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  3. Medical Writer

Medical Writer

600 〜 900 ten thousand JPY

  • RGF HR Agent
  • Location: Tokyo
  • Japanese level:Fluent │Required length of experience:Uncategorized
  • Close
Date:2019/11/14~2020/05/12

Job summary

Job category Professional (Consulting / Finance / Real Estate / Professional Services)/Professional Services (Health Care / Welfare / Education / Instruction)
Industry Health Care/ Other Health Care
Employment type Uncategorized
Position level Other
Number of openings 1
Desired entry time -
Required language skill

Japanese (Fluent)

Foreign language competence -
Working hours Others
Welfares / Leave systems
Assistance in visa application -
Number of foreign employees -

Work details

Company Overview
Medical Writer - Top Global Pharmaceutical Company

Job Description
■概要
- Lead the authoring of clinical/regulatory documents and support the performance goals (including quality and timeline) for filing regulatory dossiers in Japan as planned by the R&D Development Teams.
- Establish cooperative partnership with other functions within company and GRD to maintain fully integrated and standardized processes and systems.
- Fulfill the role of Japan Documentation Lead.

■役割
- A senior level scientific writer who creates basic clinical/regulatory documents (e.g. CTD M2.7.6), complex clinical/regulatory documents (e.g. CTD M2.7.3/2.7.4, CSR) and high level clinical/regulatory documents (e.g. CTD M2.5, responses to Health Authority) independently, ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members.
- Coordinate translation of IBs to Japanese.
- Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for clinical/regulatory documents of assigned projects.
- Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.
- Review and edit other clinical/regulatory documents as required.
- Supervise other scientific writers and improves their capabilities in creation of clinical/regulatory documents for Japan.
- Maintain document prototypes and shells.


役割 (Roles & responsibilities)
日本法人、グローバルHQ、共同開発会社の医薬品開発チームと協業し、得られた専門的なコメントやアドバイスを元に、臨床試験の結果に科学的・医学的解釈を加えながら、CTD M2.5、M2.7.3/2.7.4、M2.7.6等の薬事文書を作成する。
上記文書作成に際し、スケジュール作成・管理を行う。
必要に応じ、他の関連文書(機構相談資料、治験実施計画書、治験総括報告書等)をレビューする。

Requirements
■必要な知識/スキル (Required knowledge/skills)

- Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities.

- Demonstrated strong writing skills both in Japanese and in English, preferably in authoring and leading the production of clinical/regulatory documents for submission to PMDA.

- Ability to analyze and interpret complex data from a broad range of scientific disciplines.

- Experience in authoring clinical/regulatory documents, including high‐level CTD Module 2 clinical summaries, and participation in at least one major JNDA filing.

- Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.

- Working knowledge of a document management system.

- Skills to appropriately manage CROs or translation vendors.

- Skills to read scientific documents in English and communicate with the global members.

- MS/BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent.

必要な知識/スキル (Required knowledge/skills)
製薬企業 開発部門において、3~5年以上の臨床又は薬事関連文書の執筆経験(臨床試験の立案、機構相談資料作成、1つ以上の申請業務等)、若しくは同等の知識・経験を有する者
国内外の規制要件やガイドラインに関する知識
英文リーディング及びライティング・スキル
海外の開発スタッフとのメールや電話会議でのコミュニケーション
臨床試験の結果(データ)の分析・解釈
クロスファンクショナルなチームメンバーとの協働に必要な、プランニング、タイムマネジメント、コーディネーション等のスキル
CROや翻訳ベンダーのマネージメント経験

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Name of person in charge of hiring:

Medical Writer

RGF HR Agent

600 〜 900 ten thousand JPY

Close

Company overview

RGF HR Agent Medical Writer RGF HR Agent Medical Writer

RGF HR Agent

Human Resources / Education / Consulting / Professional Services /Staffing / Recruiting

RGF (Recruit Global Family) is the overseas corporation of Recruit Holdings Co., Ltd., Japan's largest talent comprehensive service and information service group enterprise, has started for more than 50 years, based on excellent business philosophy and management experience. Transcend national borders, we will discover new opportunities and possibilities worldwide.
RGF HR Agent provides solid support for the hiring activities of companies and the job-hunting activities of applicants as a general HR service company.
We provide not only regular recruitment but also RPO (Recruitment Process Outsourcing), contracts and so on. We deliver comprehensive services that could only be offered by RECRUIT=RGF, which is number one in Japan in the field of talent introduction, temporary staffing and recruitment information advertising. Having thoroughly met the needs of leading companies in Japan, we will also provide our consummate, high-quality services overseas. RECRUIT=RGF, which is number one in Japan, will continue taking on the challenge of becoming number one in the world.

JAPAN: RGF HR Agent Japan (CDS)
Address: 東京都渋谷区広尾1-13-7恵比寿イーストビル2F
TEL (+81)3-6422-4400
Website: http://www.rgf-hragent.asia/en/japan

CHINA: RGF HR Agent (Shanghai)
Address: 上海市淮海中路8号 蘭生大厦9F
TEL (+86) 21 5331 8000
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Suzhou)
Address: 蘇州市工業園区蘇州大道西1号 世紀金融大厦1615室
TEL (+86) 512 6262 3595
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Beijing)
Address: 北京市朝陽区東三環中路39号建外SOHO,A座902室
TEL (+86) 10 5869 0121
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Tianjin)
Address: 天津市和平区南京路189号津汇広場一号楼1106单元
TEL (+86) 22 2331 1169
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Dalian)
Address: 大连市高新技术产业园区黄浦路537号(七贤路)泰德大厦811室
TEL (+86) 411 8445 7095
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Guangzhou)
Address: 广州市天河区林和西路161号 中泰国际广场A塔1309室
TEL (+86) 20 8527 4585
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Shenzhen)
Address: 深圳市罗湖区嘉宾路2018号深华商业大厦2507室
TEL (+86) 755 8237 5208
Website: http://www.rgf-hragent.asia/china

HONGKONG: RGF HR Agent Hong Kong Limited
Address: Unit 2206, 22/F, Wu Chung House, 213 Queen’s Road East, Wan Chai, Hong Kong
TEL (+852) 2537 2557
Website: http://www.rgf-hragent.asia/en/hongkong

VIETNAM: RGF HR Agent Vietnam Co., Ltd.
Address: RM903 Central Plaza 17 Le Duan St., Dist 1 Ho Chi Minh City
TEL (+84) 8 3911 5800
Website: http://www.rgf-hragent.asia/en/vietnam

THAILAND: RGF HR Agent Recruitment (Thailand) Co., Ltd.
Address: 689 BHIRAJ TOWER at EmQuartier, 23rd Floor, Room No. 2304-2306 Sukhumvit Road, North Klongton Sub-District, Vadhana District, Bangkok 10110
TEL (+66)2-021-0333
Website: http://www.rgf-hragent.asia/thailand/

SINGAPORE: RGF HR Agent Singapore Pte. Ltd.
Address: 71 Robinson Road #05-04 Singapore 068895
TEL (+65) 6221 7437
Website: http://www.rgf-hr.com.sg/

INDIA: RGF Select India Private Limited
Address: 704-705-706, 7th Floor, Vatika City Point, MGRoad, Gurgaon 122002
TEL (+91)124 4139711
Website: http://www.rgf-hragent.asia/en/india

INDONESIA: PT. RGF Human Resources Agent Indonesia
Address: Jakarta Office: Graha Pratama, P1F (21F), Jl. M.T.Haryono Kav. 15, Jakarta 12810, Indonesia
TEL (+62) 21 8378 2866
Website: http://www.rgf-hragent.asia/en/indonesia

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