Senior/ Medical Writer

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

The FTE Medical Writer willserve as an integratedmember ofthe team, deliveringmedical writing services for thedevelopment 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,andsubmission documentssuch as theSummary of Clinical Efficacy and Safety, etc. Emphasis will beplacedon the therapeutic areasofeye health and inflammation; senior-level experience in these areas is preferred.

The FTE Medical Writer will work on a dedicated basis and be embeddedin sponsor’s processes and workflows, including Feedback and Alignment Meetings. In this role, the FTE Medical Writer willparticipate in ongoing project-related activities, such as planning, project discussions, and all required training sessions. The FTE Medical Writer willadopt 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 meetingsor 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.

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.