Regulatory affairs officer

... report forms. Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed. Assemble study kits for study visits, monitor scheduling of procedures and charges, ... study conduct. Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. Participate in monitor visits and regulatory audits. *- Other duties may also be assigned DESIREDQUALIFICATIONS: Priorclinical trial coordination Oncologyexperience ...

... and written communication during regular status updates and technical reports. Proactively identify and escalate risks and issues to relevant stakeholders; lead development and delivery of tactical and achievable mitigation and contingency planning. You will drive pre-IND activities and direct drafting/filing of related regulatory filings. As a Senior Project Manager, you will act as a mentor to new project management staff by providing initial training and leading on-going "lessons learned" exercises. You will be a strong voice continuous process improvement activities for project management process and tools that are utilized by the ...

... and much more. Posted Job Title Financial Aid Loan Specialist - Division of Finance Job Profile Title Loan Officer Job Description Summary Join a team of financial aid experts in an operation that focuses on student ... regulations, policies, and procedures that affect their aid packages. In compliance with Federal regulatory guidelines for loan administration, the Student Loan Specialist will evaluate and determine student ... loan programs, their eligibility criteria, application processes, and transmission methods; Federal regulatory guidelines for the administration of Title IV and Title VII loans. Ability to research, evaluate, ...

... Group will be part of the Global Regulatory Operations group and will develop and ... Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory ... years experience in pharmaceutical regulatory Technical system skills (e.g. Microsoft ... RIM) Hands-on experience in preparing regulatory submissions during development and for ... Knowledge of pharmaceutical industry regulatory development activities. Experience with ... products Ability to interpret Regulatory Authority policies and guidance and ... apply them as appropriate in product regulatory activities. Ability to influence and ... the business drivers outside of Regulatory Affairs. Excellent communication skills; ...

... ensures that quality systems are developed and maintained to regulatory standards and Incyte standards. This position is responsible ... auditing, and training. Ensure readiness for inspection by regulatory agencies. Monitor and communicate compliance and quality ... managing and/or participating in regulatory agency inspections including responding to regulatory agency observations requiring ... with federal regulations. Keep current on governmental regulatory requirements related to Good Laboratory Practice for ... it, and contact information for Incyte, Incytes data protection officer, and your supervisory authority (if applicable). Please contact ...

... lab packing to support personnel, ordering only clinically necessary and cost effective labs and facilitation of positive patient outcomes with patients, nursing agencies, and other healthcare providers. Performs other duties as assigned. Serves as Process Owner as assigned. Serves as compliance officer. Responsible for completing all mandatory and regulatory training programs Qualifications: Educational Requirements: Bachelors Degree (BS) in Pharmacy or a Pharm.D. from an accredited college or university; Experience: Prefer one year of experience in an IV alternate site environment or equivalent work experience. Credential/Licensure Required: ...

... Duties will include but are not limited to: Provide product technical support to cross-functional teams such as, but not limited to, Sales, R&D and Regulatory Affairs. Conduct experimental studies (e.g. Simulations, DOEs) to support product investigations and customer development activities. Provide risk analysis to support ... trending of inspection and test data to ensure optimal product performance. Support the creation of product line training materials. Interface with Regulatory Affairs ensuring products meet regulations for US/Canada markets. Manage assigned Corrective and Preventive Actions (CAPA). Collaborate with global partners and ...

Overview: Officer I - Protective Services Under the general supervision of ... Services Lieutenant, the Officer is responsible for providing ... during the assigned shift. The Officer shall respond safely, ... undergo a 4 to 6 week training cycle. The Officer will be placed with a ... and experience. The Officer will learn multiple task in a ... and verbal techniques. Once the Officer has completed training the ... criminal statutes, and regulatory publications. 4. Ability to ... Officer will be required to complete the IAHSS Basic Security Officer ... being hired at the officer?s expense. Once the officer has successfully ... Department will reimburse the officer the cost of the test. MINIMUM ...

... security solutions for our clients. To us, that means the right officer in the right place and at the right time. In many cases our ... prefer a more obvious security presence. As an Unarmed Security Officer, you will be part of a highly trained security team that supports ... and personal protective services. As an Unarmed Security Officer, you are an integral part of the broad spectrum of specialized ... by the States and/or Countries of assignment to perform security officer duties. Inter-Con Overview Founded in 1973, Inter-Con Security ... careers in law enforcement, government agencies, foreign affairs and many more. Your career success drives our success. Benefits: ...

... while interfacing with R&D, Marketing, Sourcing, Quality, Global Regulatory Affairs, and other Herbalife corporate and regional personnel in a collaborative ... cost, enhance the brand, improve manufacturing efficiency and meet quality/regulatory requirements. Determine stability of formulations and ensure commercial ... priorities and focus to drive correct decision making Understand basic global regulatory requirements, including EU, CAN, APAC/CH, MX, SAM/CAM Good working knowledge of ... working with other departments that interface with R&D such as QA, QC, Regulatory, Manufacturing, and Supply Chain Education: Required BS degree with a major in ...

... for providing risk management support and execution to the Markets business. The position will primarily focus on direct support of the Risk and Control Self Assessments (RCSA) across the CIB Markets business. The individual should demonstrate brilliance in the basics in the execution of the RCSA function to meet regulatory commitments on time and with sustainable quality, while measurably improving the Wells Fargo control environment through addressing control gaps, creating control documentation and maintaining the accuracy of the RCSA. This role will be expected to take on accountabilities in support of the risk transformation initiatives and ...

... ICI project, working collaboratively with other departments including Operations, Legal Operations, Asset Optimization, Compliance, and Government & Regulatory Affairs to assess the potential impact of each ICI activity and to develop and execute strategic action plans to achieve the desired outcomes. Coordinate the ... liaising with the leaders and staff from other departments including Operations, Legal Operations, Asset Optimization, Compliance, and Government & Regulatory Affairs. Utilize data gathering and analysis techniques to monitor and analyze macro and specific market trends, competitive landscape, industry dynamics to identify ...

... to optimize production processes and improve overall operational performance. Regulatory Compliance: Ensure engineering activities adhere to industry regulations, safety standards, and compliance requirements. Collaborate closely with regulatory affairs to stay updated on changes in the food manufacturing industry. Quality ... experience in the food manufacturing industry. Demonstrated success in project management, process optimization, and quality assurance. Strong knowledge of regulatory requirements and compliance standards in the food manufacturing sector. Exceptional leadership and team management skills. Excellent communication and ...

... coordinates action plans with the Service Line Physician leadership and the Director/Physician Practices or COO or Senior Manager. Ensures compliance with all regulatory and accreditation mandates to which the organization is subject, company policies, procedures, and programs, ensuring consistent application within their service ... Line operations. Participates with Marketing and Sales Department in Service Line promotion to enhance organizational growth and becomes involved in community affairs that enhance the image of the Service Line and OHPG/Orlando Health. Ensures coverage of roles during staff shortages, vacations, sick or other leaves in order to ...

... with Minimum Internal controls as defined by Morongo Gaming Agency Essential Duties And Responsibilities: Participates in the development and implementation of MCRS strategic plan for all Information Technology initiatives and resources to support ongoing property operations. Ensures compliance with all operational and regulatory policies and guidelines. Ensures all technologies are used effectively and securely. Develops and implements a comprehensive technology strategy that aligns with MCRS long term goals. Evaluates hardware and software requests and requirements and makes recommendations aligned with property wide business strategies. ...

... drawings, and visual communication(s) to customers and internal stakeholders for review and approval. Ensures network designs are in compliance with all regulatory policies, procedures and records. Collaborates with R&D, Digital Factory and Service to design a predefined network diagrams portfolio to successfully ... by Digital Solutions Service Director. Networking/Key Relationships Digital Solutions Service team Development and QA teams PPSO (Product Privacy Security Officer) Local service teams Local marketing teams WW Marketing Product Managers WW Service Qualifications: Minimum Knowledge & Experience required for the position: ...

... Affairs Strategy, oversees the implementation of ... and identifies regulatory requirements for ... Serves as primary regulatory contact for ... purposed against regulatory requirements. ... of global regulatory legislation and ... an effective regulatory affairs ... basis (CMC, Regulatory Operations, US ... and International regulatory). REQUIRED ... experience in Regulatory Affairs. Experience ... regulatory compliance. Regulatory ... execute regulatory strategies. ... compliance and regulatory strategies. Seeker ... complicated regulatory and systems ... to influence regulatory agency management ... levels to support regulatory needs. Highly ... international regulatory affairs, including ...

... if related to diagnosis, charge and/or other clinical type data that RCBS would not have knowledge of. Ensures all Compliance errors are reported to the Director and maintain records and files of documentation supporting bill changes that are directed by Director and/or Integrity Officer. Responsible to ensure successful implementation of Governmental Regulatory Billing changes, including but not limited to Medicare OPPS effective August 1, 2000. Responsibilities: Ensures daily productivity standards are met and daily EOB'S, reports and appeal files are cleared with in 48 hours of receipt (allowing for weekends and holidays) Log IPOs as ...