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

Duties WHAT IS THE LARGE BUSINESS AND INTERNATIONAL (LBI) DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Large Business and International Director Northeastern Compliance Practice Area (NECPA) The following are the duties of this position at the full working level. If this vacancy includes more than

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

Duties WHAT IS THE APPEALS DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Independent Office of Appeals Specialized Exam Programs & Referrals/Area 10/Team 2 The following are the duties of this position at the full working level. Conducts Appeals conferences for the settlement of the largest and most

The GRC Specialist is responsible for assessing, managing, and mitigating risks associated with third party vendors and service providers. Implement security best practices, policies, and controls through a repeatable process. This role involves conducting thorough security evaluations of potential and existing vendors, conducting regular security awareness trainings, 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

Lead the management of a portfolio of federal regulations, inclusive of policy development, external advocacy work, and gathering internal feedback in support of the advocacy work. Serve as the regulatory subject matter expert on implementation projects impacted by federal guidance and/or regulations. Advise business stakeholders within Mass General Brigham Health Plan on

Title Security Specialist Start Date TBD Security Specialist Qualifications Applicant must have demonstrated experience working with Classified National Security Information (CNSI) to include Sensitive Compartmented Information (SCI); knowledge and understanding of CNSI and SCI policies; CNSI and SCI instructions; SNSI and SCI regulations; and CNSI and SCI procedures. Dut

The Massachusetts Gaming Commission (MGC) seeks to hire an Assistant Casino Regulatory Manager. With guidance from the Casino Regulatory Manager and the Casino Compliance Coordinator, this position will be responsible for the oversight of the day to day internal operations of the Gaming Agents Unit at the licensed gaming facility. Primarily, this will involve the oversigh

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

Serve public and private sector clients throughout the New England Region, including site due diligence, GIS analysis, concept level site planning, and housing and/or economic development strategy. Support public outreach and engagement, with an emphasis on equity. Contribute to VHB's comprehensive planning practice, with an emphasis on sustainability and public health, f

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

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

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

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