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Document Management Specialist-Remote -(JP9809)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Document Management Specialist-Remote (JP9809)
Location: Thousand Oaks, CA 
Employment Type: Contract
Duration:12 months with likely extensions
Job posting date2/15/2022
Note: Remote

3 Key Consulting is hiring a Document Management Specialist-Remote for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
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 Quality 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 process project plan (Smartsheet) 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 critical thinking and adherence to process and procedure.
  • Experience in leading virtual teams within different regions and cultures.
  • Proficient in discerning, high quality verbal and written communication.
  • Experience of electronic document management systems (e.g., Veeva Vault).
  • Good working knowledge of Microsoft Word. 3+ years’ experience preferably in R&D/pharmaceutical industry, with knowledge of quality and compliance.
Top Must have Skill Sets:
  • Critical Thinking
  • Project management
  • Managed projects (create documentation experience) 1- years
  • Previous document writing skills
  • Worked and written procedural documents (Pharma industry)
Day-To-Day Responsibilities:
  • work independently to support controlled document edits, format and/or create SOPs or Work Instructions based on a process map or
  • QC/revise existing controlled 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.
Employee Value Proposition:
  • Interacting with different levels of people.
  • Gain experience in Pharma Industry.
  • Better serve patients and the public.
Red Flags:
  • Do not need someone who managed documents in a Trial Master File (uploading documents)
  • No previous project management
  • No previous controlled document writing
  • no collaboration with key stakeholders
Interview Process:
phone screen
video interview 

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. 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. You are welcome to also share this posting with anyone you think might be interested in applying for this role.

3KC Talent Acquisition Team
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