BeiGene - San Mateo, 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 expertise in writing clinical documents such as study reports, clinical study protocols, investigator brochures, and various regulatory submission documents including INDs, NDAs, and MAAs. The Senior Medical Writer must ensure that all documents meet project timelines while adhering to BeiGene's internal standards and regulatory guidelines. In this role, the Senior Medical Writer will collaborate effectively with cross-functional teams to produce scientifically accurate documents under strict deadlines. This includes managing the quality check process for assigned documents before they are approved and ensuring that they are routed correctly during the review and approval cycles. The Senior Medical Writer will also be responsible for managing timelines and maintaining 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 contributors, ensuring consistency and adherence to regulatory requirements. They will work within the medical writing group to develop and maintain writing processes, standards, and tools, such as SOPs, work instructions, templates, and style guides. The role may also involve coordinating and managing contract medical writers as needed, ensuring that all clinical documents align with BeiGene's standards and regulatory guidelines.