Principal Medical Writer

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, clinical modules of INDs, NDAs, BLAs, MAAs and other regulatory submissions, and other types of clinical and regulatory documents within the working scope of global medical writing. This position is also responsible for mentoring MWs (full-time employees and/or contractors/vendors) as needed.

Essential Functions of the J ob:

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,includingthecomplex documents(eg,thosewithcomplex content, urgent timeline,orexternal collaboration).Proactively leads direction and strategy setting(includingcriticallyanalyzing, synthesizing, and presentingcomplex information)for document developmentin collaborationwith study team(s),and be able to guide other MWs.

• Leadspart ofthe creation of document writing template/guidance for all document typeswithin the working scope.Leads the maintenance of document writingtemplate/guidance for all document typeswithin the working scope.

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), includingthose for complex projects.Be able to guide other MWs.

• Proactively identifies the questions/issues/potential risks that require departmental discussion or team discussion.Proactively identifies the potential risks and makesamitigation plan.Resolves problems efficiently and skillfully.Be able to guide other MWsin these areas.

• Builds strong and in-depth relationship with study team(s) and program team(s) (eg, works as the MW program lead).

• Understands the role of own documentswithin the larger dossier and voices out any impact on upstream and downstream processes.Be able to guide other MWs and provide suggestions.

Process/Tool Establishment and Optimization :

• Proactively identifies needs for process/tool optimization and establishment, and proposes solutions.

• Leads departmental process/tool optimization. Leads (part of) departmental process/tool establishment.

• Leads part of cross-functional process/tool optimization.Contributes to cross-function process/tool establishment.

• Contributes to 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 other MWs.

• Providessystematictechnical and operational mentorship to 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.

• Provides topic sharing on regulatory writing and related knowledge across companies (eg, meetings of DIA and medical writing communities).

Supervisory Responsibilities:

• None.

Education Required:

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

• BS with a minimum of 5+years of regulatory document writing (or equivalent) experience, Masters with 4+ 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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.