Electronic Publisher: Mrinetwork Klein Hersh International

Electronic Publisher

We have a new opportunity with one of our international clients in the Philadelphia area.

POSITION SUMMARY

The Electronic Publisher plays a part in the development and application of electronic publishing tools to compile and publish electronic regulatory submissions.

PRIMARY RESPONSIBILITIES

· Candidate will provide support to Cherry Hill , New Jersey , San Francisco , California , and Allschwil , Switzerland sites to include:

o Use and develop electronic publishing tools to compile and publish electronic regulatory submissions.

o Provide electronic publishing support including hyperlinking and bookmarking study reports, CRFs and other documents and using software such as ISIToolbox to ePublish PDFs.

o Upload document to iTRACK and provide iTRACK user support and training

o QC formats, reformatting to standards as required, and electronic approval as required to ensure compliance of electronic documents with eCTD standards, requirements and publishability

o Work with Drug Regulatory Affairs Operations and Publishing Coordinator to contribute to overall planning activities, including US-generated submissions.

Candidate Requirements

QUALIFICATIONS

· Bachelor’s degree

· Excellent MS Word and Acrobat skills

· Experience with electronic document management systems

· Experience in ePublishing of documents and publishing eCTD submissions

· Knowledge of pharmaceutical industry and regulatory documents

· Excellent written and verbal communication skills

· Attention to detail

· Ability to work independently

· Able to prioritize tasks, good organization, problem-solving and follow-up skills

PREFERRED QUALIFICATIONS:

· Knowledge of XML

· Knowledge of ISIT Toolbox

· Experience working effectively in a matrix environment