Principal Medical Writer

BeOne Medicines • Emeryville, CA • 3h 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 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 :

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, 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:

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