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[Remote] Senior Project Manager, Regulatory Affairs

Remote · Ireland Full-time

Note: The job is a remote job and is open to candidates in USA. Veristat is hiring a Senior Project Manager, Regulatory Affairs to plan, prepare, and execute high-quality projects. The role leads coordination across consulting areas, internal teams, sponsors, and vendors.

Responsibilities

  • The Senior Project Manager, Regulatory Affairs provides management and leadership to plan, prepare, and execute high quality projects
  • S/he interfaces with internal departments and company leadership, and externally with sponsors and vendors
  • The Senior Project Manager, Regulatory Affairs will integrate consulting activities and assignments across all areas of consulting conducted (CMC, quality, regulatory, clinical and business) in coordination with other teams

Skills

  • Bachelor's degree in life/health sciences or related discipline, or equivalent required
  • 6 to 8 years of relevant Regulatory experience in a Clinical Research Organization/Pharmaceutical Company, with a minimum of 3 years of Project Management or functional team lead experience required
  • Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case by case basis
  • Excellent written and oral communication and interpersonal skills, as well as strong planning and organizational ability are required
  • Good working knowledge of drug development process and regulatory requirements, including familiarity with International Conference on Harmonisation (ICH) guidelines and other applicable regulatory rules and guidelines
  • Proficiency in English (written and verbal)
  • Action-oriented and resilient in a fast-paced environment and will have the ability to build effective project teams, motivate others, delegate, and make and implement decisions
  • Ability to build and maintain trust and confidence and communicate effectively with client, external vendors, and internal team members

Benefits

  • Applicable bonus
  • Benefits vary by location and may include remote working
  • Benefits vary by location and may include flexible time off
  • Benefits vary by location and may include paid holidays
  • Benefits vary by location and may include medical insurance
  • Benefits vary by location and may include tuition reimbursement
  • Benefits vary by location and may include retirement plans

Company Overview

  • Veristat is a full service Clinical Research Organization (CRO). It was founded in 1994, and is headquartered in Southborough, Massachusetts, USA, with a workforce of 501-1000 employees. Its website is http://www.veristat.com.
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