Position available

Title: Associate – Electronic Publishing

Biologics Consulting Group, Inc. (BCG) seeks to hire a full-time electronic publishing associate with practical experience publishing electronic IND, Master File, BLA, and NDA submissions.  

Candidate will work from BCG’s Alexandria, Virginia office.

Responsibilities:

Major Duties and Responsibilities:

• Convert source documents in various formats to FDA guidance compliant PDF documents
• Bookmark and hyperlink PDF documents per FDA specifications
• Compile PDF documents into both legacy and eCTD submissions
• Detailed tracking of project progress
• Audit of submissions for completeness, bookmark/hyperlink accuracy, correct document placement, etc.
• Write proposals for publishing projects

Qualifications:

• BS or BA  degree; relevant discipline preferred
• 1-2 years hands-on experience with electronic submissions publishing
• experience with multiple tools/plug-ins used for publishing FDA guidance compliant PDF documents
• experience with eCTD publishing software
• proficiency in formatting of MS Word documents
• 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

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.

An immediate start is preferred.

Email Curriculum Vitae to: