- 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 ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... capture all communications via contact reports.Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. 15 E- Work with the business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as… more
- Merck & Co. (Rahway, NJ)
- …and strategies to ensure optimal quality and compliance in Global Regulatory Affairs and Clinical Safety business processes.Core Responsibilities may include ... Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs &… more
- Merck & Co. (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical device ... medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality … more
- Merck & Co. (Rahway, NJ)
- …knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and safety .NOTICE FOR INTERNAL APPLICANTSIn ... accelerate process and product development and manufacturing and ensure safety and quality of our products. The...Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... of Director in the CCFS group and working in conjunction...next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and ... the indication of interest.Work closely with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs, statistics,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …seasoned leader to strengthen and grow the Learning and Development program across the Regulatory - Safety - Quality (RSQ) function. In this role you will evolve ... and help create possible, together. **Job Description** The Central Quality Services team within R&D Quality is...program effectiveness + Foster and drive a culture of quality and continuous improvement across RSQ and Development **Change… more
- Merck (Rahway, NJ)
- …and strategies to ensure optimal quality and compliance in Global Regulatory Affairs and Clinical Safety business processes. Core Responsibilities **may** ... **Job Description** The Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... via contact reports. + Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety ...all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly Reports) in paper and electronic format.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company… more
- Hackensack Meridian Health (Edison, NJ)
- …mission to transform healthcare and serve as a leader of positive change. The ** Director of Patient Safety and Quality , Inpatient** , provides leadership, ... outcomes. **Responsibilities** A day in the life of a ** Director of Patient Safety and Quality...and analysis. + Stays abreast of and communicates all regulatory compliance changes and incorporates findings into all resident/patient… more
- System One (Basking Ridge, NJ)
- …Effectively coordinate and manage available resources in developing and delivering high- quality safety evaluation related documents/deliverables on time. - ... Director Clinical Safety 12 month contract... Director Clinical Safety 12 month contract Hourly Pay Max: $100-...regulatory , but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of… more
- Bristol Myers Squibb (Summit, NJ)
- …here at BMS with our Cell Therapy team. The primary focus of the **Associate Director , EHSS Environmental, Emergency Response, and Fire / Life Safety ** is to ... (BMS) for the Summit Facility within the Department of Environmental, Health, Safety and Sustainability (EHSS). This position will work closely with the… more
- Parsons Corporation (Newark, NJ)
- …you're looking for. **Job Description:** **Parsons is looking for an amazingly talented** **Assistant Safety Director ** **to join our team! In this role you will ... and related services._ **What You'll Be Doing:** **Assist the Safety Director in developing and implementing ...safe working environment.** **Keep abreast of industry best practices, safety standards, and regulatory requirements to ensure… more
