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Document Management Specialist, Biopharma – Remote (JP9605)

Arvada, Colorado · Biotech/Pharmaceutical
Job Title: Document Management Specialist, Biopharma – Remote (JP9605)
Location: Arvada, Colorado (Remote)
Employment Type: Contract
Business Unit: 
Final Product Technologies Usability Engineering
Duration: 12 months with likely extensions
Rate: $34-38/Hr W2

Job posting date 12/29/2021

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:

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 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 company style guidelines, giving consideration to human factors 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. Management of documents via the established R&D Document Review process using the electronic document repository (EDM Quality and/or VEEVA & CDOCS). 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.
  • 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. 3-5+ years’ experience preferably in R&D/pharmaceutical industry, with knowledge of quality and compliance. SharePoint experience is a plus.

Top Must have Skill Sets:
  • Solutions driven
  • Self-Starter / Resourceful
  • Adaptable
  • 3-5 years of experience in Quality or document control
  • Medical Device or regulated industry experience
  • NOT looking for entry level document control candidates.

Day-To-Day Responsibilities:
Candidate will Draft, or Review, also manage EDMQ workflows for Protocols, Research Studies, Reports, Technical Assessments as needed. Building and supporting maintenance of Usability Engineering File by program/ platform Support regulatory submissions, design review deliverables, and RTQs Build data management system for storage and archival of human factors studies, Data Verify controlled documents

Employee Value Proposition:
This team has a responsibility is to assure that the use of the product/device is safe, fully vetted and de-risked. Their main focus is to help the users want to use the device. Learning and understanding human factors is quickly growing role in this industry so this opportunity will position the candidate for a successful future.

Red Flags:
  • Too many jobs
  • No medical device or regulated industry experience
  • Typos, spelling errors in resume
  • Candidates directly out of college will not be considered

Interview Process:
Phone screen - with 3 HF staff members Onsite interviews 1/2 day

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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