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"