- Merck & Co. (Rahway, NJ)
- …responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes defining and optimizing ... GRACS, including training process standards and strategies to ensure optimal quality and compliance in GRACS business processes.Core Responsibilities may include and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will ... clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA...CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder minimal guidance of the Executive Director / Director /Associate Director , Pharmacovigilance (PV) Partner Strategy & Management (PV-PSM), ... partner and vendor PV agreements and leadership of the Global Clinical Safety & Pharmacovigilance (GCS&PV) implementation activities for partner deals including but… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the ... for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, internal company procedures and… more
- Merck & Co. (Rahway, NJ)
- …pipeline.This person will:Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and ... leveraging relationships within and across work groups of formulators, engineers, safety and quality representatives.Foster culture of collaboration, learning… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE).- Direct Project Support:… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro Delaware seeks to add an Attending Veterinarian in the role of ... DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets ... deviations.Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling regulations for products and filings. Manages… more
- Merck & Co. (NJ)
- …pharmaceutical; biopharmaceutical processing techniques and capabilities. Working knowledge of quality , safety and compliance requirements associated with ... that enables the commercialization of our medicines, vaccines and Animal Health products. We collaborate internationally and are grouped into center-led categories… more
- Merck & Co. (Rahway, NJ)
- …that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be ... talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and safety .NOTICE FOR INTERNAL… more
- Merck & Co. (Durham, NC)
- …human resource business partners, our Research Labs, our Manufacturing Division, Animal Health and Human Health on a regular basis.-Expected to independently ... with university partnerships and student recruitmentMonitor and report overall status and health of the partnership; identify areas of risk or opportunity to the… more
- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead ... the clinical development strategy and clinical protocols and delivering high quality clinical programs, from first-in-human trials, through to full development.Serve… more
- Novo Nordisk Inc. (Boulder, CO)
- …Boulder facility complies with all applicable environmental, health and safety regulations. Relationships Reports to the Associate Director , EHS. Internal ... observations to ensure compliance with regulatory agencies, company environmental, health , and safety policies, procedures and practices Maintain internal… more
- The George Washington University (Washington, DC)
- …also responsible for administrative oversight of the research radiation and laser safety programs. The Director , Regulatory Oversight works closely with Office ... and Compliance leadership, the Office of Clinical Research (OCR) staff, Environmental Health and Safety , Office of General Counsel, regulatory committee Chairs… more
- Benchmark Senior Living (Waltham, MA)
- …through the power of human connection by transforming the lives of seniors! The Director of Health and Infection Prevention Control partners with Resident Care, ... and Control Committee; participates in other assigned meetings such as the Quality and Safety Committees.Authority and responsibility for ensuring appropriate… more
- ContinueCARE Hospital at Palmetto Health Baptist (Columbia, SC)
- The Director of Quality facilitates, and manages the ongoing, hospital-wide Quality program to ensure compliance with accrediting and regulatory agencies. ... Develops, implements and manages Quality Improvement plans, policies, procedures, and programs. Gathers, disseminates,...Compliance Officer and Risk Manager Monitor compliance with the safety plans within the Environment of Care Management Program… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data governance processes ... including advocating for good data governance, stewardship, data identification, and data quality to enable business outcomes. This role will consist of these… more
- UT Health Tyler (Tyler, TX)
- … Health East Texas is advancing healthcare, together. POSITION SUMMARY The position of Quality and Patient Safety Director at UTHET is accountable for ... reporting across the division. Support the deployment and optimization of the electronic health record to maximize safety , quality outcomes, clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on 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 medicines for patients.… more
