BeiGene - Emeryville, CA

posted 6 months ago

Full-time - Mid Level
Emeryville, 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 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.

Responsibilities

  • Write, edit, and format clinical regulatory documents that conform to regulatory submission standards.
  • Work effectively with cross-functional groups to produce high-quality 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.
  • Collaborate within the medical writing group to develop and maintain medical writing processes, standards, and tools.
  • 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 as a team player.
  • Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel, and PowerPoint.
  • Keen understanding of key requirements for regulatory submissions as stipulated in FDA and ICH guidelines.
  • Recent experience in writing regulatory documents such as clinical study reports, protocols, and protocol amendments.

Nice-to-haves

  • Experience in writing clinical sections of INDs, MAAs, and NDAs is a plus.
  • Working knowledge of drug/biologics development, clinical research, study design, biostatistics, and medical terminology.
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