- Eisai, Inc (Nutley, NJ)
- …health economics. The role requires a strong technical background in evaluating clinical data and leading HEOR analyses such as systematic literature reviews, ... work independently to complete analyses while proactively providing updates to the project team and according to timelines and requirements. The candidate should… more
- Merck & Co. (Rahway, NJ)
- …development and design control principles to positively support and influence clinical and commercial combination product development and launches to ensure they ... communication to cross-functional stakeholders, including external suppliers. Proactively resolve project obstacles and challenges and communicate device development strategy… more
- Merck & Co. (Rahway, NJ)
- …a collaborator, ensuring patient access objectives and strategy are linked to clinical development, commercial and value evidence plans by championing the market ... functional teams including: Marketing and Product Development Teams (PDTs), R&D (ex. clinical , OR and medical affairs), and regional and country access teams. As… more
- BioAgilytix (San Diego, CA)
- …Manager II will lead scientific and operational activities in support of preclinical, clinical , and product release studies for our San Diego lab. This role requires ... while also playing a key role in client engagement, project delivery, and cross-functional collaboration.Essential ResponsibilitiesLead team(s) developing and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position works for approximately 20 hours per week. Responsibilities: Project Title: Multimodal foundation models for integrating diverse biological dataThe ... challenge, such as identifying novel biomarkers for cancer treatment. The project will address limitations of unimodal approaches, including noise sensitivity and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for approximately 37.5 hours per week. Responsibilities: Summer Intern Project Plan: SAS Global Macros Standardization & DeploymentProject TitleSupporting Global ... Science. Coursework or exposure to statistical programming in SAS and clinical data standards.Skills: Proficiency in Base SAS and Macro programming. Understanding… more
- Insmed Incorporated (NJ)
- …Summary Reports) Assist/co-author requirements, testing, specification, and other validation project deliverables Ensure training requirements are complete for ... team members (CSV SOP, Test Execution, Gdoc. Etc.) Guide project team members on CSV projects ensuring team members...CFR Part 11, Annex 11, GAMP 5, GMPs, Good Clinical Practices, Data Integrity.Strong technical writing skills for authoring,… more
- Insmed Incorporated (NJ)
- …programs. This role will provide regulatory input to global cross-functional project teams throughout product development and submission activities. The GRL will ... Do: Lead development and execution of global regulatory strategies for clinical , pre- clinical , and lifecycle management activities for assigned programsIdentify… more
- Eisai, Inc (Exton, PA)
- …be expected to effectively manage the alliance with the CROs/CDMOs to meet project timelines. The ability to function in a fast-paced, highly technical environment, ... be expected to effectively manage the alliance with the CROs/CDMOs to meet project timelines. The ability to function in a fast-paced, highly technical environment,… more
- Insmed Incorporated (NJ)
- …Do: Support aspects of tactical implementation for assigned projects including project timeline planning and documentation workflow management for global regulatory ... and act as a point of contact for cross-functional teams (eg, Clinical , Nonclinical, CMC) to ensure effective coordination and execution of regulatory deliverables… more
