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Document Management Specialist

Salary undisclosed

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Development of regulated or process documents with the ability to deliver high quality documentation including technical writing.

Responsibilities:

  • 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, Work Instructions, 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 Quality, Compliance, Learning & Performance group (e.g. Business Process Modelers) 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 (Veeva - CDOCs).
  • Track and provide regular updates to Smartsheet project plan and to key Points of Contact.

Requirements / Qualifications:

  • Experience in developing regulated or process documents with the ability to deliver high quality documentation including technical writing. Strong 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 management systems (e.g., Veeva).
  • Good working knowledge of Microsoft Word 3+ years’ experience preferably in R&D/pharmaceutical industry, with knowledge of quality and compliance.
  • Other duties as assigned for duration of contract.