Regulatory Health Consultant, Senior in Rockville, MD

  • Secure Aspects Group
  • 09/16/2018

Job Description

Job Number: R0022140

Regulatory Health Consultant, Senior

Key Role:

Apply problemâsolving expertise in health or life science to develop solutions to operational and strategic challenges for federal public health agencies. Work with project delivery teams to provide leadership and analytical support in the execution of project approaches and development of deliverables and strategic recommendations to drive organizational improvements in business processes, program operations, strategic planning, policy effectiveness, and decisionâmaking. Perform independent quantitative and qualitative data collection and analysis methods to derive insights on client issues, evaluate trends, and assess potential solutions. Develop and support or lead communications of practical solutions to clients in the form of dataâdriven presentations, briefings, and reports. Support business development objectives by contributing to proposals and marketing efforts.

Basic Qualifications:

-6+ years of experience in a professional work environment

-1+ years of experience with the health or medical product industries, including R&D, clinical, regulatory, marketing, strategy, operations, manufacturing, or consulting

-1+ years of experience with strategy or management consulting

-Knowledge of medical product development and regulatory pathways

-Ability to work in a teamâbased or project environment

-Ability to lead projects or tasks

-Ability to obtain a security clearance

-BA or BS degree

Additional Qualifications:

-1+ years of experience in working with the FDA

-Possession of excellent analytical skills

-Possession of excellent oral and written communication skills

-MA or MS degree in a life scienceâ, engineeringâ, or healthârelated field or MBA degree preferred; PhD degree in life scienceâ, engineeringâ, or healthârelated field a plus

-Lean Six Sigma Certification

-Regulatory Affairs Certification (RAC)

-Project Management Professional (PMP) Certification

Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

Weâre an EOE that empowers our peopleâno matter their race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or veteran statusâto fearlessly drive change.

Start Date

Sun, 09 Sep 2018 04:04:15 EST