Senior Medical Writer, Clinical Documents (Eye Health)

IQVIA; Brussel Hoofdstad; On-site; EUR 60,000 - 90,000; Full time

Job summary

IQVIA is seeking a highly experienced FTE Medical Writer to deliver clinical documents across CTRs, TDOs/CTPs, IBs and submission materials. You will embed within sponsor workflows and participate in planning, discussions, and training sessions while adapting to sponsor systems and templates.

The role emphasizes writing quality, regulatory compliance, and cross-functional alignment in eye health and inflammation therapeutics, with senior-level experience preferred.

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 biopharmaceutical, biotechnology, or CRO industry; equivalent experience in clinical or preclinical development will be considered
• Strong knowledge of global regulatory requirements and guidelines (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

Responsibilities

• Document management: Set-up and management of clinical document in the 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

Skills

Medical writing

Regulatory writing

Project coordination

Cross-functional collaboration

Education

Bachelor’s degree in a scientific, clinical, regulatory field

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

Tools

EDMS

Microsoft Word

Job description

IQVIA is seeking a highly experienced FTE Medical Writer to deliver clinical documents across CTRs, TDOs/CTPs, IBs and submission materials. You will embed within sponsor workflows and participate in planning, discussions, and training sessions while adapting to sponsor systems and templates.

The role emphasizes writing quality, regulatory compliance, and cross-functional alignment in eye health and inflammation therapeutics, with senior-level experience preferred.