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

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.