Senior/ Medical Writer

IQVIA; Zaventem; On-site; EUR 70,000 - 100,000; Full time

Job summary

IQVIA is seeking a dedicated FTE Medical Writer to deliver high-quality clinical documents across CTRs, CTPs, IBs, and submission dossiers. The role emphasizes eye health and inflammation with senior-level experience preferred, integrating into sponsor processes and SOPs.

The successful candidate will manage documentation in EDMS, lead cross-functional writing activities, and ensure timely delivery with rigorous QA, formatting, and alignment with regulatory standards.

Qualifications

• Bachelor’s degree in a scientific/clinical/regulatory field required; advanced degree preferred.
• Approx 5 years of medical writing experience in biopharma, biotech or CRO.
• Strong knowledge of global regulatory guidelines (ICH/FDA/EMA).
• Experience leading writing for complex documents and cross-functional input.
• Excellent written and verbal communication; detail-oriented and timely.

Responsibilities

• Document management in the EDMS and preparation of trials documents.
• Review and approval of the SAP within the EDMS and alignment with teams.
• Develop timelines, coordinate trial/project meetings, and track progress.
• Draft and finalize documents; manage review cycles and integrate changes.
• Perform QC checks and complete QC documentation; prepare final versions.
• Publish final documents and conduct pre-archive checks; ensure sponsor SOP adherence.
• Follow sponsor processes and formatting requirements for all document types.

Skills

Medical writing

Regulatory knowledge

Project management

Communication skills

Team collaboration

Education

Bachelor’s degree in scientific/clinical/regulatory field

Advanced degree preferred (MSc/PhD/PharmD/MD)

Tools

Microsoft Word

eDMS

Document templates & style guides

Structured authoring tools

Job description

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.

Tasks Typically Include, But Are Not Limited To

• 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 for and attendance of the required trial team meetings or submission meetings
• Preparation, conduct, and documentation of kick-off meetings, e.g. for TDO/CTP, IB or CTR writing
• Preparation, conduct, and documentation of Results Alignment Meetings (RAM; not applicable for Phase I in healthy volunteer studies)
• 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
• E-approval of final clinical document in the EDMS
• Technical checks after the final draft of initial IBs and IB updates in the EDMS, and by going through a Final Formatting checklist document
• FTE Medical Writer will follow the appropriate process as per document type and according to sponsor SOPs

Qualifications

• Bachelor’s degree in a scientific, clinical, regulatory, or related field required; advanced degree (e.g., MSc, PhD, PharmD, MD) preferred
• Approx 5 years of experience in medical writing within the biopharmaceutical, biotechnology, or CRO industry; equivalent experience in clinical or preclinical development will also be considered
• Strong knowledge of global regulatory requirements and guidelines (e.g., ICH, FDA, EMA) across all phases of clinical development
• 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
• Excellent written and verbal communication skills, with the ability to clearly and accurately present complex scientific and clinical information
• Strong organizational, time management, and project management skills, with the ability to manage multiple priorities and meet tight deadlines
• Proven ability to work collaboratively in a cross-functional, team-oriented environment while also operating independently when needed
• 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. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. 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. We appreciate your honesty and professionalism.