Document Management Specialist
Document Management Specialist
Posted on :
02-11-2024
Employer Active
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Monthly Salary
Not Disclosed
Salary Not Disclosed
Posted on :
02-11-2024
Job Description
Title : Document Management Specialist
Location : Thousand Oaks CA (REMOTE)
Duration : 1 year potential for extension to 3 years.
Citizenship Requirement: US Citizens or Perm Residents
Location : Thousand Oaks CA (REMOTE)
Duration : 1 year potential for extension to 3 years.
Citizenship Requirement: US Citizens or Perm Residents
Description:
100% REMOTE Any time zone.
1 year potential for extension to 3 years.
typical schedule follows standard business some flexibility may be needed for meetings etc.
100% REMOTE Any time zone.
1 year potential for extension to 3 years.
typical schedule follows standard business some flexibility may be needed for meetings etc.
The ideal candidate for this role is an organized and detailoriented professional with experience in document control and project coordination preferably within regulated environments like the pharmaceutical or biotech industries. They should have strong communication skills for effective collaboration with subject matter experts be proficient in Office 365 (Word Excel) and ideally have experience with Veeva Vault Smart sheets SharePoint and learning management systems (LMS). Adaptability is key as they must be willing to follow clients specific procedures and standards leaving behind previous methods. This candidate should be comfortable managing multiple projects ensuring timelines are met and maintaining high accuracy in documentation. A commitment to training and ongoing improvement over several months is essential to reach full proficiency in this complex regulated role.
Candidate needs to be able to manage multiple moving parts in a *controlled document environment* Must be able to stick to deadlines/ maintain timelines etc/ (PM related qualities but this is not a PM role).
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 Quality Compliance Learning & Performance 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 Smartsheet project plan 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.
Strong 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 management systems (e.g. Veeva).
Good working knowledge of Microsoft Word 3 years experience preferably in R&D/pharmaceutical industry with knowledge of quality and compliance.
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 Quality Compliance Learning & Performance 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 Smartsheet project plan 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.
Strong 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 management systems (e.g. Veeva).
Good working knowledge of Microsoft Word 3 years experience preferably in R&D/pharmaceutical industry with knowledge of quality and compliance.
Top 3 Must Have Skill Sets:
Project Management/led crossfunctional team
At least 3 years Prior Pharma controlled documentation writing experience
Excellent verbal and written communication skills/writing skills; active listening skills; attention to detail. strong process/business writing skills
Project Management/led crossfunctional team
At least 3 years Prior Pharma controlled documentation writing experience
Excellent verbal and written communication skills/writing skills; active listening skills; attention to detail. strong process/business writing skills
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 based on a process map and/or discussion with Subject Matter Experts (SMEs) and Process Leads.
QC/revise existing documentation according to SOPs Guidance documents (e.g. 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 subprojects representing R&D Quality processes from beginning to end including strategy for process documentation and oversight of documentation.
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 based on a process map and/or discussion with Subject Matter Experts (SMEs) and Process Leads.
QC/revise existing documentation according to SOPs Guidance documents (e.g. 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 subprojects representing R&D Quality processes from beginning to end including strategy for process documentation and oversight of documentation.
1)
2)
And above link for more jobs.
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
