Document Control Specialist
A top Biotech companies is looking for an experienced and professional Document Control Specialist to assist their team. In this role the responsibilities of the Document Control Specialist include, but are not limited to:
•Formatting regulatory documents and managing document templates to assure the standards outlined by the authoring style guide are met.
•Providing assistance to authors of multiple functional areas to ensure documents are compliant with authoring style guide.
•Assisting with activities associated with preparedness for future CTD/eCTD filings.
•Providing Electronic Document Publishing support (i.e., scanning, rendering, bookmarking/linking, and document verification) and compiles Module 1-5 in eCTD format and paper
Requirements:Ideal candidates will meet the following qualifications:
•Experience in formatting documents, template development, and PDF document formatting of regulatory submissions
•Experienced in all aspects of preparation and publishing of electronic regulatory submissions in the US (NDA/IND), EU (CTA/MAA). Experience in other major regions (i.e. Canada, Australia, Japan) highly desired.
•Previous experience working with style guide
•Outstanding written and oral communication skills
•Ability to work independently or within a team
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