Associate Director, Medical Writing

General Description:

The Associate Director, Medical Writing is responsible for leading clinical regulatory medical writing activities for BeiGene that conform to domestic and/or international regulatory submission and internal document standards. Clinical regulatory documents include, but are not limited to, clinical study reports, clinical study protocols or amendments, investigator brochures, population pharmacokinetic and exposure-response reports, regulatory briefing documents, and clinical and clinical pharmacology sections of INDs, NDAs, BLAs, MAAs and other regulatory submission documents. The Associate Director, Medical Writing is also responsible for mentoring junior writers and managing direct reports, if applicable.

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Essential Functions of the job:

• Manages clinical regulatory writing activities outlined in the clinical development plans across BeiGene, including those required to meet Corporate Goals.

• Works effectively with cross-functional groups ensure the production of high-quality, scientifically accurate documents under aggressive timelines, and ensures consistency between related documents and among medical writers, translators, and/or QC Specialists

• Develop and maintain medical writing processes, standards, and tools (eg, SOPs, Work Instructions, templates, style guide, etc.). Ensure clinical regulatory documents adhere to BeiGene standards and regulatory guidelines.

• Manages internal staffing and performance management, including hiring, training, coaching and performance reviews.

• Coordinates and manages contractors and outside vendors

• May assist in projections of Medical Writing department budget and resource needs

Qualifications:

• BA/BS degree with. 8+ years of relevant industry experience in a pharmaceutical, biotech, or vendor medical writing position is required. Master's/PhD/PharmD in life sciences preferred.

• Demonstrated ability to communicate and write English clearly, concisely, and effectively

• Experience in writing clinical documents, including but not limited to clinical protocols, protocol amendments, clinical study reports, and clinical sections of INDs, MAAs, BLAs, and NDAs.

• Experience in writing clinical pharmacology documents, including but not limited to, PK reports, population PK and exposure-response reports, integrated summary of immunogenicity, and clinical pharmacology sections of MAAs, BLAs, and NDAs required.

• Understanding of the interdependencies of various contributing functions (eg, regulatory, clinical pharmacology, biomarkers, HEOR)

• Well-organized: ability to prioritize tasks, work simultaneously on multiple projects, and ensure the completion of high-quality documents according to tight timelines and shifting priorities/demands

• Independently motivated with good problem-solving ability

• Excellent interpersonal skills - must have an ability to work well with others in high-pressure situations; a team player

• Strong project management and leadership skills

• The technical/scientific ability to critically analyze, synthesize, and present complex information in well-constructed documents

• Working knowledge of drug/biologics development, clinical research, study design, biostatistics, and regulatory affairs (eg, FDA and ICH guidelines for various scientific documents) is required

Supervisory Responsibilities:

Mentors junior medical writers and may manage staffing and performance, including, but not limited to, hiring, training, coaching, and performance reviews for direct reports. Further, the position may manage the delivery of services by the department's external vendors and consultants.

Computer Skills:

Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and Powerpoint

Travel:

On occasion, 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.