Principal Medical Writer

BeiGene • Emeryville, CA • 1w ago

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 BeOne 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 BeOne 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.

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.

Education/Experience Required:

MS with a minimum of 4+ years of regulatory document writing (or equivalent) experience.

PhD/PharmD/MD with a minimum of 2 years of regulatory document writing (or equivalent) experience.

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

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.

BeiGene

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