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.
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 email@example.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.