General Information

Office(s): Atlanta, GA, Baltimore, MD, Boston, MA, Charleston, SC, Charlotte, NC, Columbia, SC, Greensboro, NC, Greenville, SC, Houston, TX, Nashville, TN, Raleigh, NC, RTP, NC, Tysons Corner, VA, Washington, DC, Wilmington, DE, Winston-Salem, NC

Department: Science Advisor

Date Published: 13-Apr-2023

Description & Requirements

• 
  Research and writing using evidence-based scientific principles to address complex regulatory requirements for product submissions.
• Consult with clients on regulatory research efforts to support product submissions for current and future products.
• Contribute to the firm’s existing FDA regulatory expertise by identifying new and emerging scientific theories and methodologies, and applying expertise to proactively serve clients.
• Maintain awareness and proficiency in FDA regulatory guidance documents and agency best-practices for submissions.

• Experience in a professional setting, preferably a consulting firm or law firm
• Demonstrated writing and communication skills and documented interpersonal abilities
• Strong analytical skills and ability to grasp new concepts quickly
• Demonstrated organizational skills: responsive, efficient, independent and proactive in a very fast-paced environment
• Demonstrated proficiency in Microsoft Outlook, PowerPoint, Word and Excel
• Team player, able to interact effectively with all levels of the organization as well as external clients
• Ability to present herself or himself professionally and understand the importance of confidentiality and highly sensitive, client- and firm-related information