Senior Regulatory Medical Writer
ProClinical are recruiting for a Medical Writer to work at a leading multinational contract research organisation in London. This is an excellent company to work for, whose clients include many of the world's leading pharmaceutical and medical device companies and they employ over 15,000 personnel in over 50 countries.Job Responsibilties: * Write clinical documents for submission to regulatory authorities, including briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy. * Serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. * Serve as the Medical Writing representative on assigned project teams. * Providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. * Coordinate production and distribution of draft and final documents to project team and client.Skills and Requirements: * Experience in writing multiple clinical study reports, and either CTD documents or study protocols. * Preferably experience in a variety of indications, particularly CNS (schizophrenia, depression, Alzheimer’s), renal disease, oncology, dermatology. * Experience with a variety of documents (CSRs, IBs, protocol/amendments, briefing books, HA responses, post-submission safety updates, and preferably submissions [clinical CTD modules]. * Excellent interpersonal, verbal and written communication skills. * Client focused approach to work. * A flexible attitude with respect to work assignments and new learning. * Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail. * Willingness to work in a matrix environment and to value the importance of teamwork. * Team leadership skills. * Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines. * Extensive clinical/scientific writing skills. * Educated to degree level in Life Sciences/Health Related Sciences or equivalent. * Fluency in English (written and spoken) is required.To Apply:Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable. In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website - www.proclinical.com. A full job description is available on request. ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.