- 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
- 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
- Novo Nordisk (Plainsboro, NJ)
- …as the organization and contact volume grows. Relationships Reports to the Sr. Director , Patient Support Solution Quality / Safety Associate Director . ... the lead who is responsible for ensuring that all aspects of our patient quality and safety operations meets standards. This position requires a highly motivated… 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
- Actalent (Basking Ridge, NJ)
- …studies, post-marketing surveillance, signal detection, and regulatory submissions. The Director will ensure proactive safety monitoring through the ... Job Title: Director , Clinical SafetyJob Description The Director , Clinical Safety will be responsible for...+ Coordinate and manage resources to develop and deliver high- quality safety evaluation-related documents and deliverables on… 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
- Novo Nordisk (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... milestones and related payment schedules) + Advanced knowledge of Regulatory and Compliance requirements related to Pharmaceutical Pharmacovigilance/ Safety … more
- American Water (Short Hills, NJ)
- …seeking a water quality leader to join and help lead our operations. The* Director of Water Quality & Environmental Compliance* will be the point person for ... quality assurance programs. * Knowledge of government regulations related to water quality and employee/community safety . * Knowledge of current and emerging… more
- Novo Nordisk (Plainsboro, NJ)
- …internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal ... us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new… more
- CBRE (Trenton, NJ)
- VAS - Quality & Risk Management Director Job...comply with internal guidelines, and are in line with regulatory and client standards. This job is part of ... career with CBRE? About the role: As a CBRE Quality & Risk Management (QRM) Director , you...an additional requirement to comply with COVID-19 health and safety protocols, including COVID-19 vaccination proof and/or rigorous testing.… more
- Penn Medicine (Plainsboro, NJ)
- …of study specific case report forms, source document tools, show vigilance in patient safety , protocol compliance and data quality . This employee must adhere to ... your life's work? We are hiring for an Associate Director Oncology Research Operations to join our Cancer Services...from start to finish working closely with the CRU Regulatory coordinators to manage, review, and initiate trials to… more
- Novo Nordisk (Plainsboro, NJ)
- …scientific documents, safety monitoring, and data analyses. The International Medical Director will also assist the Sr. Medical Director in the development ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...to make a difference? The Position The International Medical Director serves as a subject matter expert for our… more
- Novo Nordisk (Plainsboro, NJ)
- …Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop ... Are you ready to make a difference? The Position The Senior International Medical Director serves as a subject matter expert for our products and related data within… more
- Interstate Blood Bank (Trenton, NJ)
- …defined procedures. - Compliance with records, if any. - Monitoring of established quality , safety , hygiene and environmental standards. - Inform the direct ... services in more than 110 countries and regions. The Director of Business Development - Cell Therapy will drive...Compliance with records, if any + Monitoring of established quality , safety , hygiene and environmental standards +… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director , Clinical Development will provide ... global regulatory filings. **How you'll spend your day** The Director , Clinical Development will foster relationships with opinion leaders in assigned… more
- Sanofi Group (Bridgewater, NJ)
- …studies, and real-world evidence (RWE) studies. + Ensure the generation of high- quality , scientifically rigorous evidence to support the safety , efficacy, and ... **Job Title:** Medical Director - Global Medical Evidence Generation **Location:** Cambridge, MA **About the Job** We are an innovative global healthcare company,… more
- Gentiva (Hamilton, NJ)
- …lives every day. **Overview** We have an exciting and rewarding opening for an **Executive Director - RN** to join our team to lead our new office operations in ... everything we do, day in and day out. **Executive Director Responsibilities:** As an **Executive Director ** ,...+ Demonstrates a commitment to excellence through focusing on quality care and/or service. + Incorporates continuous quality… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Study Reports with minimal guidance and independently supports the development of regulatory documents; performs quality review and/or approval; adjudicates and ... The Director Clinical Sciences, Hematology, leads in the development,...team meetings, scientific advisory boards, study steering committees and data/ safety monitoring meetings; may represent function in collaborative activities… more