Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution wh
Coordinate and collaborate regulatory activities across functions within ORIC, ie, regulatory operations, quality, CMC, nonclinical, clinical. The position is responsible for supporting and leading activities within the Regulatory Affairs department, to support clinical development of oncology produ
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
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
Integrates scientific, clinical, safety, and commercial considerations to build cohesive regulatory roadmaps from first-in-human through post-marketing lifecycle management. The Executive Director, Regulatory Strategy – Endocrinology is a senior regulatory leader responsible for shaping and drivin
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
Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience; other relevant medical affairs experience may be considered. Documents include review of specific clinical, regulatory, and scientific documents including protocols, informed consent/assent forms,
The position provides direct patient care that regularly involves heavy lifting and moving of patients and assisting with ambulation. Observe patient and conduct machine safety checks according to facility policy. Assist other health care members in providing patient specific detailed education rega
Clinical judgment and decision making Utilizes the nursing process and a critical thinking approach to provide patient care that incorporates the mind, body and spirit; is individualized, goal directed, and consistent with current standards of safety. Independently performs the nursing process throu
Complies with hospital policy in management of patients in restraints. Uses proper body mechanics and safe patient mobilization equipment to ensure patient's safety and avoid personal injury. Collaborates with the interprofessional team in the delivery of quality patient/resident care under the dire
Participate in the development of medication use management programs within Sharp Healthcare including clinical guidelines, critical pathways, disease management, and drug use programs. Research and teaching responsibilitiesTake a leadership role in clinical research and the teaching programs of the
Clinical judgment and decision makingUtilizes the nursing process and a critical thinking approach to provide patient care that incorporates the mind, body and spirit; is individualized, goal directed, and consistent with current standards of safety. Independently performs the nursing process throug
Collaborates closely with, providing oversight as needed to, the Clinical Manager/Charge RN acting as nurse manager, the Medical Director, and the physicians regarding the direct patient care responsibilities within the facility to ensure the provision of outstanding quality of patient care, as defi
Regulatory complianceLabels/stores, ensures safety of patient's belongings (hearing aids, glasses, dentures). SafetyConsistently utilizes proper body mechanics and available support equipment to ensure patient's safety and avoid personal injury. Complies with hospital policy in management of patient
The position provides direct patient care that regularly involves heavy lifting and moving of patients, and assisting with ambulation. Provides patient care under the supervision of the FKC RN for assigned patient (s) in the acute setting. Performs and document any intervention for unusual patient s
Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Perform site monitoring visits (selecti
Independently performs the nursing process through individualized assessment, planning, implementation and evaluation of safe, therapeutic, efficient care for patients with overt and subtle needs throughout the continuum of care, and according to unit's standards of care. Clinical judgment and decis
Works collaboratively with their department of medicine specialty and any Inpatient unit, with the exception of patients defined as Critical Care (NICU, PICU, CTICU) and under the care of an Intensive Care Unit (ICU)-credentialed physician. The Nurse Practitioner, Acute Care may provide consultation
Under the direction of PFS Leadership, the Reimbursement Specialist I is responsible for billing and collections of outstanding account balances for commercial, government, and managed care payors as assigned. This position expects the Reimbursement Specialist I to demonstrate organization and time
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