- Formation Bio (New York, NY)
- …that trials are executed efficiently, on time, and in compliance with all regulatory requirements. The Director will manage a team of Clinical Trial Managers ... more
- Formation Bio (New York, NY)
- …and maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory requirements (eg, FDA, EMA), industry standards (eg, ... more
- Formation Bio (New York, NY)
- …including consulting statisticians and CROs, ensuring high-quality statistical deliverables and compliance with GCP and regulatory standards. About You Ph.D. ... more
- Formation Bio (New York, NY)
- …release, stability programs, change management , and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at ... more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... more
- Merck & Co. (Rahway, NJ)
- …and business outcomes) System Validation and Inspection readiness Vendor management Education: Bachelor's degree IT/Computer Sciences, Pharmaceutical Sciences or ... 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)
- …scientific rigor. Proactively identifying and escalating operational risks. Partnering with director -level management to develop and execute operational and ... more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small molecules ... more
- Merck & Co. (Rahway, NJ)
- …such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create and execute design ... more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... more
- Merck & Co. (Rahway, NJ)
- …or non-interventional research studies (including Post Authorization studies) in compliance with Good Pharmacoepidemiology Practice (GPP) and Standard Operating ... more
- Merck & Co. (Rahway, NJ)
- …reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In ... more
- Merck & Co. (Rahway, NJ)
- …and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and ... more
- Tris Pharma (Monmouth Junction, NJ)
- …materials, activities and related communications and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, ... more
- Merck & Co. (Rahway, NJ)
- …timely and accurate information and status updates to project sponsors and management .Champion compliance and safety; promote a culture of diversity, inclusion, ... more
- Merck & Co. (Rahway, NJ)
- …Responsibilities include, but are not limited to: Work closely with the group Director to shape and execute strategy for biological characterization in all stages of ... more
- Merck & Co. (Rahway, NJ)
- …via presentations to governance committees and other internal audiences.Partnering with director -level management to develop and execute scientific and ... more
- Merck & Co. (Rahway, NJ)
- …Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving ... more
- Fidelity Investments (Jersey City, NJ)
- …cause, and advise on corrective actionsOversee Brokerage issue and action plan management to ensure compliance with enterprise risk requirements utilizing the ... more
