Works as Global Regulatory Leads (GRLs). Positively contributes to the regulatory probability of success for clinical and commercial therapeutic programs. Represents Regulatory at the Global Development Team with relevant line function leaders. Develops and delivers on fit for purpose high quality documentation (e.g., INDs, CTAs, NDAs, reports, and correspondences) to supp

Government Relations Manager United States Virtual Req #463 Thursday, December 28, 2023 Want to help people learn the newest ways of working and getting things done? How you'll make a difference You will be responsible for planning, developing and executing a strong positive government relations and advocacy program for PMI. You will be fostering a community relationship

The Senior Manager, Regulatory Affairs CMC supports RA CMC gene therapy development product(s) and provides support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. They will work closely with subject matter experts within CMC technical operations and QA working within a CMC sub team structure and serving as a member of the GRT. The Senior Manager will a

Newport, an Ascensus company, helps employers offer their associates a more secure financial future throughretirement plans,insuranceandconsulting services. Newport offers comprehensive plan solutions and consulting expertise to plan sponsors and the advisors who serve them. As a provider and partner, Newport is independent, experienced, and responsive. Job Summary Assist

Under the direction of The Fenway Institute's Associate Medical Director and the Clinical Research Operations Manager, the Study Coordinator will work with staff in the BioMedical Research Program at The Fenway Institute to support and implement clinical trials funded by a government agencies and/or industry sponsors. Please note that TFI works on multiple projects and wi

This position defines and executes the risk management framework for the enterprise or business areas across the organization. Leads activity to balance risk and reward within the enterprise or business risk appetite. Provides risk advice, information and results to functions across the organization to provide reasonable assurance regarding the achievement of strategic obj

The Principal Regulatory Specialist is responsible for carrying out Pre Market and Post Market regulatory activities in compliance with Digital Factory's Quality Management System for domestic and various international markets for SaMD products. This role shall provide product level leadership and initiative by independently developing and executing regulatory strategies

Research Administration Assists with grant proposal preparation as assigned. Prepares detailed budgets and justifications and gathers documents from all personnel included in the proposal. Creates Insight record and performs data entry of grant application materials into sponsor forms according to funding agency guidelines. Prepares/updates biographical sketch, and other

1. Support the grant proposal and reporting process throughout all stages of the research grant life cycle. 2. Prepare and assist with grant application submissions 3. Reading and understanding sponsor guidelines. Sponsors include and are not limited to NIH, NIA DoD, foundation, international agencies, industry. 4. Completing sponsor forms 5. Preparing budgets with input

Regulatory Coordination Prepares and submits protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval. Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies and offices. Prepares, maintai

The Grant Administrator will work closely with others on the administrative team and within a highly collaborative environment to further the Center's mission and goals. Principal duties include Partnering with Principal Investigators and other study staff to oversee all aspects of the grant application process for selected proposals, including development of study budget

Reporting to and working closely with the Institute Administrative Director, the Sr. Grant Administrator will support the research administration and grant management activities for multiple investigators in the Clinical and Translational Epidemiology Unit (), a research center within the Mongan Institute. Serving as the primary liaison between the investigators, MGB Rese

I. RESEARCH ADMINISTRATION Manages all financial and administrative aspects of an $8 10M research portfolio, including management of complex grant mechanisms and multicenter clinical trials Manages all phases of research grant and contract administration (for NIH, industrial, foundation grants, sundry funds, clinical trials, etc.). Coordinates and manages grant submission

As part of the Grants Management Team of the Division of Rheumatology, Allergy and Immunology (DRAI) and the Center for Immunology and Inflammatory Diseases (CIID) and under the direction of the Research Administrative Manager, the Grant Administrator is responsible for the Pre and Post award grant and contract administration (NIH, Industrial and Foundation grants, Contra

In order of importance, list essential areas of responsibility, major job duties, special projects and key objectives for this position. These items should be evaluated throughout the year and included in the written annual evaluation. This section should be completed as a bulleted list and explain how the role is performed. Work with faculty and fellows in the preparatio