A fantastic opportunity has arisen for a Director to oversee Medical Writing, collaborating with project teams on the strategy and development of documents. This role is based in Oxford and is an excellent chance to solidify your career as a medical writer.
Lead the Medical Writing efforts and strategy on drug development programs and ensure high quality and on-time writing deliverables in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs) Directly oversee, develop, and manage medical writers or medical writing vendor(s) on multiple programs; provide leadership, coaching, guidance, and mentorship; ensure management and training of external writers/CROs. Directly coordinate, plan, quality check, and execute the preparation or updating of regulated documents for which input (text) is required from different functions or from different study/project team. Communicate program goals and priorities to the medical writers on assigned drug development programs. Plan, coordinate, oversee, and drive clinical filing dossiers with colleagues from Regulatory and the selected 'dossier writing' vendor. Independently plan, write, and edit high-quality and on-time writing deliverables Contribute to the development of global department standards (including templates, style guides, and related processes) and implementation of process improvements. Collaborate with Medical Writing leadership to ensure proper planning and resourcing for upcoming project writing deliverables. Serve as subject matter expert for Research and Development documents and their production, including clinical document strategies within the drug development program.
Skills and Experience
Master's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree and/or professional certification/credentials preferred. 10+ years of experience as a medical writer in the sponsor/CRO setting. Sponsor experience strongly preferred. Experience with leading, planning, writing, coordinating, and overseeing the clinical dossier for global regulatory filings In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process. Successful track record of managing multiple projects in a fast-paced and deadline-driven environment. Impeccable attention to detail and ability to complete writing assignments in a timely manner with minimal oversight. Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
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 contact Oliver Jones on 02038541077 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.