Principal Medical Writer

BeiGene; United States; Remote; USD 119,000 - 159,000; Full time

Benefits offered by this job

Medical benefits

Dental & Vision

401(k) plan

Paid time off

Wellness program

Equity awards

Employee Stock Purchase Plan

Job summary

BeOne Medicines Ltd. is seeking an experienced regulatory-document writer to support development of high-quality clinical and regulatory documents. You will mentor junior MWs and coordinate with study teams to ensure timely submissions and regulatory compliance.

The role emphasizes project leadership, process optimization, and cross-functional collaboration across development programs, with opportunities for engagement across BeOne platforms and international teams.

Qualifications

• Must manage writing tasks in line with regulatory guidelines and BeiGene SOPs/templates
• Lead strategy for document development with study teams
• Mentor junior MWs and support process improvements

Responsibilities

• Manage writing tasks and ensure regulatory compliance.
• Lead strategy and collaboration with study teams for document development.
• Identify risks and mitigation plans in regulatory writing projects.
• Provide training and mentorship to junior MWs.
• Influence study/program teams within defined regulatory scope.

Skills

Regulatory writing

Mentoring

Project management

Cross-functional collaboration

Timeline management

Education

MS/PhD/PharmD/MD preferred

Bachelor’s with 5+ years regulatory writing

MS with 4+ years regulatory writing

PhD/PharmD/MD with 2+ years regulatory writing

Tools

Microsoft Word

Adobe Acrobat

EDMS

Outlook

Excel

PowerPoint

Job description

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.

General Description:

This positionis responsible forprovidingexpertisetosupport the development of high-quality, fit-for-purpose clinical and regulatory documents tofacilitatespeed of information during development, submission, approval, and life-cycle management of products in BeiGene pipeline.Theclinicalandregulatory documents include, but are not limited to,clinical study protocols,investigator brochures,clinicalstudy reports,regulatory briefing documents,andclinicalmodules ofINDs, NDAs, BLAs, MAAsand other regulatorysubmissions.This position is also responsible for mentoringjuniorMWs (full-time employees and/or contractors/vendors)as needed.

Essential Functions of theJob:

Document Writing:

• Managesthe assigned writing tasks and ensuresthatthe documents adhere torelevant regulatory guideline(s), as well as BeiGene SOP/WI(s), template(s), and style guide.

• Be able tomanagemultipledocuments at the same time,includingthecomplexdocuments(eg,thosewithcomplex content, urgent timeline,orexternal collaboration).Leads direction and strategy setting(includingcriticallyanalyzing, synthesizing, and presentingcomplex information)for document developmentin collaborationwith study team(s),and be able to help other MWsasrequested.

• Contributes tothecreation of document writing template/guidance forthedocument typeslistedin theGeneral Descriptionpart.Leadspart ofthemaintenance of document writingtemplate/guidance forthedocument typeslistedin theGeneral Descriptionpart.
  

Project /Program Management:

• Navigatesthrough uncertainties to develop and manage timeline of individual documentsand multiple documents (supported by different MWs in one project,eg, works as the MW filing lead for anNDA/BLA/MAAsubmission).Be able to help other MWsasrequested.

• Be able toidentifythe questions/issues that require departmental discussion or team discussion.Be able toidentifythe potential risks,makeamitigation plan, and work toresolve problems.Be able to help other MWsin these areasasrequested.

• Buildsrelationshipwith study team(s) and program team(s) (eg, works as the MW program lead).

• Understands the role of own documentswithin the larger dossier andvoices outany impact on upstream and downstream processes.Be able to help other MWsasrequested.
  

Process/Tool Establishment and Optimization:

• Proactivelyidentifiesneeds for process/tool optimization andestablishment, andproposessolutions.

• Leads part of departmental process/tool optimization. Contributes to departmental process/tool establishment.

• Contributes to cross-functionalandcross-companyprocess/tool optimization.

Training and Mentoring:

• Leads(part of)the development of new training programs.Provides instructions/trainings (content‑wise/process-wise) tojuniorMWs.

• Provides technical and operational mentorship tojunior 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 (andto 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.

Education Required:

An advanced degree (MS/PhD/PharmD/MD) in life science,pharmacy,medical, orhealth-related science is preferred.

Bachelor’swith 5+,MS with a minimum of4+years of regulatory document writing (or equivalent) experience, orPhD/PharmD/MD with a minimum of2+years of regulatory document writing (or equivalent) experience.

Computer Skills:

Technicalexpertisein Microsoft Word, Adobe Acrobat, and electronic document managementsystems;proficiencyin Microsoft Outlook, Excel,and PowerPoint, etc.

Travel:

On occasion, as needed.

Global Competencies

• 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: $119,300.00 - $159,300.00 annually

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.

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 [e-mail].