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Document Management Specialist (JP7705)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Document Management Specialist (JP7705)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date: 2020
Note: 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.
Job Summary:
  • 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.

    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 (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.

Top Must have Skill Sets:
  • 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:
Day to day responsibilities will vary by project and day and will include a combination of the following:
  • 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.
Employee Value Proposition:
Opportunity to interact & learn about different phases in clinical trials, safety & regulatory
Red Flags:
  • No previous experience working in a controlled document environment.
  • No previous experience with project management.
Interview Process:
Phone screens and then virtual meetings for selected candidates. 
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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