<p>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.</p><div> <div><h3>General Description:</h3></div> <div><p>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 <a href="https://himalayas.app/companies/beigene">BeiGene</a> 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.</p></div> </div><div> <div><h3>Essential Functions of theJob: </h3></div> <div><h3>Document Writing:</h3></div> <div><ul><li><p>Managesthe assigned writing tasks and ensuresthatthe documents adhere torelevant regulatory guideline(s), as well as <a href="https://himalayas.app/companies/beigene">BeiGene</a> SOP/WI(s), template(s), and style guide.</p></li></ul></div> <div><ul><li><p>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.</p></li></ul></div> <div><ul><li><p>Contributes tothecreation of document writing template/guidance forthedocument typeslistedin theGeneral Descriptionpart.Leadspart ofthemaintenance of document writingtemplate/guidance forthedocument typeslistedin theGeneral Descriptionpart.</p></li></ul></div> <div><h3>Project /Program Management:</h3></div> <div><ul><li><p>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.</p></li></ul></div> <div><ul><li><p>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.</p></li></ul></div> <div><ul><li><p>Buildsrelationshipwith study team(s) and program team(s) (eg, works as the MW program lead).</p></li></ul></div> <div><ul><li><p>Understands the role of own documentswithin the larger dossier andvoices outany impact on upstream and downstream processes.Be able to help other