Senior Medical Writer

Veristat; Madrid; On-site; EUR 60,000 - 90,000; Full time

Job summary

Veristat is seeking a full‑time Medical Writer to deliver clinical documents including CTRs, protocols, IBs, and submission documents, with emphasis on eye health and inflammation. The role is embedded in sponsor processes and requires collaboration across trial teams and departments.

The candidate will manage EDMS workflows, lead writing efforts for complex documents, and ensure timely delivery per sponsor SOPs across global regulatory expectations (ICH, FDA, EMA).

Qualifications

• Bachelor's degree in a scientific, clinical, regulatory or related field.
• Approx 5 years of medical writing experience in biopharma or CRO.
• Knowledge of ICH, FDA, EMA guidelines across clinical development.
• Ability to lead writing for complex documents and cross‑functional teams.
• Excellent written and verbal communication.
• Strong organizational and project management skills.
• Proficient in Word, formatting, and templates.
• Experience with eDMS and document templates.

Responsibilities

• Set up and manage clinical documents in the EDMS.
• Review and approve Statistical Analysis Plans in the EDMS.
• Manage timelines with trial/project teams.
• Prepare for and attend trial team meetings.
• Draft and format sections with tables and figures.
• Coordinate review cycles and incorporate comments.
• Perform QC checks and complete QC documentation.
• Submit final documents and support archival checks.
• Ensure e‑approval of final documents per sponsor SOPs.

Skills

Regulatory knowledge

Scientific writing

Project management

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in science/related field

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

Tools

Microsoft Word

eDMS

Job description

Athens, Greece
Lisbon, Portugal
Brussels, Brussels-Capital Region, Belgium
Belgrade, Serbia
Barcelona, Spain
London, United Kingdom
Madrid, Spain
Full time
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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

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