Senior 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,   clinical   module s of   INDs, NDAs, BLAs, MAAs   and other regulatory   submissions , and   other types of   clinical and regulatory   documents within the working scope of global medical writing .   This position is also responsible for mentoring 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 ).   Proactively leads 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 guide other MWs .   Leads   part of   the creation of document writing template/guidance for all document types   within the working scope .   Leads the maintenance of document writing   template /guidance for all document types   within the working scope .   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), includ ing   those for complex projects.   Be able to guide other MWs.   Proactively identifies the questions/issues/potential risks that require departmental discussion or team discussion .   Proactively identifies the potential risks and makes   a   mitigation plan .   Resolves problems efficiently and skillfully.   B e able to guide other MWs   in these areas.   Builds strong and in-depth 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 guide other MWs and provide suggestions.   Process/Tool Establishment and Optimization :   Proactively identifies needs for process/tool optimization and establishment, and proposes solutions.   Leads departmental process/tool optimization. Leads (part of) departmental process/tool establishment.   Leads part of cross-functional process/tool optimization.   Contributes to cross-function process/tool establishment .   Contributes to 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 other MWs.   Provides   systematic   technical and operational mentorship to 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.   Provides topic sharing on regulatory writing and related knowledge across companies ( eg , meetings of DIA and medical writing communities).   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.     BS with a minimum of   7   years of regulatory document writing (or equivalent) experience, master's with 5+ or PhD/PharmD/MD with a minimum of  3+ 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: $137,100.00 - $182,100.00 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.  P