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“BeiGene” Company Details
| Company Name | BeiGene |
| Rating | 3.2 / 5.0 |
| Job Type | Full-time |
| Job Position | Remote Position |
Medical Writer Job Overview
The MW is responsible for supporting the development of high-quality, fit-for-purpose clinical and regulatory documents for timely submission to regulatory…
What to do in BeiGene company Job
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
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:
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Works effectively with cross-functional groups to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents.
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Supports study team(s) to set direction and strategy for document development with the guidance from line manager/mentor.
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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.
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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
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Demonstrated ability to communicate and write English clearly, concisely, and effectively.
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Well-organized: ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities/demands.
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Independently motivated with good problem-solving ability.
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Excellent interpersonal skills; a team player.
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Ability to coordinate and manage communications to enable timely reviews from other authors and reviewers and to function as a collaborative team member.
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Strong project management skills.
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Recent and significant experience in writing of regulatory documents such as clinical study reports, protocols, and protocol amendments.
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Keen understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines.
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Experience in writing clinical sections of INDs, MAAs, and NDAs is a plus.
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The technical/scientific ability to critically analyze, synthesize, and present complex information in well-constructed documents.
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Working knowledge of drug/biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred.
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Ability to comply with company and/or industry style guides and templates.
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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
Salary Range: $78,600.00 – $108,600.00 annually
BeiGene 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 BeiGene 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.
We are proud to be an equal opportunity employer and we value diversity. BeiGene 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. All employment is decided on the basis of qualifications, merit, and business need.
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