- New Jersey Resources (Wall Township, NJ)
- …actionable insights based on financial and/or industry analysis. * Provide support for regulatory affairs for rate case planning purposes. * Analyze complex ... filings, rate cases and capital projects. * Collaborate with Treasury and Regulatory Affairs to align financial strategy with funding and compliance… more
- J&J Family of Companies (Titusville, NJ)
- …quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, ... **POSITION SUMMARY:** The incumbent will serve as a Senior Director , Clinical Leader in Neurodegeneration, Neuroscience, with a focus... medical and compound-related issues + Working with Regulatory Affairs and global clinical operations to… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides ... with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD...programs after proof of concept through late-stage trials and regulatory submissions. + Provide medical and scientific… more
- Taiho Oncology (Princeton, NJ)
- …and EVD), across Taiho's portfolio. The role requires extensive collaboration within the Medical Affairs team, particularly with the product leads in Medical ... with a talented cross matrix team. Position Summary: The. Director will be accountable and lead the development of...the pharmaceutical industry and the role and responsibilities of Medical Affairs . + Working/solid understanding of the… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Ascendis Pharma (Princeton, NJ)
- …The Regulatory Project Manager will be an integral part of Global Regulatory Affairs , providing project management leadership to key global regulatory ... developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled,...the Ascendis pipeline. As a part of the Global Regulatory Affairs team, you will be responsible… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans....plans. The Clinical Pharmacology Lead will serve as the medical monitor and/or study director responsible for… more
- AbbVie (Florham Park, NJ)
- …projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs . The Associate Director works in partnership with ... programmers Data science experts (SSG) Patient safety experts (GMA Stat) Global Medical Affairs experts Additional Information Applicable only to applicants… more
- Bayer (Whippany, NJ)
- …or biological regulated environment within a regulated function which may include, Medical Affairs , Quality, Safety, or other similar area is required; ... Director , Digital Governance & LMR Lead** The Senior Director , Digital Governance & Legal Medical Review...(3) years in a regulated function which may include, Medical Affairs , Quality, Safety, or other similar… more
- Sanofi Group (Morristown, NJ)
- …Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy ... **Job Title:** Senior Clinical Research Director **Location:** Morristown, NJ Cambridge, MA **About the...the Senior CRD is to: + Provide ophthalmology focused medical and scientific expertise to the cross functional project… more