Emeryville, CA, 94662, USA
45 days ago
Director, Therapeutic Area Lead, Medical Writing
**General Description:** The role will provide leadership to BeiGene MW department staff (full-time employees and/or contractors) to ensure timely delivery of high quality, fit-for-purpose clinical and regulatory documents within the MW department scope of work that accurately reflect BeiGene standards and global, regional, and local regulatory requirements. Within the TA Lead’s therapeutic area of responsibility, engage key stakeholders across functional teams to drive collaboration and share best practices and strategic input that are relevant to the MW context **Essential Functions of the job:** Project/Program Management for Deliveries + In partnership with global MW head, develop and maintain governance channel for the TA of responsibility. This governance includes operational oversight and pathways for appropriate escalation of issues; + Keep abreast of the development pipeline and compounds for the TA of responsibility; + Collaborate with assigned program leads to oversee MW issues for document development strategies in the TA of responsibility; + Ensure the MW team’s decisions, positions, and key messages are consistently communicated to all stakeholders and are reflected across programs in the TA of responsibility; + Collaborate with MW department Project Managers/Coordinators for resource assignment to meet project needs; + •Accountable for decisions and solving problems to ensure that fit-for-purpose documents are completed with high quality within allocated timelines and resources Processes/Tools Establishment and Optimization + Implement best practices and tools (eg, document templates) and identify any needs for their revision/creation; + Lead/participate in optimization, creation, or update of processes, templates, and associated guidance tools to enhance operational excellence; + Ensure the consistency of processes/tools/best practices across programs within the TA of responsibility; + Provide feedback and support to key activities in productivity programs or continuous improvement initiatives that are led by direct reports as needed. Team Development + Manage internal staffing and conduct performance management, including hiring, training, coaching, and performance reviews; + Lead/participate in the MW talent development plan, such as the understanding of medical/scientific background and applicable guidelines (eg, regulatory, industry); + Foster a team culture in line with the corporate culture and MW mission & vision of excellence, non-hierarchical teamwork, and an environment of mutual respect regardless of experience, geographical locations, and roles and responsibilities. Strategy + Contribute to overall department development strategies (eg, adjusting / expanding business scope, creation of new role), especially for the strategy and plan of responsible therapeutic area; + Contribute to the planning of MW resource to ensure necessary resource for the project needs under responsible therapeutic area and identify resource constraints that may affect timely delivery and engage in proactive contingency planning; + Ensure program/team needs are communicated for budget considerations; Partnership/Collaboration + Establish and maintain a collaborative relationship with both internal and external partners that enables the team to work efficiently and effectively; + Promote the interactions between GMW and cross-functions that could enable GMW to better meet company needs; **Qualifications:** **Education/Experience:** Advanced degree (MS/ PharmD/ PhD/ MD) in life science / pharmacy / medical / health-related science (or comparable years of MW experience) is preferred. Ten+ years of relevant industry experience in a pharmaceutical, biotech or vendor medical writing position is required with a Bachelor's Degree. Previous managerial experience is required. **Computer Skills:** Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and Powerpoint **Travel:** As needed All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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