パーソルキャリア株式会社(BilingualRecruitmentSolutions)

パーソルキャリア株式会社 (BilingualRecruitmentSolutions)

Manager, Medical Writing in Oncology specialized company

求人会社名 : 会社名非公開

求人ID : JO-1803-45968_5211

  • 語学(英語)を生かす
仕事内容 Responsibilities:

POSITION Manager, Medical Writing
SUPERVISOR Senior Manager / Associate Director / Director, Medical Writing
DEPARTMENT Medical Writing / Clinical R & D
PREREQUISITES Bachelor with 5+ years of regulatory writing & submissions experience
(BS/BA, Masters and PhD degree in science preferred). Lead of at least 1
submission (i.e., accountable for the preparation of all summary documents).
Responsibilities will include, but are not limited to, the following:

1 In collaboration with other relevant line functions, prepare and give directions - as medical writing lead―for clinical and regulatory documents, including Investigator Brochures, Clinical Study Reports (CTD Module 5), Integrated Summaries of Efficacy and Safety (CTD Module 5), Clinical Summaries of Efficacy (CTD Section 2.7.3) and Safety (CTD Section 2.7.4), Clinical Overview (CTD Section 2.5), Pediatric Investigation Plan, Proposed Pediatric Study Request, Requests of Product Specific Waiver and Confirmation of the Applicability of Class Waiver, applications for Orphan Drug Designations, and responses to health authorities
2 Direct the entire document portfolio required for a project (eg, an NDA submission)
3 Provide direction to team on document content and provide innovative solutions to cross-functional areas
4 Identify resource issues and determine how to allocate resources to meet timelines
応募資格 Skills/KnowledgeRequired:
Extensive experience writing all types of clinical & regulatory documents and with registration dossiers
for worldwide use
Knowledgeable in preclinical development including
勤務地 東京都
Tokyo 23 wards
勤務時間 会社規定に準ずる
年収・給与 1000万円~1500万円
セールスポイント Oncology specialized company

求人会社概要

求人会社名 会社名非公開
概要 This company strives to deliver highly innovative and life-altering drugs for our patients. The vision is is to construct a major global biopharmaceutical organization which concentrates on the discovery, the development, and the marketing of products for oncology and the treatment of other severe and immune conditions.
業種 医療機器

コンサルタントからのメッセージ

"詳細は下記までお気軽にお問合せ下さい。

Koto Ikeda
Consultant
Pharmaceutical
Bilingual Recruitment Solutions
PERSOL CAREER CO., LTD.
Marunouchi Bldg. 27F-28F 2-4-1 Marunouchi
Chiyoda-ku Tokyo 100-6328
Tel: +81-3-6370-7460
Dir: +81-3-6370-8015
koto.ikeda@persol.co.jp
http://igs.inte.co.jp"

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