Full-Time Medical Writer

The MW is responsible for supporting the development of high-quality, fit-for-purpose clinical and regulatory documents for timely submission to regulatory authorities. 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. Ensure clinical documents adhere to relevant regulatory guideline(s), as well as BeiGene SOP/WI(s), template(s), and style guide. Contribute to document life-cycle management, including but not limited to correct archival in the system, key message delivery across 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.
• Supports study team(s) to set direction and strategy for document development with the guidance from line manager/mentor.
• Understands the role of own assigned document(s) in the larger dossier and the impact on upstream and downstream processes with the guidance from line manager/mentor.
• Collaborate within team members to develop and maintain medical writing processes, standards, and tools (eg, SOPs, Work Instructions, templates, style guide, etc.)

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.

Supervisory Responsibilities:

None

Computer Skills:

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

Travel:

None

Other Qualifications:

BA/BS degree with a minimum 2+ years of regulatory document writing (or equivalent) experience; Advanced degree in life sciences preferred

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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