Document Management Specialist
Advanced Bio-Logic Solutions Corp.
Date: 3 weeks ago
City: Thousand Oaks, CA
Contract type: Full time
Description
Note:
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.
"This posting is for Contingent Worker, not an FTE"
Note:
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 detail-oriented 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, Smartsheets, SharePoint, and learning management systems (LMS). Adaptability is key, as they must be willing to follow 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.
- 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.
- Project Management/led cross-functional 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
"This posting is for Contingent Worker, not an FTE"
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resumeSimilar jobs
Process Equipment Engineer
Amgen,
Thousand Oaks, CA
58 minutes ago
Join Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine,...
Data Scientist – Attribute Sciences, Process Development
Amgen,
Thousand Oaks, CA
2 weeks ago
HOW MIGHT YOU DEFY IMAGINATION?You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the...
Special Agent
Federal Bureau of Investigation (FBI),
Thousand Oaks, CA
$97,300
-
$125,544
per year
2 weeks ago
JOB DESCRIPTIONWhether the day’s work entails conducting surveillance, identifying leads, interviewing suspects or advising on national security, our work is far more than a typical 9 to 5. Because our Special Agents bring varied backgrounds and knowledge to their role — from educators, athletes and IT specialists to lawyers, linguists and counselors — collectively, they bring their skill sets and...
