Job Description
Description: REPOST OF AMAGJP00013345
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.
- 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.
Other duties as assigned for duration of contract.
Top 3 Must Have Skill Sets: - 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
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 "sub-projects" representing R&D Quality processes from beginning to end including strategy for process documentation and oversight of documentation.
Pay Rate- between $38 - $43/Hr. on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"Advanced Bio-Logic Solutions Corp
Job Tags
Contract work,