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TravelNurseSource is working with Cynet Health to find a qualified CVOR RN in Redding, California, 96001!. Job Specialty: Cardiovascular Operating Room (CVOR). Experience: Surgery RN CVOR experience required. Certifications: Advanced Cardiovascular Life Support (ACLS), Basic Life Support (BLS), DCI/BVP. Matching talented nurses like you with high-paying travel jobs at the best facilities across all 50 states.
Onsite for first day, then becomes fully remote. Handle inbound calls, chats, and emails regarding health plan and pension benefit inquiries.. Handle confidential information with sensitivity and discretion in accordance with HIPAA and Data Privacy laws and company data security requirements. Monday through Friday, 40 hours per week, No Weekends. Healthcare, call center, mail order medications, Insurance Verification, Medicare, Medicaid, Medical billing, EOB, Benefit, Patient Service, PBM, Enrollment, Provider Services, Pharmacy, prior authorization, reimbursement counselor, Medical customer service, inbound calls, outbound calls, answer phones, make calls, medical terminology, medical office, medical claims, healthcare claims, claims processing
The Moores Cancer Center (MCC) is one of just 53 NCI-designated Comprehensive Cancer Centers in the United States and the only one in San Diego County.. The Clinical Trials Office (CTO) at UCSD's Moores Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators.. Reporting directly to the Executive Administrative Director (EAD) of the Moores Cancer Center Clinical Trials Office (CTO), the Manager, Regulatory Affairs leads a team of Regulatory Coordinators while taking on more programmatic responsibilities.. Acting as a crucial link between the MCC CTO and various stakeholders, the Regulatory Manager serves as a liaison with both the Institutional Review Board (local and commercial) and ancillary committees.. Lead the CTO Regulatory Affairs unit to support compliant study activation and management of active clinical trials managed by the CTO. Apply extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity.
This position, Associate Director Regulatory Affairs , works out of our San Diego, CA location in the Infectious Diseases Division. This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs. Approve regulatory filing strategies based on proposed preclinical, clinical, and manufacturing changes. Bachelor's degree, preferably in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. 7+ years' experience in a regulated industry, +7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.. As a Scientist you will provide hands-on laboratory assistance to support pre-formulation, materials science, and compounding activities for small molecule, peptide, and antibody drug development projects.. Assist in studies such as solubility, characterization, and preclinical formulation development to support selection and optimization of developable candidates along with other pre-formulation/characterization studies.. Familiarity with the development and execution of chemical and instrumental methods (e.g. HPLC, Solubility Analysis, DSC, TGA, PXRD, Particle-Size Analysis, GVS, PLM, T3, and SEM) of analyses for development compounds, drug substances, raw materials, intermediates, drug products, and packaging materials.. The hourly pay range estimated for this position Specialist II, Clinical Lab Scientist based inCalifornia is –.
The Regulatory Affairs Manager (RA Manager) will manage, evaluate, and complete regulatory projects consistent with company goals.. Represents Regulatory in cross-functional teams and provide guidance to teams on the regulatory requirements and risk(s) to support clinical development programs including preparation and maintenance of e.g., IND, CTA, and IMPD filings.. Collaboratively develop global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs.. Bachelor's degree in scientific discipline with 2-5 years pharmaceutical industry experience, including 2+ years in Regulatory Affairs.. Working knowledge of GMP, GLP, and GCP regulations as well as an understanding of the pharmaceutical product life cycle.
Radionetics Oncology is supported by Frazier Life Sciences, 5AM Ventures, DCVC Bio, Crinetics Pharmaceuticals, and GordonMD Global Investments and has entered into a strategic agreement with Eli Lilly.. The Senior or Executive Director, Program Leadership and Regulatory Operations is an experienced individual contributor and professional leading strategic program management company-wide.. Reporting to the SVP of Regulatory Affairs, Clinical Pharmacology & Nonclinical Development, this individual has overall responsibility for the coordination of program leadership, regulatory operations and other projects across programs.. The Senior or Executive Director, Program Leadership and Regulatory Operations is critical for the strategic planning, execution, and delivery of overall program goals including regulatory goals, ensuring alignment with company objectives and regulatory requirements for oncology radiopharmaceuticals.. Follow-up with CROs on contracted nonclinical development and clinical bioanalytical, PK, metabolism, transporter, etc.
The Chief Medical Officer, CMO will work as a strategic partner with other members of the senior executive team to develop and advance their clinical development strategy and drive the clinical research vision and regulatory roadmap for the company.. The CMO will have over-arching responsibility for the successful clinical development of the Companys pipeline programs and will be the external face of the company for clinical research and development opportunities, interacting with principal investigators, key opinion leaders, and potential pharmaceutical partners.. Actively assist in seeking product and/or technology alliances with appropriate pharmaceutical company partners to enhance/expedite the development of the companys assets.. Board Certified MD/PhD, or MD with medical research and drug development experience.. Prior experience in leading interactions with the FDA and knowledge of FDA/EMA GCP clinical requirements.
BioPhase is partnering with a cutting-edge biotech company to hire a Chief Medical Officer (CMO).. The CMO will drive clinical trial execution, collaborate with investigators and partners, and ensure alignment with business objectives.. Oversee clinical operations, medical monitoring, and regulatory affairs.. MD, MD / PhD with strong drug development experience.. 10+ years in biotech / pharma, with oncology experience preferred.
This position, Associate Director Regulatory Affairs , works out of our San Diego, CA location in the Infectious Diseases Division.. This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs.. Approve regulatory filing strategies based on proposed preclinical, clinical, and manufacturing changes.. Bachelor's degree, preferably in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.. 7+ years' experience in a regulated industry, +7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
We are a dynamic and innovative Cardiac Cath Lab Ambulatory Surgery Center, proudly accredited by AAAASF and committed to delivering the highest quality patient care.. Assistant Director of Nursing (ADON) Kearny Mesa. Assistant Director of Nursing (ADON) Arbor Hills. LVN Resident Services Director/ Assisted Living DON. Clinical Nursing Supervisor (RN) - Behavioral Health
The Moores Cancer Center (MCC) is one of just 53 NCI-designated Comprehensive Cancer Centers in the United States and the only one in San Diego County.. The Clinical Trials Office (CTO) at UCSD's Moores Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators.. Reporting directly to the Executive Administrative Director (EAD) of the Moores Cancer Center Clinical Trials Office (CTO), the Manager, Regulatory Affairs leads a team of Regulatory Coordinators while taking on more programmatic responsibilities.. Acting as a crucial link between the MCC CTO and various stakeholders, the Regulatory Manager serves as a liaison with both the Institutional Review Board (local and commercial) and ancillary committees.. Lead the CTO Regulatory Affairs unit to support compliant study activation and management of active clinical trials managed by the CTO. Apply extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity.
Coordinates global CMC regulatory activities necessary to conduct clinical trials, achieve marketing approval of drug candidates and ultimately support the life-cycle of approved products. Supports CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements. Supports the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing/mitigating regulatory risks. Targeting at least 8 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development. Previous experience in the preparation and submission of the CMC components of IND/CTA and NDA and ex-US MAA submissions.
Join Bristol Myers Squibb as a Clinical Development Program Lead, Neuropsychiatry (Executive Director).. Position Summary : The Clinical Development Program Leader oversees the design and execution of clinical trials, manages teams of clinical professionals, and contributes to strategic planning and regulatory submissions.. Qualifications & Experience : MD or equivalent, with over 10 years of clinical trial and drug development experience, including management and regulatory expertise.. Additional Details : The role requires domestic and international travel, offers competitive compensation, and benefits aligned with industry standards.. The work environment emphasizes diversity, inclusion, and work-life balance.
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and quality standards. Support preparation of internal quality and regulatory documents in support of regulatory submission (De Novo and 510K) for IVD products. 3+ years of experience in regulatory affairs, quality assurance, or compliance within the medical device or In Vitro Diagnostics industry.
Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.. Catalent Pharma Solutions in Kansas City, MO is hiring a Supplier Quality Assurance Senior Specialist.. Complete Supplier Quality Agreements, Supplier Audits, (questionnaire and site), Risk Assessments, Risk Control Plans, License Review, Change Controls, Actions and Follow-up’s. Experience and sound knowledge of GMP/GDP/GCP regulations, especially those related to comparator sourcing, wholesaler licensing, third party storage and distribution preferred. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.
SUMMARY : We are seeking a Sr Clinical Research Coordinator to join ACN and lead our clinical operations team at our San Diego location.. Partner with Regional Site Director to ensure compliance and productivity of all clinical site staff and operations.. Manage all required study start up documentation, training and timelines on assigned study protocols.. 2+ years’ experience working as a Clinical Research Coordinator, preferred.. Create a job alert for this search Clinical Research Coordinator
Current UC San Diego Health CNA (NX) represented RN/NP applicants will be considered after the first 7 days of job posting.. Operational and Clinical resources include coordinators, nurses, project managers, regulatory support, phase I unit, infusion center, pharmacy, DEXA scans, cardiac phenotyping, exercise physiology, and additional clinical services.. Under the direction of the Nursing Supervisor, serve as a Clinical Research Nurse and provides primary nursing to pediatric and adult volunteers in a clinical research unit, including but not limited to, drug administration, infusions, assisting with biopsies, glucose tolerance testing, monitoring vital signs, IV insertions and phlebotomy.. Ability to understand clinical research protocols and carry out specialized clinical research procedures such aspharmacokinetic sampling, gene therapy, chemotherapy.. PREFERRED QUALIFICATIONS Certification as a clinical research coordinator.
Responsible for leading and developing drug supply planning strategy and overall management of all aspects of drug supplies (IP) for global Phase I - III clinical studies as the leader of Investigational Medicinal Supply Chain (IMSC). Coordinate drug supply delivery timelines with Clinical and CMC; Packaging, Labeling, and Distribution CRO's; and indirectly with GMP manufacturers, QA, and Regulatory Affairs,.. Support financial planning for global clinical supplies, including budgeting, forecasting, and strategic planning activities for clinical trials; and reconciliation of drug distribution invoices with finance staff to maximize productivity, efficiency, and overall business performance. Fundamental knowledge of inventory management and forecasting systems, IVR systems, and Clinical Trial Supply processes is required. Collaborates with Quality Assurance, cGMP and cGCP Compliance Specialists and Subject Matter Experts, and maintains a strong understanding of Global Health Authority regulations for packaging, labeling, systems, distribution, and vendor management is required.
Lead the development of clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submission documents.. Collaborate with cross-functional teams, including clinical research, regulatory affairs, biostatistics, and project management, to gather and interpret complex scientific data.. A minimum of 8-10 years of experience in medical writing within the pharmaceutical, biotechnology, or medical communications industries.. Exceptional writing, editing, and communication skills, with a keen attention to detail.. Proficiency in Microsoft Office Suite and familiarity with document management systems.