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

The Ragon Institute is a highly unique, innovative, and collaborative research center at the forefront of biomedical science. Founded by Massachusetts General Hospital, MIT, and Harvard, the Ragon vision is a bold one to harness the power of the immune system to prevent and cure human disease on a global scale. This vision is pursued and advanced every day by a group of h

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

Are you a current UMass Memorial Health caregiver? CLICK HERE to apply through your Workday account. Schedule Details Monday through Friday Scheduled Hours 8 5 Shift 1 Day Shift, 8 Hours (United States of America) Hours 40 This position may have a signing bonus available a member of the Recruitment Team will confirm eligibility during the interview process. Everyone Is a

At Boston Children's Hospital, the quality of our care and our inclusive hospital working environment lies in the diversity of our people. With patients from local communities and 160 countries around the world, we're committed to reflecting the spectrum of their cultures, while opening doors of opportunity for our team. Here, different talents pursue common goals. Voices

If you are passionate about innovative therapies, love leading complex regulatory filings, and live for quality, on time, and within budget project deliverables, Parexel is E X P A N D I N G and we currently have openings for Senior Regulatory Affairs Consultants / Regulatory Affairs Leads. These are incredible opportunities to join a tight knit team of amazingly nice and

of Role Responsible for integrating and applying advanced knowledge of global regulations governing pharmaceutical drug development and commercialization to all aspects of assigned preclinical and/or clinical drug development programs, policies, and procedures, to ensure the rapid and successful development and registration of products while maintaining compliance with all

Develop, implement, and lead the regulatory regional strategy, in alignment with company goals, for new and sustaining ZOLL Resuscitation products and features. Essential Functions Develop and successfully implement regional regulatory strategies for new and sustaining products/features that result in device approval. Ensure project team colleagues, line management, and k