Experienced Medical Writer

Looking for an EXPERIENCED medical writer on a 40hrs/Full-time basis - 12 month contract. PV experience is highly desirable! You will be responsible for delivering high quality scientifically accurate medical documents, clinical study reports, safety and efficacy summaries, regulatory submissions. The main focus of this role will be to ensure effective scientific documentation and quality control processes are implemented to meet regulatory requirements. Required experience: Must have a strong scientific background: a BSc, or higher, in a medical, clinical, or associated scientific specialty Must have 3-5 years previous experience authoring global clinical submissions including, but not limited to, clinical study reports (CSRs), study protocols, informed consent forms (ICFs), protocol amendments, ICF amendments, eCTD modules specifically 2.4 - 2.7), DSURS, PBRERs and signal evaluation reports. Working knowledge of industry guidelines and standards (FDA, EMA, ICH, PMDA) Demonstrable working ability to implement new strategies and processes to ensure best practices. Strong communication skills is a must. Ability to manage any outsourced writing activities and collaborations with external vendors and service providers Exceptional attention to detail Ability to take initiative and work independently to deliver high-quality regulatory documents Versatility and ability to change topics and priorities rapidly in order to simultaneously manage multiple projects Excellent computer skills (especially MS Word, Excel, PowerPoint) Excellent command of the English language and outstanding written and communication skills. To be a best fit for this role you need: Dedication to meet project deadlines in a timely manner Ability to work independently Attention to detail