- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director , Regulatory Operations - Dossier Planning is ... limited to, original INDs, original and supplemental NDAs/BLAs/MAAs. The Associate Director partners with the Head of Regulatory Operations in developing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …intelligence and is viewed as an expert in its application to the regulatory process .Qualifications: Successful candidates will be able to meet the ... Strategy in the Drug and Device Development and Commercialization process .Experience with developing and documenting regulatory strategies in coordination… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- 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 ad hoc member of Global Project Team (GPT) to address labeling issues… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and ... processes, guidelines, and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing ... on Component teams and/or serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liasions to ensure sucessful implementation of CDx and data ... collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team leadership or project management requiredAdditional experience in process improvement activities and implementation requiredUnderstanding of regulatory ... needed, involved in due diligence activities during the vendor selection process .Support establishment of and/or build CTOR processes and tools, as needed,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …awareness of best practices for reproducible data science, global regulatory requirements, internal guidelines and Standard Operating Procedures (SOPs)- Ensure ... AI/ML deliverables- Contribute, with limited supervision, to documents submitted to regulatory or pricing authorities- Proactively identifies and manages risks in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and PPQ as needed. Conduct data review and analysis, data-driven decision-making process , and support data transfer to the appropriate data repository - liaison ... Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses to regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …such actions. Participate in cross-functional teams responsible for regional and global process improvements in the operational efficiency of PJ Lead and Tech Unit.- ... 4 or More Years Extensive experience in project management, process , product, and/or analytical development activities and pharmaceutical/oncology project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality teams located in… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops ( Process Chemistry) will have responsibility for ... API/Intermediate/RSM manufacturing operations at Insmed's CMOs including tech transfer, process optimization, clinical/commercial manufacturing, process characterization and… more
- Merck & Co. (Rahway, NJ)
- …with deep working knowledge of device and/or biologic/drug product and process development including regulatory submission and approval processes.Has broad ... position will be responsible for applying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set… more
- Merck & Co. (Rahway, NJ)
- …the organization in 2023.We are seeking a leader to take the position of the Associate Director Global Marketing, who will be responsible for maximization of the ... late lifecycle opportunitiesSupport filing of new indications and other regulatory requirements, such as pediatric filingsCross-functional collaboration: foster strong… more
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical Development ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams of… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… 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 &...responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position… more
- Merck & Co. (Rahway, NJ)
- … regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research… more
