- Merck & Co. (Rahway, NJ)
- …sciences, information science, pharmacy, or related scientific discipline plus literature-related regulatory reporting Bachelor's and 5+ years Master's/PhD and ... Develops, with input from internal stakeholders and knowledge of current regulatory requirements, article selection, adverse event reporting , editorial, and… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting , and publication.Specifically, the Director may be ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (North Wales, PA)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting , and publication.-Specifically, the Director may be ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (North Wales, PA)
- …cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting , and publication.Specifically, The Director May Be ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …local and global project teams. This role will be a senior member of the Regulatory , Quality and Clinical Reporting (RQC) team, and will provide mentorship and ... project teams, including Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs personnel to manage preparation of the written deliverables… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the latest technologies and tools available Gather business requirements for reporting and analyticsEngage with key stakeholders, including Regulatory Affairs ... as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory … 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
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces for Millennials™ lists.OverviewThis is a key role providing regulatory expertise and guidance to internal stakeholders for successful development and ... implementation of global regulatory labeling strategy for Insmed marketed and to-be-marketed productsResponsibilitiesIn close collaboration with Regulatory … more
- Aequor (TX)
- … reporting requirements Support the implementation of project related " regulatory excellence" activities as part of QS continuous improvement initiatives. ... NBL Manager in Lifecycle Change Management projects. Pro-actively interacting with Site Regulatory Assessors on Change Notifications, providing a high standard of … more
- Merck & Co. (North Wales, PA)
- …data management (data collection, processing, storage, and retrieval) and worldwide regulatory data management and reporting requirements.Strong knowledge of the ... the area and/or companyMaintain knowledge of new technologies, industry standards, regulatory requirements, and our Company guidelines and SOPs.Able to work… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …are relevant to the industry and contribute to the innovation of new reporting systems.Establish and implement programming standards and comply with regulatory ... requirements among project team members and across all studies.Review deliverables before transfer to either internal or external clients ensuring quality.Qualifications: Successful candidates will be able to meet the qualifications below with or without a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and enforcement of data standards, demonstrated knowledge of industry standards related regulatory requirements (CDISC), FDA & ICH, PMDA, EU & ICH, CRP and ... processes. Working knowledge of early and late-stage submissions per local/ regulatory requirements, demonstrated ability to self-start, be solution-oriented with an… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and ... to the design of studies, writing of protocols and other study and regulatory -related documents for DCR-PHXC, and other programs Participate in the analysis and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …adequate systems and process support, including facilitation of respective regulatory inspection preparation, management and follow-up in collaboration with impacted ... flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations and metrics. Support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as well as providing strategic input into clinical trial strategy and regulatory development. With a holistic overview across the pipeline portfolio, the Lead ... Collaborates with cross-functional teams, including portfolio, marketing, medical, R&D, regulatory affairs, analytics, and other relevant NNI departments to define… more
- Insmed Incorporated (Bridgewater, NJ)
- …The Director, Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director, Head of Toxicology and Molecular Mechanisms. In this ... oversee safety pharmacology and toxicology studies, author nonclinical sections in regulatory submission documents, and address regulatory inquiries. This… more
- Merck & Co. (Rahway, NJ)
- … requirements.Preferred Experience and Skills:Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)Ability and ... predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development ... 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)
- …of the Pain clinical development strategy and clinical development plans. Reporting to the Vice President/Clinical Development, and collaborating directly with the ... etc.); Designs and implements clinical trials ensuring compliance with regulatory standards and industry best practicesOrchestrates and manages clinical aspects… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs, market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders to ... HCP / KOL strategy lead has a team of HCP and KOL strategists reporting to them. Essential Functions Brand/Therapy Area Management: Defines the pre-launch / launch… more
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