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Senior Director, Therapeutic Area Lead, Medical Writing - San Mateo, United States - BeiGene
Description
General Description:
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, regulatory briefing documents, and clinical sections of INDs, NDAs, BLAs, MAAs and other regulatory submission documents. This person will be responsible for the management, planning and direction of a team of full-time employees and/or contractors, consisting of medical writers, document specialists, and/or QC Specialists to support the planning and development of fit-for-purpose, high quality strategic documents in the context of the clinical development plan for all assets within a therapeutic area.
Essential Functions of the job:
Works effectively with cross-functional groups ensure the production of high-quality, scientificallyaccurate documents to support the clinical development of assets across the therapeutic area of responsibility, and ensures consistency between related documents and among medical writers, translators, document specialists, and QC Specialists.
Works with other members of the MW LT to 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.
May assist in projections of Medical Writing department budget and resource needs.
Manages internal staffing and performance management, including hiring, training, coaching and performance reviews.
Coordinates and manages contractors and outside vendors.
Qualifications:
BS Degree with 12 years of overall experience is required; MA/MS/MBA with 10 plus years of overall experience or a PhD/PharmD with 6 plus years of overall experienceand is preferred.
Demonstrated ability to communicate and write English clearly, concisely, and effectively.
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.
Experience in writing clinical protocols, protocol amendments, clinical study reports, and clinical sections of INDs, MAAs, BLAs, and NDAs.
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:
Supervises and guides the development of direct reports as well as cross-matrix supervision of MWs assigned to support documents within the assigned therapeutic area.
Further, the position will manage the delivery of services by the departments external vendors.
Computer Skills:
Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and Powerpoint.
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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