Documentation Specialist
- Remote
- Contract
- Drug Safety / Pharmacovigilance
Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Documentation Specialist. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness.
Responsibilities include:
- 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)
- 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.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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