BeOne Medicines is hiring a Senior Medical Writer

BeOne is hiring a Senior Medical Writer to join our team. In this role, you will be responsible for writing, editing, and formatting clinical regulatory documents that conform to domestic and international submission standards, while meeting critical project timelines.

What You'll Do

• Write, edit, and format clinical regulatory documents such as study reports, clinical study protocols or amendments, investigator brochures, and clinical sections of INDs, NDAs, MAAs and other regulatory submission documents.
• Work effectively with cross-functional groups to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents.
• Ensure assigned documents undergo a quality check before approval and 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.

What We're Looking For

• At a minimum 4 years' relevant industry experience as a regulatory medical writer with a BA/BS degree.
• 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.
• The technical/scientific ability to critically analyze, synthesize, and present complex information in well-constructed documents.
• 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.

Nice to Have

• PhD/PharmD in life sciences.
• Experience in writing clinical sections of INDs, MAAs, and NDAs.
• Working knowledge of drug/biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology.

Technical Stack

• Microsoft Word
• Adobe Acrobat
• Electronic document management systems
• Microsoft Outlook
• Excel
• PowerPoint

Benefits & Compensation

• Compensation: $101,700.00 - $136,700.00 annually + equity: Eligible for discretionary equity awards
• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness
• Eligibility for discretionary equity awards
• Voluntary participation in the Employee Stock Purchase Plan
• Annual bonus plan (Non-Commercial roles)
• Incentive compensation plan (Commercial roles)

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.