Senior Medical Writer — Clinical Documents Lead

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

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.