- Novo Nordisk Inc. (Plainsboro, NJ)
- …role of GxP Patient Safety, Compliance & Vendor Oversight within our Clinical , Medical & Regulatory (CMR) organization. This position combines the critical ... About the Department The Clinical , Medical and Regulatory (CMR) department...vendor partnerships. Relationship This job reports to the Senior Director of the GxP Compliance & Technical… more
- Merck & Co. (Upper Gwynedd, PA)
- …in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and Assist the Executive Director /AVP in ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will...of Action and Milestones (POA&M), Regulatory Affairs Compliance , Regulatory Compliance {+ 5… more
- Merck & Co. (North Wales, PA)
- …to ensure GRACS contractual obligations and commitments are met while maintaining regulatory compliance . - Work closely with the Corporate Business Development, ... Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory Compliance , Regulatory … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Boston, MA)
- …monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre- clinical and ... in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Executive Director and/or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Safety/Quality/Training processes, systems, and resources are optimized to support regulatory compliance while enabling scalability, automation, and continuous ... About the Department The Clinical , Medical and Regulatory (CMR) department...to make a difference? The Position The Patient Safety, Compliance & GxP Operational Excellence Lead is responsible for… more
- Unknown (Wichita, KS)
- … clinical operations, including business development, financial control, and ensuring compliance with all regulatory standards. This role demands a hands-on ... particularly in the areas of operations, growth strategy, and clinical leadership oversight. The Executive Director will...strategy, and clinical leadership oversight. The Executive Director will also be tasked with managing a large… more
- Unknown (Wichita, KS)
- …and clinical operations, business development, financial control, and ensuring compliance with all regulatory standards. This role demands a hands-on ... particularly in operations management, growth strategy, and oversight of clinical leadership. The Executive Director will also...and oversight of clinical leadership. The Executive Director will also be tasked with managing a large… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...the regional regulatory strategy, objectives, policies, and programs pertaining to developing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal workflows and performance metrics to ensure departmental KPIs and regulatory compliance are consistently met Implement Medical Review Prospective ... About the Department The Clinical , Medical and Regulatory (CMR) department...you ready to make a difference? The Position The Director Medical Review oversees a team of Medical Reviewers… 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 ... areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the...therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC, clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Ensures timely execution and follow-up. ... for patient support field teams. This role will oversee program operations, compliance , vendor contracts and relationship management. AD will drive collaboration and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Monitor internal workflows and performance metrics to ensure departmental KPIs and regulatory compliance are consistently met Audit & Inspection Readiness ... About the Department The Clinical , Medical and Regulatory (CMR) department...relationships within Intake and Triage, Medical Review, Submissions and Compliance , Global Safety, and centralized teams (eg, Training and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customers. Relationships This position reports into a Vice President or Sr. Director within the National Account Market Access Teams. Internally, this position has ... Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs, and Legal & Compliance . External relationships include Customers as outlined in the Purpose of… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …target product profile (TPP) development, due diligence projects, and clinical - regulatory compliance . ResponsibilitiesEssential Duties and Responsibilities ... and execute clinical trials for respiratory products, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to develop… more
- Eisai, Inc (Nutley, NJ)
- …15 or more years significant clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in ... and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) and for assuring the compliance of projects, products… more
- Merck & Co. (Rahway, NJ)
- …applicable laboratory testing regulations.Experience ensuring compliance of a clinical laboratory with regulatory standards.Experience with the development ... clinical implementation and advancing digital pathology within our company's clinical therapeutic pipeline.The Principal Scientist ( Director ) will have the… more
- Insmed Incorporated (NJ)
- … regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working with ... meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings. Keep abreast of all… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …guiding toxicology strategy from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in… more
