- Insmed Incorporated (Bridgewater, NJ)
- …with Regulatory project leads in the US, EU, and Japan, the Director , Regulatory Labeling will be responsible for creating (and/or updating) labeling ... Best Workplaces for Millennials™ lists.OverviewThis is a key role providing regulatory expertise and guidance to internal stakeholders for successful development and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director will provide ... level strategic input into development plans, study designs, and regulatory submissions. The Director will provide direction...This role will be a senior member of the Regulatory , Quality and Clinical Reporting (RQC) team,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference?The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You ... will lead a global regulatory team to develop and execute regulatory ...to lift 0-10 lbs. Development of People Ensure that reporting personnel have individual development plans (IDP), with annual… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …operational and project management capabilities are essential for success. Relationships Reporting to the Director of Medical Omnichannel Engagement (MOE). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Associate Director , Medical Affairs Omnichannel Engagement, role is to support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, maintenance, ... and enforcement of data standards, demonstrated knowledge of industry standards related regulatory requirements (CDISC), FDA & ICH, PMDA, EU & ICH, CRP and… 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, ... 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
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate with ... clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs, Product Development, Research and Development (R&D), Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the design and ... Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... change. Are you ready to make a difference? The Position The Associate Director , Process Chemistry will be responsible for the design, development and staffing of… more
- Insmed Incorporated (Bridgewater, NJ)
- … Director , Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director , Head of Toxicology and Molecular Mechanisms. In ... DABT/DACVP certification preferred. Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Merck & Co. (North Wales, PA)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting , and publication.-Specifically, the Director ... and dedicated colleagues while developing and expanding your career.The Clinical Director (Principal Scientist) has primary responsibility for the planning and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director , Omnichannel Marketing and Media position reports to the Senior Director , Omnichannel ... deliver omnichannel and media specific marketing input and activities.The Associate Director of Omnichannel Marketing and Media is responsible for managing,… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director of Biostatistics is responsible for the statistical aspects for complex ... protocol statistical section development, study setup, execution, analysis, and reporting of clinical trials, and interacts with cross-functional teams.ResponsibilitiesAdditional… more
- Merck & Co. (North Wales, PA)
- …Functions & Responsibility Essential function(s) includes, but is not limited to: Reporting to Senior Management of the Medical Device and Combination Product (MDCP) ... Quality Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …delivery of medical coding for clinical trials, clinical development, and regulatory submissions. Develops and proposes strategies for medical coding and coding ... through outsourcing (eg, study startup, study conduct, study closeout, and reporting ).Provides oversight to CRO pertaining to medical coding, coding standards, and… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics ... communication/publication components of overall medical operating plan.The Sr Medical Director provides strategic development, planning, implementation, and oversight of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …communications for QA, QA projects as assigned, ensuring onboarding of N-3 leaders directly reporting to the VP of Quality, and in close collaboration with the QA ... projects assigned to individuals are current and up to date- Support regulatory inspection related activities as required- Support Head, Global strategy and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will ... lead will also contribute to the program study strategy, planning, execution, and reporting outputs in collaboration with the CS Asset LeadsThe CS Group Lead will… more
