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.