- Bristol Myers Squibb (Summit, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director of Clinical Quality Audit strategy is responsible ... of critical quality risks and issues that may affect BMS. The Senior Director , Clinical Quality Audit strategy is also responsible for effectively… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director Clinical Development... results and provide a guidance to prepare high quality reports working with Medical Writing + Working with ... within the respiratory clinical development program at Teva! The Senior Director , Clinical Development is responsible for the development, execution and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …projects through early and late phase development. The Director reports to the Senior Director Clinical Sciences and collaborates closely with Medical ... The Director Clinical Sciences, Hematology, leads in...and independently supports the development of regulatory documents; performs quality review and/or approval; adjudicates and resolve cross functional… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and assuring effectiveness in delivery on quality objectives and a strong quality voice. Additionally, the Senior Director will collaborate closely with ... by advancing the care of patients with life-threatening diseases. ** Senior Director , GVP** **Audits** The Senior...for driving the integration and peak performance of R&D's Quality Management System, across Clinical Development and… more
- System One (Florham Park, NJ)
- …of 8 -10 years ( Director ) or, minimum 10-12 years ( Senior Director ) of experience in medical operations, clinical operations, or a related field within ... Job Title: Director / Senior Director , Medical Operational...clinical operations, regulatory affairs, commercial and marketing, and quality assurance, to drive alignment and achieve operational goals.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …SOPs, company policies and regulatory guidelines to provide timely and high- quality clinical data that supports global registration and commercialization ... help create possible, together. **Job Description** We are seeking a strong, experienced Clinical Operations leader for a Director position within our Oncology… more
- Matheny Medical and Educational Center (Peapack, NJ)
- Senior Director of Information Services EOE...mission is to provide exceptional care and an optimal quality of life for children and adults with special ... Matheny Medical and Educational Center has a career opportunity available for aFull Time Senior Director of Information Services. Our Core Values: + Respect +… more
- Sanofi Group (Bridgewater, NJ)
- …for patients and their families. Join our **Biostatistics Rare Diseases as Senior Statistical Project Leader ( Director )** and you'll provide statistical ... leadership, guidance, and strategic input for clinical studies in one or more project teams. You'll...with other statistics project leaders, and in communicating with senior leadership. + Mentor junior project team members and… more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. As a Senior Director in Health Economics and Outcomes Research (HEOR), you will be ... strategic plans for asset candidates, including studies on burden of illness, real-world clinical outcomes, epidemiology, quality of care, and unmet needs. +… more
- Merck (Rahway, NJ)
- …leader to drive pipeline impact and lead a talented group of pharmacometricians. This Senior Director is expected to be an experienced pharmacometrician with a ... QP2 efforts to strengthen our pharmacometrics capabilities on a continuous basis. The Senior Director will be accountable for directing a team of… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. ... is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management… more
- Merck (Rahway, NJ)
- **Job Description** The Global Clinical Supply (GCS) organization, within our Research & Development (R&D) Division, is accountable for managing the 'end-to-end' ... integrated clinical supply chain across all of the R&D portfolio...service activities to ensure supply continuity that meets our quality , compliance, and regulatory standards. + Strategic collaboration with… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Merck (Rahway, NJ)
- …a lead Global Clinical Supply Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate ... effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …short- and long-term goals, lead the MR group to deliver timely and high- quality medical review, ensure the MR process and procedure in alignment with regulatory ... in Patient Safety cross-functional teams. + Communicates to highest levels of senior management key pharmacovigilance findings. + Oversees or performs medical review… more
- Merck (Rahway, NJ)
- …Ingredient (API) processes meet target yield, purity, and physical attributes for clinical programs across the diverse pipeline. As a recognized expert in the ... Lab Lead will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and… more
- Bristol Myers Squibb (Madison, NJ)
- …automated, efficient organization dedicated to achieving industry-leading medical quality , compliance, and cost effectiveness. Builds Medical Review capabilities ... abilities. Medical Review: Provides guidance regarding medical review of individual clinical trial and post-marketing reports. Oversees single case processing vendor… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …statistical support to clinical studies or programs with the guidance of senior level statisticians (ie, Associate Director or higher) which includes, but is ... Senior Manager Clinical Statistician Date: Jan...for budget planning. + Manage and Deliver assignments with quality and within timelines. + Possible to have direct… more
- Bristol Myers Squibb (Summit, NJ)
- …project/products, to Health Authorities and RGO . + Translate risk factors into Clinical Quality Assurance oversight plans, including internal and external audit ... Medicine + Oversee the Data generation and data integrity from laboratory work and non- clinical phase projects + Ensure Quality is Designed into non- clinical … more
- Bristol Myers Squibb (Summit, NJ)
- …writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality in collaboration with Medical Writing. Present to ... a ctivities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review .… more