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

IQVIA; Barcelona; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

IQVIA is seeking an FTE Medical Writer to deliver comprehensive clinical writing services across CTRs, TDOs/CTPs, IBs, and submission documents. The role emphasizes eye health and inflammation with senior-level experience preferred.

You will embed in sponsor processes, manage timelines, and lead writing activities, with strong document controls and experience with eDMS systems to ensure quality and regulatory compliance.

Qualifikationen

• Bachelor’s degree in a scientific, clinical, regulatory, or related field required
• Advanced degree (e.g., MSc, PhD, PharmD, MD) preferred

Aufgaben

• Prepare, write, and manage clinical documents (CTRs, TDOs/CTPs, IBs, RAM, and submission documents)
• Coordinate with sponsor, trial teams, and reviewers to meet timelines
• Lead document reviews, QC checks, and approval cycles
• Ensure compliance with global regulatory requirements (ICH, FDA, EMA) and sponsor SOPs
• Utilize EDMS and templates to maintain consistency and quality

Kenntnisse

Medical writing

Regulatory knowledge

Attention to detail

Project management

Cross-functional collaboration

Ausbildung

Bachelor’s degree in science/related field

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

Tools

EDMS

Jobbeschreibung

Frankfurt, Hesse, Germany

Lisbon, Portugal

Brussels, Brussels-Capital Region, Belgium

Belgrade, Serbia

Barcelona, Spain

London, United Kingdom

Madrid, Spain

Full time

R1560755

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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