- Organon & Co. (Jersey City, NJ)
- …the organization's business objectives. + Collaborate with cross-functional teams, including clinical development, regulatory affairs, marketing and sales, to ... medical strategies that drive business outcomes. + Strong understanding of clinical development, regulatory requirements, and commercialization processes. +… more
- Integra LifeSciences (Plainsboro, NJ)
- …may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs. + Project Management aimed to ... technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. As required, conduct… more
- Merck (Rahway, NJ)
- …skills, and a background in pharma/biotech. Previous experience with implementing and managing clinical and regulatory data standards is a big plus. If you ... but are not limited to:** + Identifying, evaluating & implementing new scientific, clinical and regulatory reference data sources + Ensuring timely authoring,… more
- Sanofi Group (Morristown, NJ)
- … clinical pharmacology or ECET components of investigator brochures, regulatory documents. + Interact effectively with managers from various disciplines; serve ... & Decision Science), Early Development Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety… more
- Actalent (Princeton, NJ)
- …work in a fast-paced environment and manage multiple priorities. + Proficiency in clinical trial management systems (CTMS) and regulatory submission platforms. + ... We are seeking a dedicated Senior Clinical Project Manager responsible for overseeing the planning, execution, and management of clinical trials across multiple… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …medical strategies that drive scientific and business impact. + Experience in managing clinical trials and regulatory submissions. + Experience in leading and ... innovation. The ideal candidate will have extensive experience in medical affairs, clinical development, and a proven track record of successful leadership in the… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …concept ideation, interaction with cross functional development teams, and assessment of clinical evidence requirements to meet regulatory , safety and efficacy ... new and existing LSM products for the BU + Reviews all Clinical Study Reports and regulatory submissions to ensure adequacy of support for all claims pertaining… more
- Merck (Rahway, NJ)
- …and applicable laboratory testing regulations. + Experience ensuring compliance of a clinical laboratory with regulatory standards. + Experience with the ... Molecular Biomarkers is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of … more
- Cytel (Trenton, NJ)
- …science, model-informed drug development), to provide strategic advice to define optimal regulatory , clinical and/or market access pathways and promote faster ... recognized thought leader and strategic advisor in the areas of optimal regulatory , clinical development and/or market access pathways and quantitative… more
- Bristol Myers Squibb (Princeton, NJ)
- …the BrCa space + Manages relationships with key internal stakeholders including Regulatory , Clinical , Commercial, Medical Affairs & Communications and external ... facilitates the transition of drug candidates from early to late-stage clinical development, their approval and life cycle management. Early-stage translational… more