Document Management Specialist

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.