- Merck & Co. (Rahway, NJ)
- …Description: Associate Director, Process Engineer - Oral Solid Dosage, Clinical Manufacturing The Formulation, Laboratory, and Experimentation (FLEx) Center is ... a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.-This team works with… more
- Merck & Co. (Rahway, NJ)
- … Trials Regulation of the European Union). Responding to internal and clinical review comments on public disclosures; amending disclosures as appropriate ... content with internal and external reviewers, and guiding the posting through review and approval. Collaborating with clinical teams, including requesting… more
- Merck & Co. (Rahway, NJ)
- …and posters/oral presentations that report results from our company's General Medicine clinical trial program, as well as select early-stage development projects and ... collaborate with our Research & Development Division colleagues from Global Clinical Development, the Center for Observational and Real-World Evidence, Global… more
- Merck & Co. (Rahway, NJ)
- …subsidiaries for all applications and submissions and responsible for regulatory review and final approval for all submissions and associated documentation. Provides ... and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. Key Functions Reports to… more
- Merck & Co. (Rahway, NJ)
- …and/or subsidiaries for all applications and submissions.Responsible for regulatory review and final approval of all submissions and associated ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Provides leadership to the Global… more
- Merck & Co. (Rahway, NJ)
- …tools, and requirements for all dosage forms (liquid, lyo, drug-device combinations) Review and approval of data and technical documentsAbility to recruit, select, ... with exposure to all stages and aspects of development (preclinical, clinical , and commercial) and cGMP industrial backgroundExperience in developing sterile and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... medical topics, and supports PV Operations' medical review function. This position supports a senior physician in evaluating and mitigating safety signals as they… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan ... Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions from sites/… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with PSL(s) or Clinical Safety Physician(s) for assigned product(s) or clinical studies to review and revise CSPs, ICFs, Clinical ... centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple… more
- Novo Nordisk Inc. (New York, NY)
- …standing by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. Qualifications At least 3 years of relevant experience ... pharmaceutical sales experience; pharmaceutical sales experience preferred. Marketing or clinical experience preferred. A Bachelors degree required, scientific degree… more
- Merck & Co. (Rahway, NJ)
- …anti-obesity drugs with different modes of action based on projected clinical benefit and provide means to explore favorable drug combinations.- Furthermore, ... it could be used to explore the impact of different background therapies in clinical obesity trials.- The postdoctoral scientist will have the opportunity to work in… more
- Aequor (New York, NY)
- …approaches and tools in health services research is required, eg, literature review , clinical data interpretation and claim data analysis Knowledge of ... data science desirable Knowledge of health economic methodologies desirable Knowledge of international health systems, health technology assessment and pharmaceutical economics preferable Experience with using Microsoft Excel and PowerPoint Excellent oral and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; ... of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manager Grade level. This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role as CSO ( Clinical ... streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential… more
- Merck & Co. (Rahway, NJ)
- …(TPL) in Manufacturing Division is:Accountable to the Development Commercialization Review Committee (DCRC) for delivering a fully integrated stage-appropriate ... development through to commercial manufacturing.- Deep understanding of connectivity between clinical , CMC, and HH to successfully launch a new product. Technical… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary Job Summary The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, ... start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead(s). Plans, support , creates, and communicates clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …& retention activities Obtain expert medical community input Regulatory liaison: Write and/or review clinical sections of clinical trial reports, statistical ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...as Site Selection and Initia-tion trainings for the monitors Review medical monitoring plan and conduct monitoring activities as… more
- Merck & Co. (Rahway, NJ)
- …of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to ensure ... device sites with the collection and analysis of data for management review . Reports to - Director Regulatory Compliance, Device Quality and Regulatory Location… 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 ... sub-team. The HEOR-ESS sub-team is part of a larger Clinical Data Science and Evidence (CDSE) team which sits...Responsible for ensuring scientific rigor by serving as MMRC reviewer on real world evidence and modelling projects Work… more
