Director, Regulatory Affairs

30 Jul, 2020

Jobs

Director, Regulatory Affairs

Advarra
Columbia, MD

Description

General Summary:

The Director of Regulatory Affairs reports to the Vice President for IRB Review and is a key individual in ensuring robust and regulatorily compliant IRB review.

This position is responsible for ensuring that the Advarra IRBs have adequate and appropriate regulatory guidance and best practices as well as appropriate approaches to non-regulatory issues to ensure compatibility with regulatory interpretations. The Director of Regulatory Affairs works collaboratively and closely with the senior regulatory staff, board members as well as senior leaders in operations to ensure appropriate streamlining and harmonizing of IRB decisions and to identify areas that would benefit from further guidance and training.

Principal Duties and Responsibilities

  • Provide effective leadership to the Board and support the further development of Board resources
  • Provide regulatory guidance and expertise to support the function of the Board and company-wide teams
  • Serve as an affiliated board member
  • Manage and advise on projects including drafting and updating Board SOPs and guidance documents, ensuring that policies and processes are consistent with current regulatory requirements and interpretations
  • Serve as a point of contact for the Board, answering questions and solving day to day Board member, customer, and operational challenges
  • Maintain excellent level of knowledge of business operations, regulatory requirements, and Advarra SOPS
  • Work with Board Leadership to continuously evaluate Board members, processes, and reviews
  • Represent the Board in process improvement activities such as SOP, submission form, and website revisions
  • Work with functional and subject matter experts to develop and follow clear and well-documented processes that meet unpredictable business demands
  • Support a work atmosphere centered on accountability through motivation, team building, training, mentoring, and collaboration to create a highly efficient and successful workplace
  • Identify changes that can improve productivity to better meet Board and customer needs
  • Identify and support training opportunities to support the Board; encourage professional growth and adherence to established business and regulatory standards
  • Work collaboratively with the Management Team to identify and lead implementation of strategic initiatives, goals, and organization structures
  • Other duties as assigned

Job Requirements

Education

  • JD required

Experience

  • 3 years supervisory or related management experience required; or, three years experience at HHS
  • Clinical research services or IRB knowledge base required

Knowledge, Skills, Abilities

  • Strong working knowledge of regulations pertaining to protection of human research participants
  • Demonstrates comprehensive knowledge of business and team processes and how they relate to use and operation of company’s systems
  • Demonstrates leadership and decision-making skills
  • Demonstrates ability to communicate effectively orally and in writing
  • Works harmoniously across all levels and offices of the organization
  • Ability to facilitate group discussion
  • Demonstrated consistency and dependability in performance, including quality and quantity of work
  • Ability to manage and prioritize multiple activities and projects, balancing accomplishment of daily operational activities with strategic projects
  • High level of interpersonal skills to handle sensitive and confidential situations

Physical and Mental Requirements

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; balance; bend; talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, peripheral vision, depth perception, and the ability to adjust focus.

This position requires regular oral/written interaction with clients, team members and the management team.  Infrequent traveling may be required within the United States and Canada.

EEO Statement
Advarra provides equal employment opportunity to all individuals regardless of their race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status, citizenship, genetic information or any other status or characteristic covered by federal, state or local law. Further, the company takes affirmative action to ensure that applicants are employed, and employees are treated during employment without regard to any of these characteristics.  Discrimination of any type will not be tolerated. 
EEO/M/F/Disabled/Vets

Learn more here

Job posted: 2020-07-30