- 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
- 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
- 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
- Memorial Healthcare System (Hollywood, FL)
- …continuing education and curriculum related to clinical competencies, clinical equipment, policies and procedures, regulatory and accrediting.Designs, ... a rewarding experience for our employees involved in their care. Summary: The Clinical Educator of Imaging Services has expert level knowledge in the respective… 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
- Merck & Co. (North Wales, PA)
- …responsible for the business process and related activities associated with Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution. ... GRACS functional areas, to ensure implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements.-… more
- CHRISTUS Health (San Antonio, TX)
- …in the following area: unit specific orientation, skills/equipment training, clinical practice, and professional development. Evaluates effectiveness of staff ... impact on the quality of nursing care services. Utilizes clinical and staff development expertise to provide expert consultation...by state and federal agencies, the hospital, and other regulatory entities. Performs all duties in a manner that… more
- Merck & Co. (North Wales, PA)
- …for developing and executing integrated development plans that align clinical , medical affairs, commercial, manufacturing, regulatory , analytical, and ... or Public Health.Research background in the design and implementation of clinical studies, familiarity with biostatistics, and/or regulatory review process… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …toxicology strategy from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in ... scientific and strategic input to project teams across discovery, preclinical, regulatory , and clinical functions.Manage non-GLP and GLP-compliant studies… more
- Merck & Co. (Rahway, NJ)
- …and applicable laboratory testing regulations.Experience ensuring compliance of a clinical laboratory with regulatory standards.Experience with the development ... Molecular Biomarkers is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of … more
- Merck & Co. (Rahway, NJ)
- …and coach to the HF team and key stakeholders across R&D, clinical , regulatory , marketing, manufacturing, and quality functions.Educate and build awareness ... and represent the company externally to influence industry standards and regulatory practices.-Primary Scientific & Leadership Requirements - HF Influence Serve as… more
- Merck & Co. (Upper Gwynedd, PA)
- …and barriers to reimbursement and market access, and provides input into clinical , regulatory , payer/access, marketing and evidence generation strategies and ... resource utilization and costs, physician and patient satisfaction surveys, clinical and patient- reported outcomes assessments, systematic reviews and… more
- Merck & Co. (Rahway, NJ)
- …Respect - Inclusion.Design and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements by the ... primary function is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the... laboratory and field studies that will support the regulatory approval of new companion animal and livestock products.… more
- Insmed Incorporated (San Diego, CA)
- …collaborate closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs, and external partners.What You'll ... technical expertise and system documentation.Ensure data integrity, system reliability, and regulatory compliance across all phases of clinical development.Team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the programming standards and practices, SOPs, external/internal data standards, Good Clinical Practices (GCPs), applicable regulatory requirements, and other ... and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition and… more
- Insmed Incorporated (NJ)
- …CAPAs, change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory , Clinical Operations, and Program Management to drive ... is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, evolving pipelines.What You'll Do: Provide strategic and… more
- CHRISTUS Health (Alexandria, LA)
- …learning" to problem solve and personally reflect on decisions Clinical Performance Improvement Shares experiences with process performance improvements across ... new or innovative solutions Leverages technology to facilitate the sharing of clinical performance or outcomes data Compares and contrasts different approaches for… more
