Senior Medical Writer — Remote Spain

Full time
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.
The FTE Medical Writer will work on a dedicated basis and be embedded in sponsor's processes and workflows, including Feedback and Alignment Meetings. In this role, the FTE Medical Writer will participate in ongoing project-related activities, such as planning, project discussions, and all required training sessions. The FTE Medical Writer will adopt sponsor's systems, tools, and methodologies to ensure seamless collaboration and alignment with internal teams.
**Document management: Set-up and management of clinical document in the Electronic Document Management System (EDMS)
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
FTE Medical Writer will follow the appropriate process as per document type and according to sponsor SOPs
**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 global 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
Experience with electronic document management systems (eDMS) and familiarity with document templates, style guides, and structured authoring tools
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. EEO Minorities/Females/Protected Veterans/Disabled
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