Principal Medical Writer/Associate Director

求人詳細

■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 XXX 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 XXX 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.




#LI-Hybrid

こんな方を求めています

経験・スキル

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.

学歴

大学卒業以上

募集要項

職種

薬事、メディカルライティング

給与

年収 700 〜 1,500万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

就業時間

09:00～18:00

休日休暇

土曜日　日曜日　祝日

保険

健康保険　厚生年金保険　雇用保険

受動喫煙防止措置

敷地内禁煙

特長

女性活躍中, 上場企業, 外資系企業, フレックスタイム制, 完全週休2日制, 土日祝休み, グローバル人材歓迎

業種

医療機器・医療品関連

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