: Document Management Specialist (JP7705)
Thousand Oaks, CA
: 12 months with likely extensions
Job posting date
Remote until COVID-19 restrictions are lifted.
3 Key Consulting is hiring a Document Management Specialist for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
- Candidate will be sitting remote then required to be on site once open.
- 3+ years of experience working with controlled documents. (Ideally) -R&D/pharmaceutical industry, with knowledge of quality and compliance.
- Ideally Bachelors Degree.
- Must have experience managing projects - multiple projects at one time.
- Candidate will not be writing the documents, will be getting the documents through process
- Document management: 1 - 20 documents in motion at any given time.
- 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 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.
Top 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 (Skype/WebWex etc).
- 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.
- Advanced Microsoft Office (Word & Excel).
- Previous management of Projects.
- At least 3 years prior experience as technical/business writer for controlled documents.
Day to day responsibilities will vary by project and day and will include a combination of the following:
Employee Value Proposition:
- Work independently to edit, format and/or write SOPs and other controlled process documents based on a process map or QC/revise existing documentation according to template/style guide.
- Act as “scribe” writing documents according to template/style guide during meetings with subject matter experts.
- Lead team of subject matter experts to facilitate discussion and review of process and documentation with time, experience, and demonstrated ability.
- Role may serve as a project manager to lead “sub-projects” representing R&D Quality processes from beginning to end including strategy for process documentation and oversight of documentation.
Opportunity to interact & learn about different phases in clinical trials, safety & regulatory
- No previous experience working in a controlled document environment.
- No previous experience with project management.
Phone screens and then virtual meetings for selected candidates.
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
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