- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …all **pharmacometrics** activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions . You will conduct analysis, execution and reporting of ... + Author **pharmacometrics sections** of clinical pharmacology documents for regulatory filings including annual reports, investigator's brochure, IND/NDA applications… more
- Prime Therapeutics (Trenton, NJ)
- …efficiencies through process improvements for paralegal services + Manage regulatory submissions , filings, renewals, notifications, and periodic reports ... Review (UR), business and state registrations) + Research and respond to regulatory inquiries + Other duties as assigned **Minimum Qualifications** + Paralegal… more
- Organon & Co. (Jersey City, NJ)
- …Provide medical expertise and strategic guidance to support product development, regulatory submissions , and commercialization efforts. + Support business ... objectives. + Collaborate with cross-functional teams, including clinical development, regulatory affairs, marketing and sales, to ensure alignment of medical… more
- Datavant (Trenton, NJ)
- …understand how Datavant's solutions can solve their challenges in clinical trials, regulatory submissions , and real-world data generation. **You Will:** + Serve ... retrieval, with expertise in real-world evidence, clinical trial operations, or regulatory data submission. + Excellent communication skills with the ability to… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ Participates in post-hoc biomarker analysis and publication efforts + Supports regulatory submissions and regulatory interactions as needed ... activities for the pipeline and supports late stage portfolio for regulatory , translational development and life cycle management. Translational Development drives… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream ... processing. + Collaborate closely with Downstream MSAT, Validation MSAT, QA, Regulatory , Process Development, and CDMO technical teams. + Stay current with… more
- Lilly (Branchburg, NJ)
- …analysis. + Responsible for assisting in the communication of study results via regulatory submissions , and manuscripts, as well as for communicating one-on-one ... statistical analysis plans, write reports and communicate results, assist/respond to regulatory queries. + Assist in and/or be accountable for selecting statistical… more
- Merck (Rahway, NJ)
- …study design and analysis and reporting through all phases of development including regulatory submissions + Demonstrated history of development and execution of ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Astrix Technology (Essex County, NJ)
- …improvements. + Contribute to the creation of technical documentation to support regulatory submissions , global market entry, and ongoing compliance. + Ensure ... initiatives across product development, method validation, risk assessment, and regulatory compliance. **Key Responsibilities:** + Lead the design and execution… more
- AbbVie (Florham Park, NJ)
- …methodologies and innovations in drug development spanning trial design, monitoring and regulatory submissions , as well as post-marketing access. As a Senior ... to advance medicines to our patients. Role Responsibilities: + Support regulatory submission and product life-cycle management strategy planning and implementation.… more