Site Name USA North Carolina Research Triangle Park, Bangalore, India Maharashtra Mumbai, Poznan Grunwaldzka, UK London Brentford, USA Massachusetts Waltham, USA Pennsylvania Upper Providence Posted Date May 9 2024 Are you interested in a highly visible, global role that allows you to lead a team of regulatory experts while being part of the CMC regulatory leadership team

of Key Responsibilities Provides leadership and guidance to various stakeholders to ensure development and implementation of innovative global regulatory strategies across Alnylam's portfolio of combination/device products Provides technical, strategic and tactical regulatory guidance to matrixed product development teams Defines and optimizes global regulatory strategies

Responsible for strategic leadership and direction needed to develop, implement and maintain state of the art microbiology and sterilization assurance methods for Smith + Nephew using a well grounded understanding of technical, scientific and regulatory issues.20 % Develops and oversees Global policies, procedure and training related to cleanrooms, sterilization, and reus

Assists designers with the preparation of master plans and site specific designs. Prepares graphics, maps and diagrams to support planning projects. Conducts planning studies to include feasibility students and assists in coordinating Reuse and redevelopment Master Plans Support public outreach and engagement, with an emphasis on equity. Research and interpret land use, z

Develops, maintains and manages all plan fee schedules and code pricing. Monitors multi state regulations including DHHS, EOHHS, and CMS websites, listservs and other sources to identify existing payment practice and proposed changes. Determine the scope and impact of the change on Plan operations and seek to implement changes as necessary. Business owner in managing soft

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

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

Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas SBSE Small Business/Self Employed, SB/SE Deputy Commissioner Exam, Specialty Examination, Estate & Gift /Excise Tax Exam The following are the duties of this position at the full working level. If this vaca

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

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