BeiGene - Emeryville, CA
posted 6 months ago
The Senior Medical Writer at BeiGene is a pivotal role responsible for the creation, editing, and formatting of clinical regulatory documents that comply with both domestic and international regulatory submission standards. This position requires a high level of attention to detail and the ability to produce high-quality, scientifically accurate documents within strict timelines. The types of documents produced include clinical study reports, clinical study protocols or amendments, investigator brochures, and clinical sections of INDs, NDAs, MAAs, and other regulatory submission documents. In this role, the Senior Medical Writer will work effectively with cross-functional teams to ensure that all documents are consistent and meet the necessary regulatory guidelines. They will be responsible for conducting quality checks on assigned documents before approval and ensuring that documents are routed correctly during the review and approval cycles. The Senior Medical Writer will also manage timelines and maintain communication with team members to ensure that expectations, milestones, and deliverables are met. Additionally, the Senior Medical Writer will review and edit documents authored by both internal and external parties, collaborating with the medical writing group to develop and maintain writing processes, standards, and tools such as SOPs, work instructions, templates, and style guides. They will ensure that all clinical documents adhere to BeiGene's standards and regulatory guidelines, and may also coordinate and manage contract medical writers as needed.