Principal Medical Writer

About the Role

This position serves as a strategic partner in the development of high-quality clinical and regulatory documents, ensuring the efficient flow of information throughout the product lifecycle at BeiGene. You will be instrumental in facilitating the speed of development, submission, approval, and life-cycle management for products within the BeiGene pipeline.

The role encompasses a broad spectrum of document types, including clinical study protocols, investigator brochures, clinical study reports, regulatory briefing documents, and clinical modules for INDs, NDAs, BLAs, and MAAs. Beyond individual authorship, you will act as a mentor to junior Medical Writers, guiding both full-time employees and contractors in best practices and operational standards.

Day in the Life

You will navigate complex writing tasks, managing multiple documents simultaneously while adhering to regulatory guidelines, BeiGene SOPs, and style guides. Your day involves critically analyzing and synthesizing complex information to lead strategy setting for document development in collaboration with study teams. You will identify potential risks, develop mitigation plans, and resolve issues that require departmental discussion.

A significant portion of your time will be dedicated to building strong relationships with study and program teams, understanding how your documents fit within the larger dossier, and voicing impacts on upstream and downstream processes. You will also proactively identify needs for process and tool optimization, contributing to cross-functional and cross-company improvements.

Influence and Collaboration

You will operate with a global Medical Writing scope, guiding study and program teams within defined responsibilities. This includes providing topic sharing on regulatory writing and related knowledge within the department and to cross-functional stakeholders. You will also represent the team at external forums, such as DIA meetings and medical writing communities, to share insights and stay current with industry standards.

Hiring Process

Candidates will be evaluated on their ability to manage complex documentation, lead strategy, and mentor others. The interview process typically involves a review of writing samples and a discussion of past project management experiences.

Equal Opportunity Employer

BeiGene is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.