- 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …application is true to the best of my knowledge. **Job Description** The Regulatory Affairs-Labeling, Associate Director is responsible for ensuring that Takeda ... activities pertaining to global and local labeling compliance and quality within Global Regulatory Affairs. + Partners...Global Regulatory Compliance, Global Labeling, IT, Global Regulatory Operations, GPSE ( safety ), Regulatory … more
- Merck (West Point, PA)
- …to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and ready ... + Direct support of validation activities and all other associated Quality functions + Understands and applies regulatory /compliance requirements relative… 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
- 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Patient Safety Clinical Operations in Cambridge, MA, where ... the Pharmacovigilance Operations team, you will report to the Director , PV Clinical Operations and will be responsible for...+ Perform certain key tasks to ensure high data quality and efficiency + Support study specific Inspection and… 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
- Teva Pharmaceuticals (Parsippany, NJ)
- …key documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director will provide input to the ... Director Clinical Development - Oncology Date: Dec 9,...working closely with other functional areas such as commercial, regulatory , pharmacovigilance, CMC, and pre-clinical development in this regard.… 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
- Merck (West Point, PA)
- …sites, clinical safety and risk management to uphold the highest quality standards. The Senior Director and department will partner closely with ... mitigate potential risks associated with technical transfer programs, ensuring that patient safety and product quality are upheld throughout the transfer… 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
- Merck (West Point, PA)
- …includes marketing, product planning/project managing, formulation development, clinical, safety , regulatory , purchasing, manufacturing, packaging and labeling. ... **Job Description** The Director , Human Factors plays a pivotal role in...factors activities to ensure compliance with US and global regulatory policies/guidance for all combination products and medical devices… more
- Gentiva (Trevose, PA)
- …lives every day. **Overview** We have an exciting and rewarding opening for an **Executive Director - RN** to join our team in Trevose PA! Join us and find new ... 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