SAS

Principal Regulatory Affairs Advisor

Job Locations US-VA-Arlington | US-NC-Cary HQ
Requisition ID
20036476
Category
Consulting
Travel Requirements
25%

SAS seeks a FDA Strategic Consultant with proven experience working in medical product development and possessing expertise surrounding the federal policy dynamics shaping clinical and device development and drug and device commercialization. Candidate must possess direct experience working with the Food and Drug Administration (FDA) – either within the Agency or in the commercial life sciences industry. This candidate will use their regulatory policy and life sciences knowledge to advance SAS analytic solutions, deepen industry relationships and win new business opportunities.

 

Primary Responsibilities:

 

Reporting to the Manager of Health Policy in U.S. Government, the candidate will provide executive leadership for SAS within the FDA and life sciences ecosystem. Responsibilities and functions include:

 

Knowing SAS

  • Learning current SAS products, practices, service offerings and resources that help position SAS within the FDA ecosystem and grow new customer sales and solution implementation opportunities.
  • Understanding of enterprise level business process flows in areas related to supported solutions.

Planning and Supporting Sales Activities

  • Develop industry specific business development strategies that enables the SAS sales force to establish SAS as the preferred partner for key advanced analytic platforms at the FDA. These strategies will need to address what solutions are best suited for current and future client needs.
  • Identify industry trends and sources of major disruption in the industry that well-position SAS and its offerings
  • Establish strategic vision and value propositions based on SAS offerings and the demand of the industry
  • Articulate compelling SAS solution capabilities at the C-level within the FDA and across organizational layers, as well as with key life science clients
  • Provide support and strategic guidance to SAS sales organization leadership to develop new account penetration strategies
  • Assist with identifying additional business needs and sales opportunities to address what solutions are best suited for current and future client base
  • Work with Federal lobbying infrastructure needs and identify any gaps in SAS’ existing offerings that need to facilitate SAS positioning
  • Identify competitive advances in the marketplace.
  • Build customer references and support strategic opportunity growth through project expansion and identification of new sales opportunities.
  • Develop and maintain relationships with FDA and other key stakeholders to identify and develop effective strategic alignment of SAS solutions to their current and future needs. position.

 

Required Qualifications:

 

  • Bachelor's Degree, Master’s preferred, in Business, Business Marketing, Biology, Public Health, Biostatistics or related discipline
  • Require 8+ years of experience in the U.S. FDA and/or support organizations with hands on experience working on drug development, review and lifecycle management policy.
  • Proven ability to work collaboratively to facilitate business development strategies
  • Work location: Cary, NC, Arlington, V.A., Washington, D.C. or proximate surrounding area(s)
  • Knowledge of the FDA, life science regulatory industry, pharmaceutical companies, and/or Clinical Research Organizations
  • Excellent communication skills and ability to work collaboratively in a dynamic team environment.

 

Additional skills:

 

  • Deep knowledge of current issues and trends with healthcare data integration and advanced analytics applications within industry, state and local government agencies.
  • Demonstrated experience in industry domain policies, procedures, relationships and credibility.
  • Demonstrated ability to present to all levels of an organization.
  • Excellent analytical and creative problem-solving skills.
  • Ability to work independently and as part of a team.
  • Excellent project management and facilitation skills.
  • Experience supporting sales across all stages of the customer lifecycle.
  • Ability to understand and translate complex technical and business information to non-technical internal/external audiences.

 

Additional information:

 

SAS is an equal opportunity employer. All qualified applicants are considered for employment without regard to race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status or any other characteristic protected by law. Read more: Equal Employment Opportunity is the Law. Also view the supplement EEO is the Law, and the Pay Transparency notice. 

 

Equivalent combination of education, training and experience may be considered in place of the above qualifications. The level of this position will be determined based on the applicant's education, skills and experience. Resumes may be considered in the order they are received. SAS employees performing certain job functions may require access to technology or software subject to export or import regulations. To comply with these regulations, SAS may obtain nationality or citizenship information from applicants for employment. SAS collects this information solely for trade law compliance purposes and does not use it to discriminate unfairly in the hiring process.

 

All valid SAS job openings are located on the Careers page at www.sas.com. SAS only sends emails from verified “sas.com” email addresses and never asks for sensitive, personal information or money. Should you have any doubts about the authenticity of any type of communication from, for, or on behalf of SAS, please contact us at Recruitingsupport@sas.com before taking any further action.

 

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