Electronic Publishing Specialist

Electronic Publishing Specialist

Biologics Consulting Group, Inc. seeks to hire an entry-level, full-time electronic publishing associate with experience publishing electronic IND, Master File, BLA, and NDA submissions.

This is a remote position. The Electronic Publishing Associate will be able to connect remotely to the Biologics Consulting Alexandria, Virginia office for work.

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 eCTD-formatted submissions
  • Validate eCTD applications according to FDA specifications
  • Detailed tracking of project progress
  • Audit of submissions for completeness, bookmark/hyperlink accuracy, correct document placement, etc.
  • Submission of applications and sequences through the FDA Electronic Submissions Gateway
  • Write proposals for publishing projects

Qualifications:

  • College degree in relevant discipline preferred
  • experience with multiple tools/plug-ins used for publishing FDA guidance compliant PDF documents (e.g. ISIToolbox, a-Pulse)
  • experience with eCTD publishing software/Validation tools (ARIM, eCTD Manager, docuBridge, etc.)
  • 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 is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. In the twenty-six 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, gender, national origin, age, protected veteran status or status as an individual with a disability.