Position available

Project Manager

Biologics Consulting Group, Inc. (BCG) seeks to hire a full-time Project Manager with practical experience with INDs and/or BLAs, and related regulatory maintenance activities.   The successful candidate will assist clients with producing quality regulatory documents for submission to the FDA within projected timelines.

Candidate may work predominantly from home; however, must be located in sufficient proximity to work in BCG’s Virginia office, as necessary.

Responsibilities:

Assist clients with:

• Understanding current FDA regulations, policies and guidelines.
• Managing preparation, organization and submission of IND's (legacy and CTD format), BLA's, annual reports and other documents critical to product life cycle.
• Coordinating BCG review teams.
• Planning of documents, participants, and resources for FDA meetings.
• Write/coordinate proposals for projects.
• Perform budget tracking for projects.

Qualifications:

• BS or BA degree required; relevant discipline and/or FDA experience preferred.
• 7+ years experience in IND and/or BLA Project Management and in coordinating documents, participants, etc. for FDA meetings. 
• Familiarity with documents normally included in FDA submissions.
• Comprehensive knowledge of current FDA regulations, policies and guidelines.
• Attention to detail.
• Ability to work on multiple projects simultaneously while maintaining deadlines.
• Able to work both independently and in a team environment.
• Proficiency in formatting of MS Word documents.
• Proficiency in MS Word, MS Excel; MS Project proficiency desirable.

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 40lk plans.

A November 1st start is preferred.

Email Curriculum Vitae to:

Biologics Consulting Group, Inc. is an equal opportunity employer.