Associate Director, Principal Medical Writer
- 採用企業名
- グラクソ・スミスクライン株式会社
- 職種
-
メディカル・バイオ - 臨床開発メディカルライター
- 雇用形態
- 無期雇用
- 勤務地
-
東京都
- 仕事内容
-
...
■Job Purpose:
The Medical Writing is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of clinical trials designs and interpretation of statistically analyzed research data. He/she would be expected to drive and coordinate the process to draft, review and approve written assignments including marketing application submission documents. This role has extensive clinical document expertise and will lead in the implementation of best practices and continuous improvement. He/she has ability to plan and prioritize without supervision.
■Key Accountabilities/Responsibilities:
・Proven track record in writing a range of clinical documents, including regulatory documents, including but not limited to clinical study reports (CSR), protocol, common technical document (CTD) and material to support health authority interactions for China and Japan submissions.
・Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements.
・Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions in China and/or Japan.
・May lead one or more assets and serve as a medical writing point of contact for this/these assets.
・May lead and coordinate a submission or a project as MW submission/project lead to ensure timely delivery of quality documents and contribute to MW strategic documents. If applicable provide oversight to 3rd party MW activities and contribute to contracting process.
・Drive collaboration between China and Japan MWs. Promote leadership behaviors that support GSK values.
・Demonstrated effectiveness in management of projects of increasing scope and complexity.
・High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data.
・Assess trends and patterns in text and statistical data and effectively organizes content and messages in clinical reports and summary documents.
・Review reporting and analysis plans and provide critical input on the content and display of tables.
・Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., ability to use new technology, to work collaboratively between China and Japan teams, to support documents in different therapeutic areas, etc).
・Support Medical Writing-led process improvement initiatives (e.g. simultaneous submission with US/EU and hyper-acceleration), change management, and the implementation of business guidance/working standards.■休日：完全週休二日制, 年末年始
- 求める経験
-
...
【必要な条件Basic Qualification】
■スキル Skill
・Knowledge/understanding of drug development process
・Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research.
・Ability to interpret, describe, and document clinical data clearly and accurately.
・Working knowledge of International Committee for Harmonization (ICH)/Good Clinical Practice (GCP).
・Necessary computer skills and general computer literacy.
・Proven ability to lead matrix teams and deliver high-quality, fit-for-purpose clinical documents through effective collaboration with internal and external stakeholders.
■経験 Experience
・Over 7 years of clinical regulatory writing experience in the pharmaceutical industry, including authoring documents such as clinical overviews, clinical study reports, clinical study protocols, and responses to regulatory authority inquiries.
■学位/資格/語学力 Education/certification/Language
・English and local language skills (verbal and written)
【望ましい条件 Preferred Qualification】
■スキル Skill
・Knowledge of oncology drug development,
・Strategic and logical thinking with strong planning skills.
・Digital fluency and automation approaches that streamline document preparation.
・Project management skills.
・Commitment to high medical writing standards and continuous process improvement.
・Ability to build and maintain good communication and stakeholder relationships to ensure efficient execution of tasks.
・Flexibility and initiative to solve problems and drive progress in dynamic environments.
・Demonstrated negotiation skills with the ability to persuade and influence others (regardless of level) in achieving team objectives.
・Basic knowledge of biostatistics and pharmacokinetics.
■経験 Experience
・Clinical regulatory writing experience in oncology drug development, including authoring documents such as clinical overviews, clinical study reports and responses to regulatory authority inquiries.
・Experience mentoring junior medical writers.
・Experience working in a global medical writing environment.
■学位/資格/語学力 Education/certification/Language
・Minimum Education - Master’s degree or equivalent in a relevant scientific discipline (e.g., life sciences, medicine, pharmacy).
・Preferred Education - PharmD/PhD/MD■職種未経験者：不可
- 想定年収
- 1000万円 - 1800万円
- 語学力
-
英語力：中級以上語学力: 要
