- Novo Nordisk Inc. (Plainsboro, NJ)
- …with internal SOPs and Federal and State regulations, including compilation and submission of any required documents to regulatory agencies. Supervise designated ... packages for FDA meetings (pre-IND, EOP 2, pre-NDA, pre-BLA) for review by Project Leaders Write Regulatory documents translating team strategy into … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... Prepares content templates and leads technical team in preparation of submission documents; authors regulatory documents where necessary with supervision.Health… more
- Eisai, Inc (Nutley, NJ)
- …dossiers, supplements, amendments, as well as providing strategic product direction to project teams on interacting and negotiating with regulatory agencies in ... and answers any questions. This includes oversight, guidance, and management of GRS teams responsible for large, late stage... of existing products. May serve as the lead regulatory representative on the project team throughout… more
- Merck & Co. (Rahway, NJ)
- …Process Improvements, Project Information Management , Project Management , Project Planning, Regulatory Compliance, SAS Macros, Social ... (SDS QM), provides oversight and quality management of submission data standard deliverables for world-wide regulatory application submissions of… more
- Genmab (NJ)
- …and industry data standards (eg, CDISC/CDASH).Excellent cross-functional communication and project management skills.Experience supporting regulatory filings ... CollaborationCollaborate with Trial Management , Clinical Operations, Medical, Biomarker Management , Biostatistics, Medical Writing, and Regulatory Affairs to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. ... and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses and help submission team in quick turnaround… more
- Merck & Co. (Rahway, NJ)
- …eight (8) years of technical expertise in cell culture sciences, leadership and project management , and regulatory knowledge in the Pharmaceutical/Biotech ... and trend evaluations, process characterization, new WCB qualification, and regulatory submission authoring, with a focus on...of technical expertise in cell culture sciences, leadership and project management , and regulatory knowledge… more
- Merck & Co. (North Wales, PA)
- …reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)Strong project management skills; leadership at a program level; determines ... position is a key collaborator with statistics and other project stakeholders in ensuring that project plans...of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership… more
- Merck & Co. (North Wales, PA)
- …software development life-cycle (SDLC) US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic ... 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)
- …investigations and trend evaluations, process characterization, new WCB qualification, and regulatory submission authoring, with a focus on standardization ... environment, focused on common goals and working across boundaries. -Acute problem-solving skills, project management , and keen ability to navigate work in an… more
- Merck & Co. (Rahway, NJ)
- …or regulatory authorities.Prepares critical summaries and expert reports to management and/or for submission to regulatory agencies.Supervise trainees ... procedures - Plan and coordinate the monitoring and data management activities of each study.Ensure that the study is...the Final Study Report Maintain contact with all stakeholders ( project leader, regulatory affairs, quality assurance etc.)… more
- Merck & Co. (Rahway, NJ)
- …dossier (IMPD), and new drug application (NDA)/ worldwide marketing application (WMA) submission documents across the project development lifecycle, as well as ... oral, sterile and combination products. You will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities will… more
- Formation Bio (New York, NY)
- …and that messaging is consistent throughout all technical documentation to reflect the project and regulatory strategies and requirements. Reviews work of other ... clinical summaries and overviews, and clinical study reports (CSRs); regulatory documents (meeting and briefing packages, regulatory ...in moving any of these documents to completion. Keeps management current on project status and provides… more
- Merck & Co. (Rahway, NJ)
- … guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses (biologics license application submission ) and ... is expected to provide scientific expertise, and creativity to solve complex project problems across the large molecule portfolio.-They will be accountable to… more
- Eisai, Inc (Nutley, NJ)
- …Agility, Industry/ Regulatory Knowledge, Mentoring/ People Development, Project Management , Statistical Programming Skills, Vendor ManagementEisai Salary ... and drug development plans within the clinical development. Works with the clinical, project management , and data manager teams on strategic designs of studies;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to create and maintain the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient and effective organization ... portfolios, in alignment with the business strategy Lead the DSG inspection management activities by ensuring continued submission , compliance and inspection… more
- Genmab (NJ)
- …one study are in scope.The Programming Manager will support the Data Management , Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker functions with ... specification and pooling of data across clinical trials within the same project .Supports in-house production of analysis datasets, tables, figures and listings, by… more
- Genmab (NJ)
- …Statistics, Drug Safety, Medical, Clinical Pharmacology,Translational Research, Medical Writing, Project management , and Regulatory . Responsibilities/tasks - ... by ensuring that the programming package is consistent with current electronic submission standards and guidelines and meets project team needs. Supports… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... protocol profiles, and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical… more
