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ORIC Pharmaceuticals is seeking a Director/Associate Director in Regulatory Affairs to support clinical development of oncology products. This role requires at least 8 years of regulatory affairs experience and excellent communication skills. The successful candidate will support regulatory submissi
Coordinate and collaborate regulatory activities across functions within ORIC, ie, regulatory operations, quality, CMC, nonclinical, clinical. Excellent writing and editorial skills, ability to collaborate on development of high‑quality clinical‑regulatory documents, eg, investigator brochures,
Responsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus
The Executive Director, Regulatory Strategy – Endocrinology is a senior regulatory leader responsible for shaping and driving global regulatory strategy across Company’s Endocrinology pipeline, spanning early development through commercialization. Partners closely with Clinical Development, Safe
The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals. This role will create best
We are seeking a highly motivated individual to join as an Associate Director, Development Quality Assurance. A bachelor’s degree with a minimum of 12 years of GCP quality assurance experience, a master’s degree with a minimum of 8 years of relevant experience, a PhD with a minimum of 5 years of
Deep clinical domain knowledge including understanding of clinical workflows, medical terminology, and healthcare delivery processes. Clinical Concept Mapping: Translate complex clinical concepts and workflows into explicit data element mappings across diverse source systems, ensuring semantic accur
Jobboard is seeking an Associate Director of Regulatory Affairs to provide regulatory support for medical device systems at our San Diego site. The ideal candidate will have over 10 years of experience in the Medical Device industry and at least 5 years in Regulatory Affairs. This role involves deve
Ensure continued regulatory compliance of products through adherence to the change control procedures, regulatory information management procedures and completion of regulatory impact assessments for assigned commercial and development products. The Senior Manager, Regulatory Affairs Global CMC will
Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. Escalate quality issues as appropriate. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Clinical/Medical Lab Scientists. Clinical/Medical Lab Scientists are highly skilled scientists who discover the presence or absence of disease and provide data that help physicians determine the best treatment for the patient. Clinical/Medical Lab Scientist generally work in a lab setting.
Masters or doctoral prepared nurse with Clinical Nurse Specialist Certificate who applies clinical expertise in evidence-based nursing practice within three spheres of influence; 1) patient/client, 2) nurses/nursing practice, and 3) organization/system in the following roles: clinical expert, educat
Clinical Informatics/Medical Records Consultant. The Medical Records Consultant assumes authority and accountability for the standardization, integrity, and compliance of medical records practices across multiple skilled nursing facilities. Collaborate with clinical informatics to optimize EHR usage
This role will communicate with patients and performs clinical services to ensure high quality patient care in a fast-paced environment. Performs clinical procedures such as blood draws, vaccines, nebulizer treatments, ear lavages, and EKGs. Utilizes electronic health records to order, process and d
Regulatory Affairs, Licensing and Accreditation Supports multi?hospital regulatory readiness and ongoing compliance with Joint Commission, CDPH, CMS, and other applicable regulatory and accreditation agencies. The Senior Specialist works collaboratively with operational leaders, quality, patient saf
We are seeking a highly motivated individual to join as an Associate Director, Development Quality Assurance. This individual actively leverages audit / inspection outcomes / trends to affect improvement in clinical trial quality and compliance with Ionis and global regulatory requirements. Thorough
Project Manager, Regulatory Affairs (Clinical and CMC). Join our team as a Project Manager in Regulatory Affairs, focusing on Clinical and CMC. Proficiency in project management and regulatory systems is essential.
Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team. The Clinical Development Medical Executive Director will be responsible for defining and executing on the development strateg
Regulatory Affairs, Licensing and Accreditation Supports multi?hospital regulatory readiness and ongoing compliance with Joint Commission, CDPH, CMS, and other applicable regulatory and accreditation agencies. Years experience in performance improvement, quality, patient safety, regulatory affairs,
Lead the development and execution of clinical development strategies for obesity and metabolic disease programs across multiple stages of development. Lead preparation, review, and contribution to key regulatory documents, including IND submissions, investigator brochures, clinical study reports, a