familiarity with documents normally included in FDA submissions
familiarity with all FDA electronic submissions guidance documents
ability to communicate clearly with clients regarding ongoing projects
attention to detail
ability to work on multiple projects simultaneously while maintaining deadlines
ability to work on projects involving large numbers of documents
requires minimal instructions on routine work and new assignments
comfortable working in a team environment
Telecommuting is allowed.
Internal Number: epub-2021
About Biologics Consulting Group
Biologics Consulting is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. In the twenty-five years since its founding, Biologics Consulting has built an unprecedented record of achievement, assisting clients internationally to address nonclinical, clinical, product development and manufacturing, and regulatory compliance challenges.
The cornerstone of this success is found in our team of consultants and professional services staff, comprising subject-matter experts with decades of industry and/or FDA experience. Biologics Consulting offers a great work environment, as well as a highly competitive salary and benefit package, including healthcare, 401k, and ESOP plans.
Biologics Consulting Group, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with a disability.