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DelRicht is a clinical research company dedicated to providing an excellent customer experience to all patients that participate in our clinical trials.. Our clinical trials provide new treatment options for our patients and ultimately our goal is to get new medications and medical devices FDA approved!. Clinical Research Nurse's Main Objective: the Clinical Research Nurse is responsible for providing excellent patient care and a great experience for our patients in a clinical research setting.. Patient visits are completed accurately and efficiently; the Clinical Research Nurse is highly skilled in following written instruction, ensuring that all clinical trial protocols are adhered to 100% of the time. Annual Company Retreat with complimentary travel to New Orleans, Louisiana provided for all full-time team members
We are seeking a Sr. Research Nurse who will provide research coordination support for complex early phase clinical trials conducted in the Drug Development Unit (DDU) in the Division of Clinical Pharmacology. The Sr. Research Nurse will collaborate with the study's clinical team and faculty to implement multiple research protocols and will oversee study related activities. Oversees and supports study visits for non-licensed DDU staff (e.g. study coordinator, clinical research fellow). At the direction of the Clinical Pharmacology faculty, assists in ordering research doses of radioisotopes from a commercial radiopharmacy. Assist in monitoring the data integrity of studies assigned to other research nurse coordinators using Quality Assurance forms maintained by the DDU.
At CHOC, we strive to be the leading destination of children's health by providing exceptional and innovative care.. CHOC's compensation structure, benefits offerings, and career development programs are geared to helping you achieve your professional and personal goals.. The Coordinator of Regulatory Affairs assists with ensuring compliance with all relevant healthcare regulations and standards including the Joint Commission (TJC), the California Department of Public Health (CDPH), the Centers for Medicare and Medicaid Services (CMS), and other regulatory agencies for Children's Hospital of Orange County (CHOC) healthcare facilities including CHOC Orange and CHOC at Mission Hospital.. CHOC does not discriminate on the basis of age, race, color, religion, national origin, ancestry, marital status, genetic information, disability, sex, gender (including pregnancy, breastfeeding, childbirth, lactation or related medical conditions), gender identity or expression, medical condition, sexual orientation, veteran status, military or uniformed service member status, or other protected characteristics in accordance with state and federal laws.. CHOC will consider for employment qualified applicants with criminal histories, in accordance with the Fair Chance Initiative for Hiring.
We are seeking a highly skilled and motivated Clinical Research Nurse to join our team on a full-time basis, working Monday through Friday, day shift. As a Clinical Research Nurse, you will collaborate with a multidisciplinary team to coordinate clinical trials and provide exceptional patient care. These studies serve patients in specialties such as cardiology and CV surgery, pulmonology, transplant, neurology, GI, endocrinology, and infectious diseases. The research nurse position allows the team member to utilize their nursing knowledge and skills through the coordination of clinical trials. The clinical research nurse achieves this by coordinating regulatory aspects of clinical trials, collaborating with team members and key stake holders both within and outside of IU Health, screening and enrolling patients in clinical trials and carrying out study visits.
Located in the heart of downtown Grand Rapids, our cutting-edge global headquarters resides within the state-of-the-art Doug Meijer Medical Innovation Building.. The Clinical Trials Supervisor is responsible for overseeing the day-to-day clinical operations of research activities at their specified site to ensure every research visit, scan, and procedure is executed on time, per protocol, and with exceptional patient experience.. Quality Assurance: Ensure data accuracy and patient safety by following GCP and SOPs, partner with QA for audit readiness, and perform routine QC of eCRFs, regulatory binders, and investigational product logs.. Previous experience mentoring or supervising professional level staff, particularly in oncology or nuclear medicine, preferred. Experience with complex or early- phase trials (Phase I/II) in oncology, radiology, or nuclear medicine preferred
Lead and conduct domestic and global GCP audits (investigator sites, vendors, internal systems) for clinical trials across Phases I–IV.. Audit clinical trial systems and deliverables, including eCRF, databases, pharmacokinetics (PK), statistics (SAP, TLFs, datasets, CDISC packages), biostatistics, medical writing, pharmacovigilance, and data management outputs.. Collaborate cross-functionally with Clinical Operations, Data Management, Biostatistics, Pharmacovigilance, and Regulatory Affairs to resolve quality issues and implement improvements.. Quality Manager (Heavy Civil Construction) Des Plaines, IL $99,756.00-$149,633.00 2 weeks ago. Associate Director, Volunteer Communications & Marketing Project Director Workforce Supports (44053) We’re unlocking community knowledge in a new way.
This individual is a leader in the field of CPP, with integrated and deep understanding of drug development.. You will be responsible for providing, scientific leadership in a collaborative working environment to advance the drug candidates from IND through Phase IV.In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.. Develop and implement the CPP strategies across program, indication and study levels, including strategies for Phase I -III drug development.. Provide guidance in interpreting the data from pharmacometric analyses, including PPK, exposure-response analyses, and other quantitative analyses, to recommend dosing paradigm for different phases of clinical development; provide justification for dose selection for pivotal clinical trials.. Stay current with scientific advancements and regulatory trends in clinical pharmacology and Pharmacometrics, and apply the knowledge to advance drug discovery and development for the organization;
Join to apply for the Associate Director of Regulatory Affairs role at Alliance Clinical Network. SUMMARY: The Associate Director of Regulatory Affairs is responsible for managing the efficient execution of all regulatory functions across multiple clinical trials, providing strategic direction, resource allocation, and leadership to the regulatory team.. Legal Director - Technology Innovation Counsel. Director of eDiscovery and Litigation SupportVice President of Quality and Regulatory Affairs. Director Clinical and Regulatory Counsel - IrvingVP, Regulatory Intelligence & Compliance
Cardiosense's solutions are built on over a decade of clinical research and we continue to collaborate with the world's leading academic institutions to introduce the next generation of cardiac monitoring and disease management.. Work closely with data science and product teams to define clinical data requirements for AI model validation.. Minimum 8-10 years of experience in clinical research, with at least 5 years in a leadership role managing clinical trials, preferably in the medical device, digital health, or AI/healthcare sectors.. Proven experience designing and executing clinical studies, including model validation trials, for medical AI or digital health products.. Familiarity with AI model validation methodologies, particularly in healthcare applications.
Develop and implement regulatory strategies for medical devices, ensuring compliance with global regulations (FDA, EU MDR, Health Canada, TGA, etc. Advise on the appropriate regulatory pathways (e.g., 510(k), PMA, CE marking) based on device classification and target markets.. Support post-market surveillance activities, including adverse event reporting, vigilance reporting (e.g., MDR in Europe), and periodic reviews of product performance in the market.. Experience with international regulations (e.g., EU MDR, TGA, Health Canada) and global market access strategies.. In-depth knowledge of regulatory requirements for medical devices (FDA, EU MDR, Health Canada, etc
Senior Manager of Translational Pharmacology at Mirum, responsible for the General Pharmacology, Animal Efficacy, PK/PD, ADME, Bioanalytical, Translational Biomarker, and related studies required for further development and approval of Mirum rare disease assets.. Outsources nonclinical and bioanalytical studies, reviews resulting pharmacology and biomarker data, and reports to check for completeness and accuracy and communicate to teams. Provides CROs with technical oversight as needed and ensures that assay development, validations and data transfers occur at CROs and in-house to meet project goals. Previous experience with immunology of the liver and/or neurology preferred, especially in the context of rare disease. Deep knowledge of pharmacology and biomarker study design and interpretation, pharmacodynamics, and pharmacokinetics modeling
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders.. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.. Responsible for clinical trial transparency and disclosures, including clinical trials results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide, in collaboration with Regulatory Affairs. Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology.. Administrative Director - General Surgery, Colon & Rectal Surgery, Plastic SurgeryExecutive Director, NEBMA and Medical Staff ServicesExecutive Medical Director, Immunology Cell Therapy, Neuroinflammation, Multiple Sclerosis
Serve as the Regulatory Affairs lead on cross functional drug development teams, providing strategic input and guidance on global regulatory requirements.. 10+ years of regulatory affairs experience within the biopharma industry.. NDA and global marketing application experience highly desirable (e.g., MAA, NDS).. Industries Biotechnology Research and Pharmaceutical Manufacturing. Director, Global Regulatory Affairs, Neuroscience Associate Director, Global Regulatory Affairs - GI & Inflammation Boston, MA $153,600.00-$241,340.00 3 weeks ago
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.
Title: Regulatory Affairs Associate. Reporting to: Regulatory Affairs Manager. We are seeking a highly motivated and results-driven Regulatory Affairs Associate to join our dynamic sales team at Venus AI. You are responsible for supporting global registrations and ensuring that medical devices produced by Venus Concept meet all regulatory requirements for countries where the devices are marketed.. Venus Concept is an innovative global medical aesthetic technology leader with a broad product portfolio of minimally invasive and non-invasive medical aesthetic and hair restoration technologies and reach in over 60 countries and 10 direct markets.. Venus Concept's product portfolio consists of aesthetic device platforms, including Venus Versa, Venus Versa Pro, Venus Legacy, Venus Velocity, Venus Viva, Venus Glow, Venus Bliss, Venus Bliss MAX, Venus Epileve, Venus Viva MD and AI.ME. Venus Concept's hair restoration systems include NeoGraft and the ARTAS iX Robotic Hair Restoration system.
Join to apply for the Regulatory Affairs Manager role at Katalyst CRO. Sign in to set job alerts for “Regulatory Affairs Manager” roles.. Sr. Regulatory Affairs Specialist (Austin, TX) Associate Director, Regulatory Affairs Strategy Cambridge, MA $149,069.00-$223,604.00 3 weeks ago. Sr. Manager, Global Regulatory Publishing Manager, External and Regulatory Affairs Associate Director, Global Regulatory Affairs, Advertising and Promotion Boston, MA $153,600.00-$241,340.00 2 weeks ago. Associate Director CMC Regulatory Affairs We’re unlocking community knowledge in a new way.
Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.. Agios Pharmaceuticals is searching for a dynamic Associate Director, Regulatory Affairs Strategy to join our growing Regulatory team.. Sr Regulatory Affairs Specialist. Sr. Manager/Associate Director, Regulatory Affairs Strategy and Labeling. Senior Consultant - Regulatory Operations Software Implementation (Remote)Senior Consultant - Regulatory Operations Software Implementation (Remote)Associate Director, Global Labeling Devices
The preferred candidate will have expertise in multiple therapeutic areas, including metabolic diseases and obesity, and drug modalities and have led regulatory filings for IND and/or CTA opening studies.. Own the development of asset-specific Regulatory Development Plans, author and manage creation of IND/CTA & Briefing Books, drive pre-IND meetings and other Health Authority-facing interactions related to specific clinical trials.. Advanced degree (M.D., PhD, PharmD, MSc or MPH) with a focus in pharmaceutical sciences, including a minimum of 10 years of pharmaceutical/biotechnology industry experience in Regulatory Affairs lead role with hands-on regulatory experience in all aspects of regulatory affairs.. Prior experience in a combination of metabolic diseases and/or immunology drug development is ideal, and experience in rare diseases is a plus.. Experience with two or more of the following modalities is required: small molecules, biologics, peptides, nucleic acids, or cell therapies; with experience in novel modalities (e.g., gene editing, RNAi, gene therapy) desirable.
Senior Recruitment Consultant - CMC & Regulatory Affairs Director/Senior Director of Regulatory Affairs - Med Dev. As the Director of Regulatory Affairs , you will report directly to the SVP of Clinical and Regulatory Affairs and play a central role in shaping and delivering global regulatory strategy.. Proven track record with Class III device submissions, including PMAs, IDEs, and EU MDR/CE Mark approvals.. Experience supporting Notified Body interactions and post-market surveillance requirements.. Regulatory Affairs Specialist - Principal Specialist Regulatory Affairs Specialist - Medical Devices We’re unlocking community knowledge in a new way.
Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office. Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. On-Site: work five days per week on-site with ad hoc flexibility.