CK Group are recruiting for a Document Management Specialist to join a Biotechnology company based in Cambridge. This company manufactures a wide range of pharmaceutical products for the human health market and this is a fantastic opportunity to join them on a 12 month contact initially.
The main purpose of the role will be:
- Developing regulated and/ or process documents with the ability to deliver high quality documentation including technical writing.
- Support the management of Research and Development controlled processes and the creation and/ or revision of associated documentation.
- Responsible for supporting the development of controlled documentation for R&D processes.
- Management of R&D process documentation per required process 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, manuals and related business process documentation in conjunction with Subject Mater Experts.
- Liaison with other members of the QCA group and also the business.
- Management of documents via the established R&D Document Review process using the electronic document repository.
- Track and provide regular updates to process project inventory tools and key points of contact.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Experience in developing regulated or process documents with the ability to deliver high quality documentation including technical writing.
- Sound project management and organisational skills.
- Ability to work independently 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 systems.
- Good working knowledge of Microsoft Word.
- Previous experience in the R&D/ pharmaceutical industry with knowledge of quality and compliance.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA43025 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Contact: Lucy Stendall
- Phone: 01246 457733
- Reference: KA43025
- Updated: 8th August 2018
- Expires: 5th September 2018