Document Management Specialist

Thousand Oaks, California 91320 | Contract

Post Date: 03/23/2018 Job ID: 4030 Industry: Biotech

MUST HAVE SKILL SETS:
  • Experience in developing regulated or process documents with the ability to deliver high quality documentation including technical writing.
  • Sound project management and organizational skills.
  • Ability to work independently and as a team player, demonstrating excellent collaboration and people management skills, preferably to include experience in influencing and negotiation.
  • Experience in leading virtual teams within different regions and cultures.
  • Proficient in discerning, high quality verbal and written communication.
  • Experience of electronic clinical trial/SOP/document systems (e.g., Documentum).
  • Good working knowledge of Microsoft Word.
  • 3+ years’ experience preferably in R&D/pharmaceutical industry, with knowledge of quality and compliance

 

JOB DETAILS: The primary responsibilities may include but are not limited to the following:
  • Management of R&D process documentation per required process (e.g. Standard Operating Procedure [SOP] on SOPs) in accordance with agreed timelines and in adherence with format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
  • Development and facilitation of the creation and/or revision of materials such as SOPs, manuals, and related business process documentation in conjunction with Subject Matter Experts. Note: these activities will usually take place virtually and across different time zones.
  • Liaison with other members of the QCA group (e.g. Business Process Modellers) and also the business (e.g. Business Process Owner, Document Owner, Authors, Subject Matter Experts).
  • Management of documents via the established R&D Document Review process using the electronic document repository (EDM Quality).
  • Track and provide regular updates to process project inventory tool and to key Points of Contact
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