This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
As the Deputy Super Office Director for Operations, the incumbent will oversee offices within OND that manage the regulatory, business process, and administrative operations, providing leadership and supervision on developing and implementing relevant processes and procedures, and assuring that key ...
This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. ...
Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Represents the business in interactions with regulatory authori...
The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position involves interpreting ...
This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
The Federal Regulatory Affairs Manager directs US Federal regulatory package/dossier development, product registration, and lifecycle management of all Certis Biologicals products. The Regulatory Affairs team is responsible for obtaining and maintaining regulatory approvals for Certis Biologicals li...
Reporting to the Director of Regulatory Affairs, responsible and accountable for developing and implementing sound strategies for complex regulatory submissions for functional unit. Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and t...
The Regulatory Affairs Specialist is responsible for ensuring that the company aligns with all of the regulations and laws pertaining to our business; working with federal, state, and local regulatory agencies on specific issues affecting our business; and advises the company on the regulatory aspec...
Former experience in leading or guiding more junior technical writers. Writes and updates material for reports, manuals, briefs, proposals, instruction books, catalogs, and related technical and administrative publications concerned with work methods and procedures, and installation, operation, and ...
Responsible for providing services to the Compliance Group to ensure the corporation's compliance with relevant laws, executive orders, directions, and regulations governing mission activities. Use compliance-related tools to audit, monitor, or gather oversight and compliance data. Coordinate compli...
The Level 3 Quality Assurance Specialist shall possess the following capabilities:. We're searching for talented individuals who provide Quality Assurance support. Review and provide feedback to the Government on the documents and deliverables ensuring that quality assurance requirements adhere to t...
Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists with a focus on study activation. Lead a team of Research Regulatory Specialists and/pr Coordinators. Prepare and/or provide guidance to Regulatory Special...
Remote Pharmacists support multiple Encompass Health hospitals, each with a daily census of 30 to 60 patients. The Remote Pharmacist participates with other members of the healthcare team helping patients achieve positive clinical outcomes by monitoring, evaluating, verifying, ordering, and making r...
Civics Education Project is a dynamic and passionate consulting firm dedicated to creating positive change in our community. ...
HIAS seeks a Program Specialist, Quality Assurance & Training to coordinate data collection, cleaning and analysis in the Preferred Communities (PC) program and to provide the HIAS affiliate network with technical support as needed, in close collaboration with the Program Manager, Preferred Comm...
Prior experience of working as an Account Manager/Project Manager within a digital agency. Digital Project Manager - Web. We are looking for a Digital Project Manager to lead website implementations and digital strategy efforts. T...
CF; A minimum of 5-7 years of experience as a writer on technical proposals. CF; Write proposal content, including technical sections, management and staffing sections, resumes, and. Bachelor’s degree in a relevant topical area and/or English, Communications, or a technical discipline. C...
Williams Consulting, LLC is seeking an experienced Technical Communication Writer/Editor to provide technical writing/editing support of a mission critical Federal program. Williams Consulting, LLC (WCLLC) is searching for a Technical Communication Writer/Editor with federal government contracting e...
The Associate General Counsel, Regulatory & Quality, will support a wide variety of FDA regulatory and quality matters related to the design, manufacture, distribution, and sale of Getinge medical devices worldwide, including product submissions, premarket activities, quality system regulations, man...
If so, we 're looking for someone like you to join our team! We are seeking a Compartment Security Compliance Project Analyst (CSCPA) to help provide APL and its sponsors with the highest level of security support. Compartment Security Compliance Project Analyst (CSCPA). Provide security guidance re...
Overview: The Senior Risk and Compliance Analyst is internal to Inovalon and part of the Security, Risk and Compliance department that partners with Technology, business groups, and project teams to perform risk and compliance activities and audits for applications, infrastructure, and vendor/third ...