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| Job Location | Slough |
| Education | Not Mentioned |
| Salary | £40.00 - £55.00 per hour |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Contract, full-time |
*Medical Writing Specialist - Global Pharma -12-month contract - Berkshire* My client is a Global Pharmaceutical company and they have a position available for a Medical Writing Specialist to join their team for an initial 12 - month contract.As the Medical Writing Specialist you will perform quality control (QC) checks of clinical submission documents, thereby contributing to the successful development, registration in key regions, and commercialisation of new drugs and biologic agents.Clinical submissions documents include: Phase 1-4 protocols and clinical study reports (CSRs), summary documents, risk management plans (as needed), patient narratives, and clinical parts of Investigational Brochures, agency meeting briefing packages, INDs, and responses to agency questions, lay summaries, and redacted documents; and other documents that may be assigned.In order to apply for the Medical Writing Specialist contract, you should possess a Bachelors degree and have good experience performing quality checks to medical writing functions. You will have knowledge of medical, pharmaceutical, and clinical research concepts, including a comprehensive understanding of the clinical trial procedures and drug development process.A good understanding of applicable regulations and guidelines (eg, Code of Federal Regulations, European Directive, and ICH) including CTD structure and content, CSR and summary document content is necessary and you will ideally hold a recognised industry qualification in Medical Writing (such as the professional development qualifications provided by the American and European Medical Writing Associations). Excellent communication skills both written and verbal and Strong computer skills; proficiency in MS Office Suite, and EDMS (Electronic Document Management Systems) experience are a must.Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.To apply for this position or if you want to discuss other roles that we are working on, please do not hesitate to contact Roberta Atkins on . Required skills
Keyskills :
Pharmaceutical Medical writing Quality control checks patient narratives summary documents QC Checks clinical/regulaty documents Phase 1-4 protocols clinical study repts CSRs risk management plans Investigational Brochures