Senior Medical Writer & Project Lead

IQVIA; Zaventem; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

IQVIA seeks a Lead Medical Writer to act as the lead writer on a range of projects, ensuring documents align with SOPs and customer requirements within agreed timelines.

The role involves senior review, negotiating timelines, and providing feedback to junior staff. You will stay current with GCP, drug development, and medical writing practices, collaborating with cross-functional teams.

Qualifications

• Bachelor's degree in life sciences or related field; advanced degrees preferred.
• At least 5 years of relevant senior medical writing experience with CSR/protocols.
• Strong knowledge of GCP, regulatory expectations, and trial documentation.
• Ability to review statistical outputs and identify deficiencies in reports.
• Proven ability to lead projects, manage timelines, and communicate with customers.

Responsabilités

• Lead preparation of assigned documents, confirm scope, templates, specs, and timelines.
• Plan workload, track timelines, and implement customer requests.
• Lead meetings on challenging topics and present standard Medical Writing processes.
• Mentor/train junior staff; deliver internal/external trainings.
• Possibly act as Project Manager for complex Medical Writing projects.
• Manage project finance activities, budgeting, and forecasting hours.
• Propose and approve budgets/costings for routine projects.
• Represent the region/site on Medical Writing initiatives and cross-functional teams.

Connaissances

Leadership

Medical Writing

Project Management

Budgeting

Client Communication

Regulatory Knowledge

GCP Knowledge

Formation

Bachelor's Degree in life sciences

Master's Degree in life sciences

Ph.D. in life sciences

Outils

MS Office Suite

Document Management System

Description du poste

IQVIA seeks a Lead Medical Writer to act as the lead writer on a range of projects, ensuring documents align with SOPs and customer requirements within agreed timelines.

The role involves senior review, negotiating timelines, and providing feedback to junior staff. You will stay current with GCP, drug development, and medical writing practices, collaborating with cross-functional teams.