Experienced Medical Writer required for Top Global Pharma/ Permanent/ Buckinghamshire
The role would be a (senior) medical writer post supporting global medical affairs and established products. The role supports mostly EU medical affairs, but this role would be primarily supporting US programs under oversight in US. This work would be developing protocols and CSRs (all phases, including observational studies, and regulatory submission/responses), so it would be very varied. We would be looking for someone with a flexible approach to writing and a good scientific understanding Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documentation. Contributes to project plan concerning organization and table layout for a specific document. Ensures that documents meet regulations, and the key messages as defined by the team are clearly and adequately represented. Review study concepts and edit protocols for consistency, progression, structure, and grammar. Review statistical analysis plans and incorporate into clinical study reports. Drive the document preparation process, receive and review primary statistical output, draft and distribute document for review, and compile comments and edits as necessary. Participate in team and client meetings as requested. What is required: Advanced degree in a relevant scientific/clinical/regulatory field preferred Strong background of pharmaceutical industry experience in the clinical/regulatory field Global regulatory submission experience. Excellent writing skills within medical affairs or regulatory. Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences. Knowledge of current requirements and guidelines applicable to submission documents Excellent interpersonal and oral communication skills. Strong knowledge of MS Word, Excel, PowerPoint, and Outlook Ability to prioritize multiple projects For more information please contact Tanzina Guerni on: firstname.lastname@example.org or call me directly on: 01628 493 517 What is offered: Permanent role through DOCS Base salary Pension Private BUPA Healthcare Life Assurance 23 days holiday which increases each year to a max of 27 days Flexibility of home-working 2 days a week.