish good working… more
