Sales Applications Specialist Ultrasound The FTE Medical Writer will serve as an integrated member of the team, delivering medical writing services for the development of clinical documents, including Clinical Trial Reports (CTRs), Trial Design Outlines/Clinical Trial Protocols (TDOs/CTPs) and CTP amendments, Briefing Books, Investigator's Brochures (IBs) and IB updates, Biomarker Reports, and submission documents such as the Summary of Clinical Efficacy and Safety, etc. Emphasis will be placed on the therapeutic areas of eye health and inflammation; senior-level experience in these areas is preferred. In this role, the FTE Medical Writer will participate in ongoing project-related activities, such as planning, project discussions, and all required training sessions. Review and approval of the Statistical Analysis Plan in the EDMS Management of timelines including proposal of timelines to trial/project team (based on timelines communicated by sponsor), finalising them after agreement, and updating them as appropriate Preparation, conduct, and documentation of kick-off meetings, e.g. for TDO/CTP, IB or CTR writing Writing of drafts including appropriate in-text tables and figures according to the timelines agreed upon with trial/project team Provision of drafts and management of all review cycles by the trial/project team, reaching consensus on comments/changes, integration of changes into the text, and completion of the Review Documentation Form (as applicable) Initiation and monitoring or conducting of Quality Control (QC) checks as well as completion of the Quality Control Documentation Form (QCDF) Creation and provision of the final document version to the trial/project team Initiation of publishing and pre-archive checks, monitoring and resolution of findings Bachelor's degree in a scientific, clinical, regulatory, or related field required; MSc, PhD, PharmD, MD) preferred Approx 5 years of experience in medical writing within the biopharmaceutical, biotechnology, or CRO industry; Strong knowledge of integral regulatory requirements and guidelines (e.g., Broad understanding of clinical research processes, including study design, data analysis, and regulatory submission requirements Demonstrated ability to lead writing activities for complex documents and provide strategic input to cross-functional teams Strong organizational, time management, and project management skills, with the ability to manage multiple priorities and meet tight deadlines High attention to detail with a commitment to quality, consistency, and scientific accuracy Proficiency in Microsoft Word and document formatting best practices EEO Minorities/Females/Protected Veterans/Disabled #

📌 Veterinario/A Para Mañanas (Barcelona)
🏢 Avinguda Veterinaris Hospital 24h
📍 Barcelona