Director, Medical Writing & Regulatory Submissions Lead

GSK; Waver; Hybrid; EUR 119,000 - 199,000; Full time

Benefits offered by this job

Hybrid working model

Job summary

GSK is seeking a Director Medical Writing Asset Lead to shape clinical documentation strategy for one or more assets, including Hepatology, and to drive global regulatory submissions with a high level of coordination and leadership.

You will design fit‑for‑purpose documents, lead authorship on submissions, mentor teams, and promote process improvements while maintaining a strong focus on accelerated timelines and regulatory compliance.

Qualifications

• PhD, PharmD, MPH, MSc, or other post‑graduate degree.
• Substantial experience in clinical regulatory writing and regulatory submissions in pharma with a proven track record.
• Strong experience in project management, planning, communication, and matrix leadership.

Responsibilities

• Provide medical writing strategy for one or more assets through lifecycle.
• Lead matrix teams in planning and production of clinical documents with CROs/contractors.
• Plan and deliver large submissions, optimize timelines, ensure global regulatory alignment.

Skills

Clinical Development

Medical Writing

Regulatory Submissions

Project Leadership

Regulatory Guidelines

Education

PhD/PharmD/MPH/MSc or equivalent

Job description

GSK is seeking a Director Medical Writing Asset Lead to shape clinical documentation strategy for one or more assets, including Hepatology, and to drive global regulatory submissions with a high level of coordination and leadership.

You will design fit‑for‑purpose documents, lead authorship on submissions, mentor teams, and promote process improvements while maintaining a strong focus on accelerated timelines and regulatory compliance.