Responsible for the 24 hour management of the assigned unit assuring patient care meets the standard of care. SKILLS AND CERTIFICATIONS. . Graduate of an accredited school of Nursing, BSN required, MSN preferred. Minimum of five (5) years clinical experience required. Minimum of two (2) years progressive management experience required. Current RN license in the State of Nevada. Current BCLS Certification.
Employs Nursing Professional Practice: Assesses, identifies appropriate nursing diagnoses, plans, implements and evaluates patients’ care. Develops, updates and coordinates the patient’s plan of care to achieve patient goals and to optimize outcomes and transitions across the care continuum. Monitors, records and communicates patient condition as appropriate. Performs and maintains currency of essential competencies as required by specific area o...
Position. Summary. This. position will report into the Senior Director of Quality responsible for the. oversight and management of Quality Control (analytical and microbiological) at. the Clinical and Commercial sites. Responsible for managing the laboratories daily. activities and continuous improvement initiatives to ensure compliance and. client requirements are met. . Core. responsibilities include, but not limited to, management of resources...
The Director US Regulatory Affairs supports. the contract development and manufacturing of client cell therapy products for. the US market. This individual collaborates cross-functionally to. support client projects, including support for submissions, coordinating. pre-approval inspections, and managing compliant licensing for all facilities. supplying the US market. This individual also creates and maintains. systems by which regulatory document...
B. io-pharmaceutical company focused on the discovery and development of small-molecule immune modulators for the treatment of cancers, inflammation and autoimmune diseases, has an opening for a Principal Scientist at its Ann Arbor, Michigan site. The successful candidates will enjoy working in a fast paced, collaborative environment and be skilled at designing and conducting experiments, data presentation and leading/managing project teams to ac...
Summary. The Associate Director of Quality Assurance is responsible for. designing, planning, implementing, directing and evaluating a quality assurance. function and a quality management system which supports clinical development. and regulatory approval of products. This role requires extensive interaction. with Clinical Operations, Pharmaceutical Operations, Program and CMC project. management, Regulatory Affairs, Supply Chain, and CMOs. . Res...
Job Description. Summary. . The Manager of Quality Assurance is responsible for designing, planning, implementing, and evaluating a quality assurance function and a quality management system which supports clinical development and regulatory approval of products. This role requires extensive interaction with Clinical Operations, Pharmaceutical Operations, Program and CMC project management, Regulatory Affairs, Supply Chain, and CMOs. . Responsibi...
Summary. The Manager of Quality Assurance is responsible for designing. planning, implementing, and evaluating a quality assurance function and a. quality management system which supports clinical development and regulatory. approval of products. This role requires extensive interaction with Clinical. Operations, Pharmaceutical Operations, Program and CMC project management. Regulatory Affairs, Supply Chain, and CMOs. . Responsibilities. Develop,...
Overview. This position will predominantly have. regulatory accountability across all pharmaceutical development programs, will. manage internal regulatory processes, and will develop regulatory. capabilities/competencies within the business unit. Directs the regulatory. activities required to support product development activities and to achieve. marketing authorization for development programs. This position. ensures timely communication, feedb...
This position in CMC Regulatory Affairs involves the ability to support and provide some management to guide the Industrial Operations and Product Supply (IOPS) team in the decision-making process and strategic planning. This position also supports all CMC regulatory filing activities for various pre-INDs, INDs, IMPDs, CTAs and BLAs/MAAs and tracking of regulatory commitments. Job Duties. Essential Functions required for the job. List both techni...
This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of Company's quality, preclinical, and clinical drug development programs, policies, and procedures, so that development teams are able to meet all objectives within specified timelines and the necessary state of compliance is maintained relative to all regulatory commitments/requirem...
Summary. The growing need for EU-specific expertise on our development programs as well as to keep the company compliant on emerging EU legislation and processes has led to the need to create a new position based in our Dublin or Uxbridge office. The role is positioned at the Manager/Senior Manager level to enable advanced regulatory input to interactions with EU Regulatory agencies and with our business partners. This role will be focussed on su...
