Principal Medical Writer

BeiGene, Ltd.

United States

Remote

USD 119,000 - 159,000

Full time

14 days+

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Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Job summary

BeOne seeks an experienced regulatory medical writer to support development of high-quality clinical and regulatory documents for NDA/MAA submissions and lifecycle management. You will lead document writing, manage timelines, collaborate with study teams, and mentor junior MWs.

Advanced degree in life sciences preferred; MS/PhD/PharmD/MD. Proficiency in Word, Acrobat, EDMS. Willingness to travel; comprehensive benefits and a global oncology focus offered by BeOne.

Qualifications

Advanced degree in life sciences preferred.
Bachelor's with 5+ years regulatory writing experience.
Regulatory writing experience in NDA/MAA submissions.

Responsibilities

Manages regulatory writing tasks and ensures conformance to guidelines and BeiGene SOPs/WIs.
Leads strategy for document development and mentors junior MWs.
Manages timelines for multiple documents and coordinates with study/program teams.
Identifies process/tool optimization needs and helps establish solutions.

Skills

Regulatory writing

Project management

Mentoring

Cross-functional collaboration

Process optimization

Communication

Education

Advanced degree in life sciences (MS/PhD/PharmD/MD) preferred

Bachelor's with 5+ years regulatory writing experience

Tools

Microsoft Word

Adobe Acrobat

EDMS

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 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.

Essential Functions of the Job

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 analysing, synthesising, 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 optimisation and establishment, and proposes solutions. Leads part of departmental process/tool optimisation. Contributes to departmental process/tool establishment. Contributes to cross‑functional and cross‑company process/tool optimisation.

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.

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.

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

Benefits

Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness

Equal Opportunity Employer

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 accommodationsus@beonemed.com.