- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data ... more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functional teams in the analysis and redesign of business processes. Ensure compliance with regulatory standards (eg, ICH, FDA, or other industry-specific ... more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technology and data analytics to enhance decision-making and streamline operations. Ensure compliance with regulatory requirements and industry standards in all ... more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Accounting, Tax, Compliance and Legal team members to ensure compliance with all relevant regulatory , accounting, tax and internal requirements. This ... more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …limited to Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety ... more
- Merck & Co. (Rahway, NJ)
- …issues management .Strong understanding of the pharmaceutical industry, including regulatory frameworks and compliance issues.Proven track record in leading ... more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... more
- Merck & Co. (Rahway, NJ)
- …team and with external partners.Understand and apply regulatory and compliance requirements relevant to device risk management activities, ensuring adherence ... more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in ... more
- Merck & Co. (Rahway, NJ)
- …of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design ... more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a ... more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... more
- Merck & Co. (Rahway, NJ)
- …or facilitating teams involving source area representatives in a matrix management environment).Identifying trends and/or potential compliance gaps and ... more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe role of Director , Global Oncology Communications, is a unique opportunity to join our company, a recognized leader in oncology, as a key member of ... more
- Merck & Co. (Rahway, NJ)
- Job DescriptionR5 - Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsT he (remote) position is only applicable for those that are not within ... more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …functions, and compliance across clinical development, medical, and regulatory roles/processes/SOPs Develop and implement knowledge management technology ... more
- Genmab (Plainsboro, NJ)
- …(in line with Target Product Profile). For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented ... more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... more