- Bristol Myers Squibb (Princeton, NJ)
- …pharmacokinetics activities of multiple projects; be responsible for preparation of regulatory dossier / submissions; and assist in developing strategy for the ... DSUR, etc. to support clinical trials and global registrations. Interacts with regulatory authorities to address questions as needed. + Support clinical assets for… more
- Merck (Rahway, NJ)
- …point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the ... (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations) + Provide clinical… more
- Bristol Myers Squibb (Princeton, NJ)
- …activities for the pipeline and supports late stage portfolio for regulatory , translational development and life cycle management. Translational Development drives ... Participates in post-hoc biomarker analysis and publication efforts + Supports regulatory submissions and regulatory interactions as needed **Skills/Knowledge… more
- Sumitomo Pharma (Trenton, NJ)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… more
- Merck (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Lilly (Branchburg, NJ)
- …external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and ... SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. + Ensure control… more
- Bristol Myers Squibb (Madison, NJ)
- …trials and will supervise and have accountability for the clinical components of regulatory filings + Will contribute to overall strategy for specific disease / ... and Communication + Will work closely with colleagues in BMS Research, Development, Regulatory , Medical, Commercial and other key functional areas on a global basis;… more
- Bristol Myers Squibb (Princeton, NJ)
- …material oversight. Participate in relevant internal and joint governance meetings. + ** Regulatory & Documentation** : Author and review sections of regulatory ... concerning raw material controls. Prepare responses for information requests from regulatory bodies. + **Team Leadership** : Manage and mentor team members,… more
- J&J Family of Companies (Titusville, NJ)
- …and for final protocols, clinical study reports, and clinical components of regulatory packages/submissions. He or she may delegate some of these responsibilities, ... and with functional partners from global medical affairs, health care compliance, legal regulatory , and other relevant groups. + The VP NP is responsible for final… more
- Merck (Rahway, NJ)
- …oral, parenteral, and specialty dosage). The director should be well engaged with regulatory and industry trends to guide future activities for Analytical R&D and ... DSCS. The candidate will have experience in an innovative analytical/ regulatory /GMP environment. The Director will effectively partner with the SMAR&D leadership… more