- Merck (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... analyses + Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory … more
- Bayer (Whippany, NJ)
- …is scientifically accurate and medically appropriate; + Collaborates with legal and regulatory to develop a consistent process and ensure consistent reviews of ... medical matrix meetings with internal customers (eg, Sales, Marketing, Clinical Research, Regulatory , PQC, Legal, GMS) in order to fully utilize and coordinate… more
- Merck (Rahway, NJ)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... and interpretation of data. + Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents and… more
- Merck (Rahway, NJ)
- …on programs. + Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics (monoclonal antibodies, antibody ... drug conjugates, T-cell engagers, bispecifics) in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and not limited to Clinical Supply Planning and Management (CSPM), Clinical Operation, Regulatory , Quality and the rest of PDM) to ensure alignment of the ... communicating risk mitigation plans. + Partners with Procurement, Quality and Regulatory for the identification, qualification and management of comparator sourcing… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all the ... develop the drug in accordance with a clinical and regulatory strategy. + Working with experts and consultants in...writing). + An advanced understanding of clinical medicine and science . + Advanced understanding of drug development principles and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... operational execution and excellence by applying best practices in accordance with regulatory requirements and guidelines worldwide, and in alignment with the CSPV… more
- Sanofi Group (Morristown, NJ)
- …function serves as a valued strategic partner with Digital, Clinical, Commercial, Regulatory , and Market Access on therapeutic solutions to support patients' needs. ... support Sanofi's deep commitment to chasing the miracles of science to improve the lives of patients. We are...**About You** + Advance degree in Medical / Bio-sciences ( PhD , PharmD, MD) with 5+ years of relevant Medical… more
- RELX INC (Trenton, NJ)
- …convey information clearly to senior stakeholders Highly Desired Skills and Experience: + PhD or Master's degree in Computer Science , Mathematics, Statistics, or ... of RELX, is a leading global provider of legal, regulatory , and business information. We help customers increase productivity...best practices + Driving best practices across our data science functions + Setting strategy and team direction, with… more
- Exelon (Carneys Point, NJ)
- …business strategies. **Preferred Qualifications** **PREFERRED QUALIFICATIONS** + Master's degree or PhD in Computer Science , Data Science , Artificial ... all ML programs meet performance specifications, key business metrics, and regulatory compliance standards while staying aligned with corporate AI/ML governance.… more