Job description
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
This position can work remotely, or in a WBD office, but may require an in-person training period which will be determined by the supervising attorney.
Essential Duties and Responsibilities:
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
An Equal Opportunity/Affirmative Action/Pro Disabled and Veteran Employer
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