BeiGene - San Mateo, CA

posted 6 months ago

Full-time - Mid Level
San Mateo, CA
Chemical Manufacturing

About the position

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.

Responsibilities

  • Write, edit, and format clinical regulatory documents that conform to regulatory submission standards.
  • Collaborate with cross-functional groups to produce high-quality, scientifically accurate documents under strict timelines.
  • Ensure assigned documents undergo a quality check before approval and are routed correctly during review cycles.
  • Manage timelines and communicate with team members regarding expectations, milestones, and deliverables.
  • Review and edit documents authored by others, both internally and externally.
  • Develop and maintain medical writing processes, standards, and tools within the medical writing group.
  • Ensure clinical documents adhere to BeiGene standards and regulatory guidelines.
  • Coordinate and manage contract medical writers as needed.

Requirements

  • Minimum of 4 years' relevant industry experience as a regulatory medical writer.
  • BA/BS degree required; PhD/PharmD in life sciences preferred.
  • Demonstrated ability to communicate and write English clearly, concisely, and effectively.
  • Strong project management skills and ability to prioritize tasks and manage multiple projects simultaneously.
  • Excellent interpersonal skills and ability to work collaboratively as a team member.
  • Recent experience in writing regulatory documents such as clinical study reports, protocols, and protocol amendments.
  • Keen understanding of key requirements for regulatory submissions as per FDA and ICH guidelines.
  • Technical/scientific ability to analyze, synthesize, and present complex information in well-constructed documents.
  • Working knowledge of drug/biologics development, clinical research, study design, biostatistics, and medical terminology preferred.
  • Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems.

Nice-to-haves

  • Experience in writing clinical sections of INDs, MAAs, and NDAs is a plus.
  • Proficiency in Microsoft Outlook, Excel, and PowerPoint.
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