Senior/ Medical Writer - FSP (M/W/D)

IQVIA Argentina; Zaventem; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

IQVIA is seeking a senior FTE Medical Writer to deliver clinical documents including CTRs, TDOs/CTPs, CTP amendments, Briefing Books, IBs and IB updates, and submission sections for eye health and inflammation programs.

The writer will be embedded in sponsor processes, participate in planning and meetings, and follow sponsor SOPs, EDMS workflows, and formatting checklists to ensure timely, high-quality deliverables. Strong communication and project management skills are essential.

Qualifications

• Bachelor’s degree in a scientific, clinical, regulatory, or related field required.
• Approx 5 years of medical writing experience in biopharma, biotech, or CRO.
• Solid knowledge of ICH, FDA, EMA guidelines across clinical development.
• Ability to lead writing activities for complex documents and provide strategic input.

Responsabilités

• Document management, EDMS setup and document control.
• Review and approval of Statistical Analysis Plans in the EDMS.
• Plan and monitor timelines with trial/project teams.
• Prepare for and attend trial team and submission meetings.
• Draft narratives with appropriate tables and figures.
• Coordinate review cycles and integrate comments from teams.
• Perform QC checks and complete QC documentation forms.

Connaissances

Medical writing

Clinical trial documents

Regulatory submissions

Project management

Cross-functional collaboration

Editing and QC

Communication skills

Formation

Bachelor’s degree in science

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

Outils

EDMS

Microsoft Word

Structured authoring tools

Description du poste

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.