- Parexel (Augusta, ME)
- …this is the ideal role.** We're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior ... - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/ Clinical Trial Design, Clinical Strategy,… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …**It's Work That Matters.** **Overview** **Purpose Statement/Position Summary:** The Manager, Clinical Research Regulatory Affairs is tasked with oversight and ... personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments...governance of Regulatory Affairs department and involved in the day-to-day support… more
- Seattle Children's (Seattle, WA)
- …and leadership to the Seattle Children's Research Institute in quality analysis and regulatory support for clinical research. Leads overall business planning and ... set QA policies and standards that support the achievement of high-quality clinical research for our patients and families. Responsible for establishing and… more
- Insmed Incorporated (NJ)
- …maintenance, to ensure robust supply tracking and randomization supportCollaborate with CMC, Clinical Ops, Quality, Regulatory , and Commercial Supply teams to ... a high performing team across all levelsExperience in multi-functional areas ( Clinical , Regulatory , Quality) demonstrating a broad understanding of… more
- GRAIL (Atlanta, GA)
- …Qualifications:** + **Experience** + Minimum of 10 years of experience in regulatory , development, clinical affairs, quality, or program management within the ... Affairs Certification (RAC) preferred. + Experience in pharmaceutical clinical , statistical, or regulatory settings-especially in oncology, immunology,… more
- Merck & Co. (Rahway, NJ)
- …and key strategic engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage ... Job DescriptionOphthalmology Clinical Scientist:Job SummaryThis position leads the scientific planning and execution of one or more clinical trials or… more
- Lundbeck (Deerfield, IL)
- …active marketed products, by collaborating with cross functional teams during clinical development, regulatory submission and launch. + Supports Lundbeck ... Director US Regulatory Global Strategic Labelling Requisition ID: 7137 Location:...in the greater United States** **SUMMARY:** The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee… more
- Formation Bio (New York, NY)
- …for programs and clinical studies. Collaborate with cross-functional teams ( Clinical Development, Regulatory , Program Management, etc.) to shape and refine ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other ... around rare diseases and immune disorders. Summary: The Senior Director, Clinical Safety, will lead the development and implementation of integrated project/product… more
- GRAIL (Menlo Park, CA)
- …+ Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements + Working experience with an electronic data capture ... with study protocols, plans, SOPs, GCP/ICH, and all applicable regulatory requirements. + Manages all clinical operational aspects of a clinical trial from… more
- Bayer (Whippany, NJ)
- …of key documents (eg, Clinical Study Protocol, Investigator Brochure, Clinical Study Report, regulatory documents, etc.);Develop and oversee clinical ... to make a real difference, there’s only one choice. Sr Director, Global Clinical Lead, Diagnostic Molecular Imaging The Senior Director, Global Clinical Lead… more
- Seattle Children's (Seattle, WA)
- … Trial Operations will partner with investigators/sponsors as well as the core clinical , regulatory , data science, research and manufacturing teams to deliver ... We are seeking a detail oriented and strategic Clinical Trial Operations Director to oversee clinical...strategic Clinical Trial Operations Director to oversee clinical study operations within our healthcare organization. The successful… more
- Organon & Co. (Plymouth Meeting, PA)
- …expertise and development strategy. Additionally, cross-functional interactions with early clinical development, late- clinical development, regulatory ... regulators, scientific leaders, and physicians, as needed. + Oversight and/or review non- clinical CTD modules, briefing books, or other regulatory communications… more
- Insmed Incorporated (NJ)
- …clinical studies, reviewing & interpreting clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of ... clinical development team, partnering closely with heads of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical… more
- BeOne Medicines (Emeryville, CA)
- …models that strengthen representative patient enrollment. This role collaborates across Clinical Operations, Regulatory , Development, and corporate functions to ... and consistency over time. + Work actively and directly with the Clinical Operations, Regulatory , Clinical Development, and Human Resources to support their… more
- Organon & Co. (Plymouth Meeting, PA)
- …collaboratively with cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and ... Investigator Brochures, briefing books, IND subsections, submission modules and other regulatory documents. + Provide clinical pharmacology subject matter… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …of care delivery within the Transplant Service to include but not limited to clinical , regulatory , compliance, and quality of care. The position has matrixed ... care that is personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments that are a… more
- BeOne Medicines (San Mateo, CA)
- …Study Teams (CST) and provide a high service level to internal stakeholders (eg Clinical Operations, Regulatory , Quality, CMC). + Work with Clinical ... + Coordinate review and approval of labels with stakeholders (eg Regulatory , Clinical Operations, CRO) and CMOs. + Support IRT user acceptance testing,… more
- BeOne Medicines (San Mateo, CA)
- …Study Teams (CST) and provide a high service level to internal stakeholders (eg Clinical Operations, Regulatory , Quality, CMC). + Work with Clinical ... + May coordinate review and approval of labels with stakeholders (eg Regulatory , Clinical Operations, CRO) and CMOs. + Support IRT user acceptance testing,… more
- Caris Life Sciences (Phoenix, AZ)
- …yourself, Caris is where your impact begins.** **Position Summary** A Clinical Research Coordinator -Biorepository provides operational and regulatory support ... + 3-5 years' experience + Candidates should have experience with clinical trial regulatory documentation or TMF. + Candidates should have a strong understanding… more
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