Collecting information
Organizing data
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 –.
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.
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.
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.
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.
A San Diego healthcare organization is seeking to add a Medical Billing professional to their team. Knowledge of insurance guidelines, including HMO/PPO, Medicare, and state Medicaid.. A minimum of 2 years of Medical Billing experience in a fast-paced environment. Founded in 1990, Solomon Page is a specialty niche provider of staffing and executive search solutions across a wide array of functions and industries. The success of Solomon Page reflects an organic growth strategy supported by a highly entrepreneurial culture.
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
DESCRIPTION Under direction of assigned Principal Investigator (PI) and Project Manager (PM), the Clinical Research Coordinator III will independently coordinate and be accountable for the overall administration of clinical research efforts for a variety of advanced research projects and clinical trials.. The incumbent will be responsible for coordinating and monitoring clinical trials including providing all aspects of protocol oversight, including but not limited to screening for patient eligibility, consent review, data collection and analysis, ensuring protocol compliance, adverse drug/therapy reaction reports, monitoring patient treatment and toxicities, laboratory and specimen collection, processing, submission, and maintenance of accurate and complete clinical research files.. Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.. Knowledge of hematology/oncology or radiation oncology.. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care.
Implement systems and processes designed to ensure compliance with applicable laws, regulations, and standards (e.g., Department of Health and Human Services, including the Centers for Medicare and Medicaid Services (CMS) and the Office of the Inspector General (OIG. Review, monitor, and ensure compliance involving pharmacy and 340B requirements, including review of related reports and communication through assigned web portals.. Working knowledge of federal and state reimbursement program requirements (e.g., Medicare and Medi-Cal), federal and state anti-kickback and physician self-referral laws (e.g., Stark and PORA), and provider and practitioner licensure and scope of practice requirements, privacy, and consent laws.. Provide or coordinate annual trainings for staff regarding compliance such as HIPAA, Fraud Waste and Abuse, Fire and Safety.. Working knowledge of the Health Resources and Services Administration (HRSA) 330 Health Center Program requirements.
The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California, is an academic institute dedicated to advancing treatments for Alzheimer’s Disease (AD) through innovative clinical trials.. Collaborate with the Project Director and other teams to plan and manage all phases of multi-site clinical trials.. Bachelor’s degree in Biological Science or related field; experience can substitute for education.. Experience with medical devices, policies, GCP, and FDA guidelines.. Master’s degree in Neurosciences, Public Health, Pharmacology, or related fields.
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.
The individual will be responsible for providing education and support to trial team staff in the implementation of, and adherence to processes and workflows, controlled documents, tools, and templates to enhance the quality of study documents and the TMF. Incumbent will identify process improvement opportunities and will support process re-engineering.. Incumbent will contribute to the development of training materials while serving as a subject matter expert in both QA, QC and TMF. Incumbent will participate in the creation of a quality and education program through which staff involved in the conduct of clinical research, therapeutic and non-therapeutic protocols, will be educated and trained on current industry standards.. Act as subject matter expert and TMF point of contact for study teams and partners. Performs key TMF duties in accordance with established guidelines and work instructions (e.g., TMF set-up, management, completeness and timeliness monitoring, reports and metrics, closeout, and TMF quality control (QC) / quality assurance (QA) activities, etc.). Collaborate with study teams to ensure all appropriate documents have been filed prior to specific study milestones (e.g., site activation, amendments, close-out and TMF delivery) or according to contract requirements
Join to apply for the Biostatistician role at Philips. As a Biostatistician, you will conduct advanced statistical analyses to support clinical research studies, ensuring appropriate methodologies are used.. Perform complex statistical programming using software such as SAS or R, generate tables, listings, figures (TLFs), and prepare datasets for regulatory submissions.. You have a bachelor’s degree in Biostatistics or equivalent and 2+ years of experience in areas such as Biostatistics, Clinical Research Study Design, Statistical Programming and Analysis, MedTech, Healthcare Administration or equivalent OR no prior experience required with Master’s Degree.. Get notified about new Biostatistician jobs in San Diego, CA.
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.