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Document Management Specialist, Biopharma - Remote (JP10182)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Document Management Specialist, Biopharma - Remote (JP10182)
Location: Thousand Oaks, CA (Remote)
Business Unit: Quality Systems

Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date: 5/3/2022

3 Key Consulting is hiring Document Management Specialist 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, Work Instructions, 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 R&D 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 Vault - CDOCs).
  • Track and provide regular updates to project management 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., Veeva Vault).Good working knowledge of Microsoft Word.
  • The Quality Management System (QMS) is the foundation of all that we manufacture, test, and store to support our biggest mission, to serve the patients.
  • This position will support the global Document Management process and a network of
  • Subject Matter professionals to assure the documents generated at company to support our Quality Management System are controlled, effective, and efficient.
Top Must have Skill Sets:
  • Project management (managing multiple projects to completion)
    critical thinking
  • Document creation/revision specific to pharmaceutical and/or biotech industry preferred

Basic Qualifications
3+ years’ experience preferably in pharmaceutical industry, with knowledge of quality and compliance.

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 or Work Instructions or other supporting documents within a controlled document system
  • 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:
You will learn different process area and collaborate with all levels of staff and learn effective communication skills. You will also build project management skills.

Red Flags:

Do not need candidate who has only managed upload of documents to a system
No experience writing regulated/controlled documents
No project management experience
No experience collaborating globally
Multiple short duration projects

Interview Process:
Review resumes, phone screen, virtual interview.
Available to begin review and phone screen next week.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

3KC Talent Acquisition Team
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