Senior Medical Writer - Regulatory & Program Lead

BeiGene; United States; À distance; USD 119 000 - 159 000; Plein temps

Avantages offerts par ce poste

Medical benefits

Dental & Vision

401(k) plan

Paid time off

Wellness program

Equity awards

Employee Stock Purchase Plan

Résumé du poste

BeOne Medicines Ltd. is seeking an experienced regulatory-document writer to support development of high-quality clinical and regulatory documents. You will mentor junior MWs and coordinate with study teams to ensure timely submissions and regulatory compliance.

The role emphasizes project leadership, process optimization, and cross-functional collaboration across development programs, with opportunities for engagement across BeOne platforms and international teams.

Qualifications

• Must manage writing tasks in line with regulatory guidelines and BeiGene SOPs/templates
• Lead strategy for document development with study teams
• Mentor junior MWs and support process improvements

Responsabilités

• Manage writing tasks and ensure regulatory compliance.
• Lead strategy and collaboration with study teams for document development.
• Identify risks and mitigation plans in regulatory writing projects.
• Provide training and mentorship to junior MWs.
• Influence study/program teams within defined regulatory scope.

Connaissances

Regulatory writing

Mentoring

Project management

Cross-functional collaboration

Timeline management

Formation

MS/PhD/PharmD/MD preferred

Bachelor’s with 5+ years regulatory writing

MS with 4+ years regulatory writing

PhD/PharmD/MD with 2+ years regulatory writing

Outils

Microsoft Word

Adobe Acrobat

EDMS

Outlook

Excel

PowerPoint

Description du poste

BeOne Medicines Ltd. is seeking an experienced regulatory-document writer to support development of high-quality clinical and regulatory documents. You will mentor junior MWs and coordinate with study teams to ensure timely submissions and regulatory compliance.

The role emphasizes project leadership, process optimization, and cross-functional collaboration across development programs, with opportunities for engagement across BeOne platforms and international teams.