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Document Management Specialist

Thousand Oaks, CA
Day to Day Responsibilities:
  • Draft, or Review, also manage EDMQ workflows for Protocols, Studies, Reports, Technical Assessments as needed.
  • Building and supporting maintenance of Usability Engineering File by program/ platform Support regulatory submissions, design review deliverables, and RTQs Build data management system for storage and archival of HF studies Data Verify controlled documents
  • Development of regulated or process documents with the ability to deliver high quality documentation including technical writing.
  • The primary responsibilities may include, but are not limited to the following:
  • Management of 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.
  • These activities will usually take place virtually and across different time zones.
  • 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. Requirements include:
  • 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
"This posting is for Contingent Worker, not an FTE"
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