We are seeking an experienced Regulatory Generalist to join our FSP team as a Senior Regulatory Affairs Associate / Regulatory Affairs Consultant to work closely with one large, dedicated client and provide operational support in the IND/NDA maintenance stage. The Sr. Associate / Consultant will also provide appropriate regulatory guidance to Project Teams for the develop

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

Parexel's Strategic CGMP Compliance team is known for our unparalleled breadth and depth of expertise globally. Parexel CGMP Compliance offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre eminent regulatory and GxP (Good Clinical

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

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

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

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