Principal Medical Writer

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 Clarity Salary Range: $119,300.00 - $159,300.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflec