Senior Medical Writer

BeOne Medicines Ltd.; Emeryville (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a Senior Medical Writer to lead the creation, editing, and formatting of clinical regulatory documents in line with regulatory standards.

The role requires collaboration across teams to ensure timely delivery and adherence to BeOne guidelines. You will edit and review documents such as study reports, protocols, and regulatory submissions, ensuring accuracy, consistency, and compliance with FDA/ICH guidelines.

Qualifications

• Strong English writing and communication abilities.
• Able to prioritize multiple projects under tight timelines.
• Independently motivated with problem-solving skills.
• Excellent interpersonal skills and teamwork.
• Experience with regulatory documents (CSRs, protocols, amendments).
• Knowledge of FDA/ICH guidelines.
• Experience with INDs, NDAs, MAAs is a plus.

Responsibilities

• Collaborate with cross-functional groups to produce high-quality documents under tight timelines.
• Ensure quality checks before approval and proper routing during review cycles.
• Manage timelines and communicate milestones and deliverables.
• Review and edit documents, including those authored by others.
• Develop and maintain medical writing processes, templates, style guides, and SOPs.
• Ensure clinical documents adhere to BeOne standards and regulatory guidelines.
• Coordinate and manage contract medical writers as needed.

Skills

English writing

Communication

Prioritization

Independent problem-solving

Interpersonal skills

Team collaboration

Project management

Regulatory writing

FDA/ICH knowledge

Clinical writing

Education

BA/BS degree

PhD/PharmD preferred

Tools

Microsoft Word

Adobe Acrobat

E-document management

Outlook

Excel

PowerPoint

Job description

The Senior Medical Writer is responsible for writing, editing, and formatting clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project timelines. Clinical regulatory documents include, but are not limited to study reports, clinical study protocols or amendments, investigator brochures, and clinical sections of INDs, NDAs, MAAs and other regulatory submission documents.

Essential Functions of the job:

• Works effectively with cross-functional groups to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents
• Responsible for ensuring that assigned documents undergo a quality check before approval, and that documents are routed correctly during review and approval cycles
• Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
• Review and edit documents, including those authored by others both internally and externally
• Collaborate within the medical writing group to develop and maintain medical writing processes, standards, and tools (eg, SOPs, Work Instructions, templates, style guide, etc.)
• Ensure clinical documents adhere to BeOne standards and regulatory guidelines
• Coordinate and manage contract medical writers as needed

Qualifications:

Knowledge and Skills:

• Demonstrated ability to communicate and write English clearly, concisely, and effectively
• Well-organized: ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities/demands
• Independently motivated with good problem-solving ability
• Excellent interpersonal skills; a team player
• Ability to coordinate and manage communications to enable timely reviews from other authors and reviewers and to function as a collaborative team member
• Strong project management skills
• Recent and significant experience in writing of regulatory documents such as clinical study reports, protocols, and protocol amendments
• Keen understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines
• Experience in writing clinical sections of INDs, MAAs, and NDAs is a plus
• The technical/scientific ability to critically analyze, synthesize, and present complex information in well-constructed documents
• Working knowledge of drug/biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
• Ability to comply with company and/or industry style guides and templates
• Excellent attention to detail related to consistency, grammar, syntax, and scientific accuracy
• Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and Powerpoint

Supervisory Responsibilities:

N/A

Computer Skills:

• Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and PowerPoint

Education Required:

• Senior Medical Writer -- at a minimum 4 years' relevant industry experience as a regulatory medical writer, plus a BA/BS degree; PhD/PharmD in life sciences preferre

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.