Document Management Specialist

Job Title: Document Management Specialist
Initial 12 Month Contract (extension is performance dependant)
Fully remote with little travel to the client's Uxbridge or Cambridge site
Pay rate/hour: £30 - £36/h (37.5h/week) - INSIDE of IR35

The primary responsibilities may include but are not limited to the following:

• Transform subject matter expert and stakeholder discussion and/or process model flows into written controlled document procedures.
• Under tight timelines, lead and/or facilitate the writing, review, revision, and formatting/QC of controlled documents; while adhering to format, content and style guidelines, considering usability and ensuring accuracy, consistency and quality according to templates and style guide.
• Serve as a process documentation subject matter expert and point of contact.
• Provide regular status updates to manager/team lead/mentor and/or to business customers to achieve goals and meet deadlines.
• Develop, write, edit, and format materials such as Standard Operating Procedures, Work Instructions, and related business process documentation. When creating/revising the documentation, follow internal procedures (e.g., SOPs, Style Guide and checklists).
• Additionally, this position will be required to process documents via the established Research & Development (R&D) electronic document repository (Veeva Vault - CDOCs).
• Preferred: project manage/lead a cross-functional team of subject matter experts to drive R&D Quality processes including management of Smartsheet, identifying Quality strategy, and oversight/generation of process documentation.

Required Skills:

• MS Outlook, (advanced) Word, Excel, and electronic document management repositories. MS Project and Visio experience preferred.
• At least 3 years prior experience specifically as a technical/business writer for writing controlled process documentation (e.g., SOPs, Work Instructions) in the bio/pharma or medical device industry (other regulated environments may be considered).
• Excellent verbal and written communication skills/writing skills; active listening skills; attention to detail. strong process/business writing skills.
• Strong analytic/critical-thinking and decision-making abilities.
• Candidate should have critical thinking skills who is able to work independently with little direction.
• Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.
• Prior experience leading cross-functional team/subject matter experts.
• Role will receive training on R&D structure, initiative/projects, R&D approach to controlled documentation, Quality processes leading/designing a process-based strategy, and controlled documentation templates and style, (process mapping/modeling).

If you would be interested OR if you know someone who is, please get in touch via my details below:

+44 20 3326 4116 (UK)/+353 1 485 4994 (IE)/+31 20 808 1524 (NL)
HCorson@i-pharmconsulting.com