- Parexel (Nashville, TN)
- …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
- Lupin Pharmaceuticals (Coral Springs, FL)
- …target product profile (TPP) development, due diligence projects, and clinical - regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities ... clinical trials for respiratory products, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to develop study protocols,… more
- Merck & Co. (Rahway, NJ)
- …for clinical supplies. Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...(GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Company's Research and… 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. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated… more
- Prolink (Cincinnati, OH)
- …a supervisory capacity and various healthcare settings ? Experience with leadership in clinical regulatory audits conducted by The Joint Commission, or similar ... Temporary Clinical Compliance Manager (2025-3186) job in Remote **Location:**...with Implementation for new engagements ? Oversee regulations and regulatory process to implement relevant client requirements and guide… more
- Teleflex (Minneapolis, MN)
- …projects as requested, including audits, investigator meetings, training, etc. o Interfaces with Clinical , Regulatory , Sales, and clinical site staff as ... Regional Clinical Research Associate (REMOTE) **Date:** Oct 10, 2025...as well as centralized monitoring in compliance with applicable regulatory standards (FDA regulations, ICH/GCP guidelines, Teleflex procedures, and… 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
- Organon & Co. (Plymouth Meeting, PA)
- …is expected to participate in cross-functional development programs with early clinical development, late- clinical development, regulatory affairs, safety ... This position will also be responsible for reviewing and authoring non- clinical and clinical modules for regulatory submissions, briefing books and other… 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
- Organon & Co. (Jersey City, NJ)
- …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
- Eisai, Inc (Nutley, NJ)
- …on clinical quality topics.Build and manage overall relationships with regulatory bodies to address emerging needs and issues.Manage and retain talent within ... 15 or more years significant clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance).Substantial experience in … more
- Caris Life Sciences (Phoenix, AZ)
- …yourself, Caris is where your impact begins.** **Position Summary** A Clinical Trial Specialist-Biorepository provides operational and regulatory support for ... + 3-5 years' experience + Candidates should have experience with clinical trial regulatory documentation or TMF. + Candidates should have a strong understanding… more
- Parexel (Concord, NH)
- …assigned programs from early development through approval - Coordinate cross-functional regulatory activities (CMC, nonclinical, clinical ) to meet key milestones ... biologics - Deep knowledge of FDA, ICH, and global regulatory frameworks - Experience with international clinical ...global regulatory frameworks - Experience with international clinical trials and regulatory documentation - Strong… more
- Parexel (Montpelier, VT)
- …deliverables + Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations + Experience in clinical research ... degree with a minimum 7 years of relevant operational clinical trial experience required + Master's of Science or...degree with a minimum 6 years of relevant operational clinical trial experience required + A scientific or technical… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …experiences, perspectives and backgrounds allow us to better serve our patients and create a strong community at CHLA. Clinical Research Regulatory Affairs ... 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
- Medalogix (Nashville, TN)
- …knowledge managing multiple agency locations to guide best practices around clinical operations practices, business operational processes, and regulatory ... services to support MLX internal and external information and guidance in clinical , operational, and regulatory matters to ensure compliance with applicable… more
- Insmed Incorporated (NJ)
- …and cross functional teams. This individual will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as ... future of science, we're in. Are you?About the Role:The Associate Director, Clinical Research Scientist will support and work predominately with the Medical Monitor… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …**Minimum Qualifications/Work Experience:** - Required: 3 years of experience in clinical research operations or regulatory or an equivalent combination ... 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
- Merck & Co. (Rahway, NJ)
- …design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase ... scientific principles and statistical methods applied to designing and analyzing clinical trials in support of worldwide regulatory submissions.This position… more
- Kenai Therapeutics (San Diego, CA)
- …clinical trials, with a focus on meeting project milestones, timelines, and regulatory requirements. The VP of Clinical Operations will collaborate closely ... leadership, including the CMO, to shape and execute the clinical development strategy, ensuring it meets regulatory ,...the clinical development strategy, ensuring it meets regulatory , scientific, and commercial needs. Clinical Trial… more
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