New · posted Nov 1
BeOne Medicines · Biotechnology
Principal Medical Writer
- Remote, US
- Remote
- Full-time
- Senior & Principal
The role
BeOne 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.
This position is responsible for providing expertise to support the development of high-quality, fit-for-purpose clinical and regulatory documents to facilitate speed of information during development, submission, approval, and life-cycle management of products in BeiGene pipeline. The clinical and regulatory documents include, but are not limited to, clinical study protocols, investigator brochures, clinical study reports, regulatory briefing documents, and clinical modules of INDs, NDAs, BLAs, MAAs and other regulatory submissions. This position is also responsible for mentoring junior MWs (full-time employees and/or contractors/vendors) as needed.
What you need
Education Required
An advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science is preferred.
Bachelor's with 5+, MS with a minimum of 4+ years of regulatory document writing (or equivalent) experience, or PhD/PharmD/MD with a minimum of 2+ years of regulatory document writing (or equivalent) experience.
Computer Skills
Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel, and PowerPoint, etc.
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.
What you'll do
Document Writing
Manages the assigned writing tasks and ensures that the documents adhere to relevant regulatory guideline(s), as well as BeiGene SOP/WI(s), template(s), and style guide.
Be able to manage multiple documents at the same time, including the complex documents (eg, those with complex content, urgent timeline, or external collaboration). Leads direction and strategy setting (including critically analyzing, synthesizing, and presenting complex information) for document development in collaboration with study team(s), and be able to help other MWs as requested.
Contributes to the creation of document writing template/guidance for the document types listed in the General Description part. Leads part of the maintenance of document writing template/guidance for the document types listed in the General Description part.
Project /Program Management
Navigates through uncertainties to develop and manage timeline of individual documents and multiple documents (supported by different MWs in one project, eg, works as the MW filing lead for an NDA/BLA/MAA submission). Be able to help other MWs as requested.
Be able to identify the questions/issues that require departmental discussion or team discussion. Be able to identify the potential risks, make a mitigation plan, and work to resolve problems. Be able to help other MWs in these areas as requested.
Builds relationship with study team(s) and program team(s) (eg, works as the MW program lead).
Understands the role of own documents within the larger dossier and voices out any impact on upstream and downstream processes. Be able to help other MWs as requested.
Process/Tool Establishment and Optimization
Proactively identifies needs for process/tool optimization and establishment, and proposes solutions.
Leads part of departmental process/tool optimization. Contributes to departmental process/tool establishment.
Contributes to cross-functional and cross-company process/tool optimization.
Training and Mentoring
Leads (part of) the development of new training programs. Provides instructions/trainings (content‑wise/process-wise) to junior MWs.
Provides technical and operational mentorship to junior MWs (full-time employees and/or contractors/vendors).
Influence
Understands the global MW scope and works to guide study team(s) and program team(s) within the defined scope and responsibility following established processes.
Provides topic sharing on regulatory writing and related knowledge within the department (and to cross-functional stakeholders with guidance from line manager/mentor).
Provides topic sharing on regulatory writing and related knowledge across companies (eg, meetings of DIA and medical writing communities) with guidance from line manager/mentor.
Supervisory Responsibilities
None.
Pay and benefits
$119,300 – $159,300 a year
Employer providedSalary Range: $119,300.00 - $159,300.00 annually
Medical
Dental
Vision
401(k)
Paid Time Off
Employee Stock Purchase Plan
Working conditions
Travel
On occasion, as needed.
Equal opportunity, accessibility and legal noticesBeOne Medicines's statements, word for word
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. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 5% below the US median for Clinical Evaluation & Medical Writing roles at this level.
This roleEmployer provided
Senior & Principal roles in the US12 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $119,300 | — | $159,300 |
| All US (middle half) | $131,125 | $146,000 | $178,500 |
This role: BeOne Medicines's own published range. Comparisons: the base pay employers published on open Clinical Evaluation & Medical Writing roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Evaluation & Medical Writing
The general path across 39 open Clinical Evaluation & Medical Writing roles on Regulatory Jobs, with the titles they carry most. Not BeOne Medicines's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 35 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership18
- Documentation and SOPs10
- Regulatory submissions3
- Lab testing and methods1
- Investigations and CAPA1
- Data and digital systems1
- Clinical trial conduct1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
BeOne Medicines on Regulatory Jobs
- 42
- Open roles
- 41
- Distinct roles
- 2
- Locations
By discipline
- Clinical21 50%
- Regulatory11 26%
- Quality9 21%
By level
- Director18 43%
- Manager11 26%
- Senior & Principal9 21%
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Principal Medical Writer at BeOne Medicines
Open until filled. $119K–$159K a year, employer provided.