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Premier Research Group Limited
,
Reading, Berkshire
Medical Writing Editor
Overview
Job Description
Description Position at Premier Research Group Limited Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Analgesia, Neuroscience, Oncology, Dermatology, Pediatrics, and Rare Diseases. We're looking for a talented and energetic Medical Writing Editor to join our team! This is a very exciting opportunity to join a dynamic and innovative team and grow with a forward-thinking organization that is changing to course of medicine. Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it! As a Medical Writing Editor , you'll have the opportunity to provide technical writing and editing support. You'll review various regulatory and clinical research technical documents, including protocols, clinical study reports, informed consent forms, and investigator brochures. You'll also have Copyeditor duties that focus on proofreading documents for text, content, and syntax consistency so as to help facilitate the successful production and completion of deliverables in a professional and polished manner. You will provide internal QC review of documents as well as document finalization. What you'll be doing: * Provide editing, formatting, and general assistance to members of the Medical Writing team; provide general editing assistance (e.g., grammar, punctuation, spelling, formatting) and quality control checks for CSRs, appendices, and tables and figures; drive the compilation of documents into a final product * Create in-text tables for clinical study reports and inserts hyperlinks/bookmarks as needed * Prepare clinical study reports and related regulatory documents for finalization in accordance with eCTD guidance and FDA PDF specifications. * Ensure timelines are met promptly; take the initiative to be proactive and search out tasks before they are given * Maintains working knowledge of departmental standard operating procedures and FDA/ICH guidelines You'll need this to be considered: * Bachelor's degree or its international equivalent from an accredited institution * Scientific/technical background preferred with 1-2 years of related experience (clinical trials, publishing, writing, or editing), preferably in the pharma/biotech/CRO sector * Working knowledge of ICH and local regulatory authority drug research and development regulations; FDA Guidance Documents/EU Directives/ISO14155 regulations and/or drug/device development; AMA style guidelines; working knowledge of medical terminology * Strong attention-to-detail is a must with analytical skills * Known for being customer-focused in approach to work and communications with the ability to professionally interact with co-workers, handle remote or virtual work/office environment, and respect global time differences * Maintains a positive, results orientated work environment; excellent team player, collaborative and able to build an effective team. * Excellent organizational and time-management skills, able prioritize work to meet deadlines; ability to multitask and work effectively in a fast-paced environment with changing priorities; accountable, dependable and strong commitment. * Expert in Microsoft Office and Adobe Acrobat; excellent typing skills, ability to use templates, and ability to create and manage large electronic files and documents