- Organon & Co. (Jersey City, NJ)
- …+ Lead the Global Regulatory Teams, which coordinates cross-functional regulatory support for development programs and marketed products + Independently interact ... interactions with foreign agencies working closely with regional colleagues to support their interactions and provide strategic direction across multiple regions… more
- Ascendis Pharma (Princeton, NJ)
- …safety data exchange/pharmacovigilance agreements with license partners and distributors in support of process definition, monitoring and other roles as required by ... . Assists in the preparation and review of safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study… more
- IQVIA (Parsippany, NJ)
- …(CRF) completion and submission, and data query generation and resolution. May support start-up phase. * Ensure copies/originals (as required) site documents are ... the Trial Master File (TMF) and verify that the Investigator 's Site File (ISF) is maintained in accordance with...and liaise with study team members for project execution support as appropriate. * If applicable, may be accountable… more
- Sanofi Group (Bridgewater, NJ)
- …and/or registries (eg: protocol, Key Results, Clinical Study Report) + Support other clinical development activities (eg pressure test and cluster feasibility, ... from health authorities + Provide appropriate medical input & support for all activities related to clinical studies such...and/or contribute in the the clinical section of the Investigator 's brochure, CTA, IND, DSUR, INDAR, DRMP, RMP +… more
- Mount Sinai Health System (NJ)
- …opportunity for a physician to gain valuable work experience while enjoying the support of colleagues in a well-established and growing practice with a strong rooted ... of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's… more
- Mount Sinai Health System (NJ)
- …with the utmost integrity + Ability to lead change and build consensus to support change + Solid clinical and clinical data-related analytical skills + Ability to ... of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's… more
- Hackensack Meridian Health (Neptune City, NJ)
- …team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community. Together, we keep ... out the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which the role is assigned. This… more
- Merck (Trenton, NJ)
- …Responsibilities** + Develop and lead global regulatory strategies to support multiple indications, optimizing labels and achieving timely regulatory approvals. ... + Worldwide marketing applications + Clinical study protocols and reports + Investigator brochures + Local registration study protocols for secondary markets +… more
- Sanofi Group (Morristown, NJ)
- …regulations. + Review documents supporting clinical development such as Investigator 's brochure, regulatory documents for IND/CTA, clinical sections of integrated ... development plans, and submission dossiers for regulatory approval. + Support drug registrations (contribution to submission dossiers label draft, regulatory… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …and all affiliates are inspection ready, oversee clinical trial and submission support , lead the R&D audit program, engage with regulatory authorities, and maintain ... of clinical facility and system audits at all relevant facilities, investigator sites, and vendors (including contract research organizations) and ensure that… more