Document Management Specialist
One Amgen Center Drive Thousand Oaks, California 91320 | Contract
MUST HAVE SKILL SETS:
- 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
JOB DETAILS: The primary responsibilities may include but are not limited to the following:
- 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, manuals, 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 QCA group (e.g. Business Process Modellers) 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 (EDM Quality).
- Track and provide regular updates to process project inventory tool and to key Points of Contact