Alston & Bird’s Healthcare/FDA Team is seeking a qualified highly motivated non-lawyer candidate who understands the basic workings of the U.S. Food and Drug Administration (FDA). This individual would be responsible for supporting a group of partners and associates focused exclusively on healthcare and FDA issues on behalf of clients that span R&D, manufacturing, distribution and retail spaces related to a wide range of FDA-regulated products including drugs, devices, biologics, food, dietary supplements, cosmetics and tobacco. The core focus of any candidate who fills this position is to support FDA regulatory, policy and compliance and enforcement priorities of the Firm’s FDA clients.
Regularly participating in Healthcare and FDA (including sub-group) team meetings
Monitoring and analysis of FDA regulatory developments
Researching and synthesizing FDA regulatory requirements and expectations
Attend FDA Public Meetings, webinars or other informational events and prepare summaries
Direct contact and interaction with clients
Direct communication with FDA
Facilitating knowledge management for the FDA practice
Assisting in responding to requests for proposals and budgets
Assisting with the drafting of RFPs, business development initiatives, and FDA marketing documents
Reviewing and drafting summaries of FDA Guidance documents, FDA policy statements or other FDA documents reflecting FDA’s current thinking
Reviewing public dockets related to proposed regulations or new of modified Guidance documents
Monitoring industry developments that relate to client issues
Drafting brief, same-day, client-ready summaries of FDA developments
Assisting with the development of regulatory filings and electronic submissions
FDA Compliance and Enforcement
Monitoring, reviewing and summarizing new compliance and enforcement initiatives from FDA
Assisting the team in developing client advisories on new and emerging issues
Reviewing client documents for compliance assessment and investigation purposes
Reviewing and synthesizing information stemming from recent trends in FDA Warning Letters
Assisting with electronic filings made on behalf of clients to FDA (including, at time, nights and weekends)
Assisting with compilation of complex responses to FDA, including reviewing and inputting edits from various authors (client or internal) into a central, controlled document
Reviewing and assembling exhibits, attachments or evidence to support submissions to FDA
Maintaining client filing calendars
Skills Need to be Successful
Ability to establish and maintain effective working relationships within the practice group, with partners and associates, and with clients
Understanding of the basic workings of the U.S. Food and Drug Administration, including the ability to quickly and efficiently navigate FDA’s webpage
Familiarity with, or ability to become familiar with, FDA systems and tools for regulatory and data submissions
Familiarity with the federal regulatory process, comment periods, and federal agency jurisdiction and organizational charts
Strong writing skills with a thorough command of the English language to include excellent spelling, grammar and punctuation
Ability to accurately and quickly edit written materials
Strong organizational skills, with ability to prioritize numerous tasks and complete them properly under time constraints
Strong computer skills, including the ability to master applications that are specific to Alston & Bird
Proven keen attention to detail
Ability to work at the direction of multiple attorneys
Ability to work independently
Two + years of experience in government, preferably at FDA preferred
About Alston & Bird LLP
If you seek a collaborative, diverse and thriving workplace culture, then you’ll enjoy your career with us!
Alston & Bird LLP is an Equal Opportunity Employer that does not discriminate on the basis of race, color, religion, sex, age, sexual orientation, gender identity and/or expression, national origin, veteran status or disability in relation to our recruiting, hiring, and promoting practices.
The statements contained in this position description are not necessarily all-inclusive, additional duties and responsibilities may be assigned and requirements may vary from time to time.
This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor. Requirements are representative of minimum levels of knowledge, skills and/or abilities.
Professional business references and a background check will be required for all final applicants selected for a position.
Alston & Bird is not currently accepting resumes from agencies for this position. If you are a ...recruiter, search firm, or employment agency, you will not be compensated in any way for your referral of a candidate even if Alston & Bird hires the candidate.