Principal Medical Writer

Benefits

Additional Information

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 s upport 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 c linical and regulatory documents include, but are not limited to, clinical study protocols, investigator brochures , clinical study reports, regulatory briefing documents, and clinical module s 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 J ob: Document Writing : Manages the assigned writing tasks and e nsures 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 ). L eads direction and strategy setting ( including critically analyz ing , synthesiz ing , and present ing complex information ) for document development in collaboration with study team(s) , and be able to help other MWs as request ed . 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 : Navigate s through uncertainties to develop and manage timeline of individual document s and multiple documents (supported by different MWs in one project, eg , works as the MW filing lead for a n NDA/BLA /MAA submission). Be able to help other MWs as request ed . 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 r esolve problems. B e able to help other MWs in these areas as request ed . Builds relationship with study team(s) and program team(s) ( eg , works as the MW program lead). Understands the role of own documents with in the larger dossier and voices out any impact on upstream and downstream processes. Be able to help other MWs as request ed . 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. Education Required: A n a dvanced 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 Power P oint , etc. Travel: On occasion, as needed. Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. 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 Cl