求人名 メディカルライティング

勤務地 Nihonbashi, Tokyo

事業部 開発

雇用形態 正社員


【Purpose & Scope】


【Essential Job Responsibilities】


- Acts as a representative of Medical Writing Japan for one or more project teams and/or GMWrL in development core teams for an early stage global project with extensive supervision of more senior staff

- Contributes to accelerate of development and assurance of product launches in cooperation with more senior staff

- Prepares clinical and regulatory documents, documents intended for submission to healthcare authorities globally and documents for clinical trial data disclosure with general supervision of more senior staff

- Drives the selection and management of vendors for preparation or ensuring quality of clinical and regulatory documents under the guidance of more senior staff

- Proposes revisions of Quality and Procedure documents to promote more efficient operation

- Provides appropriate guidance to more junior staff in document preparation in the projects in which the individual is engaged

【Specific Physical or Environmental Requirements】



- 文章作成・編集に前向きに取り組んで頂ける方。

- 英語でのコミュニケーションに抵抗がなく、外国人との協働に必要な英語でのコミュニケーション能力を有する方(TOEIC 730点以上又は相当する英語力)。

- 領域・分野問わず医薬品の研究・開発・薬事等の業務経験のある方。

- 科学技術論文、各種試験報告書、国内承認申請資料、規制当局提出資料又は類似の文書を製薬企業で業務として作成した経験又は相当する経験のある方。製薬企業で国内申請準備・承認取得関連業務の経験又は承認申請関連業務に強い興味のある方。


- Technical expertise with MS Word, Excel and Acrobat

- Effective oral and written communication skills

- Effective interpersonal skills

- BS in life science area, or equivalent degree


- PhD or MS in life science area, or equivalent degree

- General knowledge regarding pharmaceutics, medical science and statistics in certain therapeutic area

- General writing ability to be utilized in the duties

- Understands most of the overall procedures related to medical writing duties

- General knowledge regarding clinical development

- Overall knowledge regarding GCP, guidelines and regulatory requirements on medical writing

- It is desirable to have one of the following experiences:

--Those who have experience in clinical trial planning and implementation.

--Those who have experience in creating CTD M2 for domestic approval application.

--Experience in creating various materials for submission to European, US or Chinese regulators as Scientific Lead or Contributing Author.

--Those who have experience in creating clinical trial implementation plans as Study Manager.

【勤務地 / Location】

・東京都中央区 アステラス製薬 日本橋事業所 本社

Nihonbashi, Tokyo

【勤務開始日 / Start Date】


Will be decided according to the candidate's flexibility

【契約期間 / Contract Duration】


Not limited to specified period

【試用期間 / Probation Period】


No probation period in principle

【給与 / Salary】




①Base salary: will be decided by the candidate's experience, skill and capability.

②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000~100,000yen, based on the Grade)

③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.

【昇給 / Salary Raise】


Once a year

【賞与 / Bonus】


Twice a year (July, December)

【諸手当 / Allowance】

裁量労働手当、住宅手当、通勤手当 等

Discretionary work allowance, Housing allowance, Commutation allowance, etc.

【勤務時間 / Working Hours】

8:45~17:45(月~木)、8:45~16:00(金)、 専門業務型 裁量労働制



Discretionary Work System

【休日 / Holidays


Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays

【休暇 / Vacation Leave

年次有給休暇、育児休業制度、介護休業制度 等

Annual paid leave, childcare leave system, nursing care leave system, etc.

【福利厚生 / Welfare

雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等

Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System

【お問い合わせ / Contact

アステラス製薬株式会社 採用担当 / Japan Recruiting team, Astellas Pharma Inc.



"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."