The Senior Director, Regulatory Strategy, is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs (1) in emerging disease areas, (2) for additional devel

Supports managers and employees, and acts as the direct day to day contact for employees in assigned client businesses Responds to a wide variety of questions and supports multiple service requests simultaneously. Has strong general knowledge of and effective working relationships with all HR functions, especially the Employee and Labor Relations Center of Expertise. Inte

About UMass Amherst UMass Amherst, the Commonwealth's flagship campus, is a nationally ranked public research university offering a full range of undergraduate, graduate and professional degrees. The University sits on nearly 1,450 acres in the scenic Pioneer Valley of Western Massachusetts, and offers a rich cultural environment in a bucolic setting close to major urban

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

Assists the Research Integrity Officer (RIO) and other team members with research integrity investigations. Receives, investigates, documents, and tracks research integrity complaints from workforce members, patients and/or family members. Coordinates with stakeholders, including HR, to develop and implement timely responses to issue reported including corrective action p

This is a remote role; the ideal candidate will live in the New England area. 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

With general direction from the Administrative Manager, the Sr. Grant Administrator will work with the Principal Investigators (PIs) to develop grant submissions, perform budget forecasting, monitor fund statements, resolve accounting issues, function as liaison to grantor agency, subcontracting institutions, and Mass General Brigham Research Management, and support the P

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

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

Under the direction of the Senior Director, Accreditation & Regulatory and working collaboratively, the Accreditation and Regulatory Specialist (Nurse) leads efforts to ensure continual organizational compliance and ongoing readiness with clinical quality and patient safety standards and regulations required by The Joint Commission, Massachusetts Department of Public Heal

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

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