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The Patient Care Coordinator serves as the first point of contact for patients, families, and referral sources.. This role is vital in ensuring a seamless patient experience—from scheduling and insurance coordination to supporting clinicians with documentation and follow-up care.. Greet patients and manage front office reception duties in a welcoming, professional manner.. Handle patient care plans, scheduling, and prosthetic device orders.. Experience in healthcare administration, patient coordination, or medical office setting (prosthetics/orthotics experience a plus).
We are seeking an experienced and highly motivated Director of Regulatory Affairs, Medical Writing, and Quality Assurance to lead our regulatory strategy, medical writing initiatives, and quality assurance processes.. Mentor and develop the regulatory, medical writing, and QA teams, fostering a culture of excellence, accountability, and continuous improvement.. Manage audits and inspections, ensuring preparedness and compliance with regulatory standards.. 5+ years of experience in regulatory affairs, medical writing, and quality assurance within the pharmaceutical or biotechnology industry.. Get notified about new Director of Regulatory Affairs jobs in San Diego, CA
Founded in 1997 and built upon 25+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval.. The RAM will also assist in developing regulatory strategies for both internal and external Sponsored projects and act as liaison between FDA and the Sponsor.. Assisting or acting as the primary writer of regulatory content included as part of a regulatory submission or application.. Planning, compiling, publishing and submitting Regulatory documents for INDs and NDAs, including Amendments, Supplements, and Meeting materials to the FDA. Occasional support related to BLA, IDE, and PMA applications may be required.. Please note the candidate must be currently residing in San Diego, CA or willing to relocate.
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.
Further, the Vice President, Regulatory Affairs & Quality Assurance, is responsible for building and mentoring a high-performing team while assuring that ORIC is compliant with federal and state legislation, health authority regulations and guidances, and driving a culture of quality and accountability across the organization.. Provide oversight for global regulatory affairs in all major regions (North America, Europe, Asia Pacific, Latin America) for all regulatory functions, including Clinical, Non-clinical, Regulatory Operations, and broad oversight for Regulatory CMC and Regulatory Diagnostics. Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA/PMA) in compliance with all applicable regulatory requirements, and in alignment with corporate goals. Demonstrated success leading major regulatory submissions (NDA/BLA/MAA) through approval. Strong experience with GXP compliance and building quality systems (QMS) in a development-stage and/or commercial environment
( *in collaboration with AbbVie ). The role involves working with cross-functional teams (clinical project managers, pharmacology, biometrics, regulatory, drug safety) to create and execute development plans that will lead to product approvals.. The role includes providing expert medical advice to navigate complex drug development and working closely with Research and Preclinical Development to develop biomarkers for early clinical evaluation.. Deep knowledge of drug development, regulatory issues, and clinical research processes.. Strong knowledge of GCP, regulatory procedures, translational medicine, and biomarker evaluation.
Specific responsibilities will include: being the clinical or program lead for the development of clinical research strategies, clinical development plans, and independent direction of Phase 1-4 clinical studies collaboratively within cross-functional project teams (including clinical operations, preclinical/clinical pharmacology, biometrics, regulatory, drug safety, CMC). Partners with Drug Safety Pharmacovigilance on adverse event reporting and safety monitoring committees as required. Contribute to publication and presentation of data through scientific communications externally.. MD or equivalent degree with accredited residency training and board certification in Neurology; subspecialization (Fellowship trained) preferred and 8+ years experience in clinical drug development (Phase 1-3) in a pharmaceutical/biotechnology company, including significant experience in senior leadership role.. Extensive knowledge of clinical drug development is mandatory, including knowledge of clinical development planning, US and global regulatory requirements and submission standards, study design, biostatistics, Good Clinical Practice (GCP), comfortable with oversight of internal and CRO resources in study conduct, data collection and analysis, report writing, and scientific presentation of data, across early and late development phases
Reproductive Partners San Diego is a leading Southern California fertility clinic, internationally and nationally recognized for our success in IVF in vitro fertilization, egg freezing and other fertility treatments for our patients.. The Financial Director is a key leadership role responsible for overseeing all aspects of Revenue Cycle Management (RCM) and financial operations within the organization.. Manage the practices accounting functions, including general ledger, accounts payable/receivable, and payroll.. Deep knowledge of medical billing, coding, insurance reimbursement, and healthcare compliance.. Technical Skills: Proficiency in RCM software, EHR systems, QuickBooks, and financial reporting tools.
The Director will work cross-functionally with R&D, Systems Engineering, IT-Cybersecurity, Human Factors, Regulatory Affairs, and other internal and external stakeholders to ensure seamless integration of digital products into broader system architectures.. Bachelors or Masters degree in Engineering, Computer Science, Biomedical Engineering, or related field.. 10+ years in software design quality assurance within the medical device or medical digital health industry.. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process.. Insulets flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller.
Looking for an experienced Regulatory & Quality Assurance Supervisor to help us maintain compliance and drive excellence in our QMS. This role is perfect for someone who thrives in dynamic environments and wants to make a direct impact on patient safety and product quality.. Serve as a key point of contact during FDA, ISO, and international audits. Manage and improve the Quality Management System (QMS), including internal audits, change control, and risk management. 5+ years of Regulatory Affairs and Quality Assurance experience in medical devices (preferably Spinal or Orthopedic experience). Regulatory Affairs Certification (RAC) preferred
Designed for retail clinics and private practices, our platform is currently undergoing FDA review and aims to revolutionize routine blood testing by making it more accessible, affordable, and actionable.. Truvian is seeking an experienced and hands-on Senior Regulatory Affairs Manager to lead and execute all aspects of the company’s global regulatory strategy.. Key Responsibilities Support the regulatory strategy for Truvian’s portfolio of IVD products, ensuring proactive planning and timely execution of submissions to FDA (510(k), CLIA Waiver), Health Canada, European Notified Bodies (CE Mark/IVDR), and other international agencies.. Required Qualifications Bachelor’s degree in Life Sciences, Engineering, or a related discipline required; advanced degree (MS, PhD, PharmD) strongly preferred.. Kombucha, cold brew, and healthy snacks are always on tap
The scope includes enhancing growth accelerators within the current CAP and Respiratory Care business domains and diversifying into alternative therapies, adjacent sleep disorders, and beyond.. This role requires the ability to oversee a broad portfolio of products, including those that may not be medical devices in all markets, understanding the nuance of such differences and providing the business with actionable strategies to support growth.. Qualifications & Experience Bachelor’s degree in biomedical engineering, regulatory affairs, life sciences, or related discipline.. Prior experience working with ResMed-type devices (CPAP, ventilators, masks, accessories).. Hands-on experience with submission platforms and document control tools (e.g., RIMSYS, Jira, Confluence).
As a Graduate Pharmacy Intern, you will leverage your academic knowledge from pharmacy school into real-world applications, gearing up for a Pharmacist role.. With guidance from your preceptor and District Leader, you will follow a comprehensive training roadmap within 120 days of graduation, aimed at expanding your understandings of store, district, and regional pharmacy operations.. This hands-on experience will enrich your insights into patient safety, error prevention, quality assurance drug utilization review (DUR), and pharmacy professional standards.. Ensure smooth pharmacy operations by adhering to workflow procedures for prescription fulfillment.. Must be a PharmD graduate of an accredited program before commencing the Post-Graduate Training Program at CVS Health.
MedInsight is a subsidiary of Milliman; a global, employee-owned consultancy providing actuarial consulting, retirement funding and healthcare financing, enterprise risk management and regulatory compliance, data analytics and business transformation as well as a range of other consulting and technology solutions.. As the Director, Government Programs - Medicare & Medicaid, you will lead the strategic expansion of MedInsight's footprint in the Medicare Advantage and Medicaid Managed Care sectors.. Serve as a thought leader on value-based care contracting, continuously assessing the evolving needs of government payers and adapting strategy accordingly.. Familiarity with Medicaid waiver programs, dual-eligible strategies, and state innovation models. Background in government affairs, regulatory strategy, or public health policy a plus
Ensure compliance with GCP, ICH, and FDA regulations throughout study conduct; proactively identify risks and implement corrective actions.. Coordinate cross-functional collaboration between clinical operations and internal departments and/or external resources such as data management, biostatistics, safety, regulatory affairs, QA, and medical writing.. KNOWLEDGE/SKILLS/ABILITIES Strong understanding of clinical research regulations and guidelines (GCP, ICH, FDA).. EDUCATION/EXPERIENCE PharmD preferably, or Master’s degree in a scientific or health-related field.. Unlimited PTO – based upon our trust of employees to manage their work schedule and mutual agreement between the employee and their manager.
The USC Keck School of Medicine - Alzheimers Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of scientific collaborators committed to advancing the development of new treatments for Alzheimers disease through innovative clinical trials.. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety.. Minimum Education: Bachelor's degree In Biological Science Or in related field(s) Addtional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 2 years in on-site clinical trial monitoring.. Preferred Education: Bachelor's degree And Master's degree In Neurosciences Or Public Health Or Pharmacology Or in related field(s) Preferred Certifications: Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).. Strong understanding of current GCP guidelines applicable to the clinical research conduct.
The USC Keck School of Medicine - Alzheimer’s Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of scientific collaborators committed to advancing the development of new treatments for Alzheimer’s disease through innovative clinical trials.. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety.. Minimum Education: Bachelor's degree In Biological Science Or in related field(s) Addtional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 2 years in on-site clinical trial monitoring.. Preferred Education: Bachelor's degree And Master's degree In Neurosciences Or Public Health Or Pharmacology Or in related field(s) Preferred Certifications: Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).. Strong understanding of current GCP guidelines applicable to the clinical research conduct.
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.
As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.. Essential Job Functions The Associate Director/Director of Clinical Pharmacology will be responsible for developing, driving, and implementing nonclinical and clinical ADME strategies.. You will be a core member of program teams providing ADME perspectives and delivering modeling and analyses necessary to evaluate nonclinical and clinical options, enable plans, and optimize development programs.. The successful candidate will bring extensive experience in nonclinical and clinical ADME with the ability to work cross-functionally with multifunctional teams to drive programs to success.. Job Requirements Ph. D. in Pharmacokinetics, Pharmaceutical Sciences, or a closely related discipline with 5+ years of experience for Associate Director or 8+ years of experience for Director in clinical pharmacology, modeling & simulation, drug metabolism and/or pharmacokinetics within a large pharma and / or biotech companies
The company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics, respectively).. Reporting to the Senior Vice President, Regulatory Affairs, the Senior Manager/Associate Director, Medical Writing will author, edit and provide input to documents required for regulatory submissions to US and other global health authorities, presentations, posters, publications and regulatory fulfillment.. Thorough knowledge of clinical research concepts, practices, and Food and Drug Administration (FDA)/European Medicines Agency (EMA)regulations and International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH)/Good Clinical Practices (GCPs) Guidelines regarding drug development phases, clinical research, and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing. A reasonable estimate of the base salary range for this role is $170,000-$179,000 for a Senior Manager and $179,000 – $187,000 for an Associate Director.. Medical Science Liaison, Wound Care, San Diego.