Basic Qualifications:

• BS/MS in Natural Sciences, Project Management, or Nursing
• Experience in the Biotech, Pharmaceutical Industry, or FDA Project Management environment (Required).
• 2+ years managing cross-functional projects/teams using project management methodologies and tools for complex product/process development environments
• Working familiarity with FDA and/or ICH regulations
• Prior experience in interacting with FDA (CBER, CDER) in project review capacity

Preferred Qualifications:

• Advanced degree (e.g. MS, Ph.D) in Natural Sciences
• Project Management Professional (PMP) Certification

Skills:

Proficient in Microsoft Office Suite, keyboard skills, oral and written communications skills, strong documentation skills, math aptitude, diplomacy, professionalism, organization, time management, ability to multi-task, able to work unsupervised, able to maintain confidentiality

Education and/or Experience:

College Degree required – preferred in field of Biology, Natural Sciences or Regulatory Affairs. Prior experience in regulatory affairs is advantageous.

Biologics Consulting Group, Inc. (BCG) is an international consulting firm whose consultants provide national and international regulatory and product development advice on the development and commercial production of biological, drug, and device products. Our staff consists of experts in regulatory affairs, product manufacturing and testing, pharmacology/toxicology, facility inspections, statistics, program management, and clinical trial design and evaluation. Many of our consultants are former CBER, CDER and CDRH reviewers, certified FDA inspectors, and senior scientists from the biotechnology industry. We offer a great work environment, as well as a highly competitive salary and benefit package, including healthcare and 401k plans.

An immediate start is preferred.