Publication Medical Lead

Company Overview
Medical Publication Lead - Top Global Pharma Company

Job Description
ジャパン・メディカル・ケイパビリティズ部の mission は、科学的かつ適正な情報提供を通じ、重篤な疾患を持つ患者及び医療従事者の最適な判断に貢献し、患者のよりよい生活の実現に貢献することである。また vision は、1.秩序とリーダーシップに基づき、患者及び医療従事者に適切で解りやすい情報をタイムリーに提供すること、2.変化し続ける医療従事者と患者のニーズに応じたノウハウを継続的に蓄積することによりOperational Excellence を追及すること、である。
製薬企業から社外に向けて発される当社製品関連情報に求められる正確性・妥当性の基準は厳格化の一途をたどっている。このポジションは、厳格にコントロールされたプロセスと手順の下での正確かつ各種ルールに準拠したパブリケーションの作成に責任を有する。
The mission of Japan Medical Capabilities is to contribute to realizing better patients’ life by serving for optimal judgment by the patients with serious disease and HCP through scientific and appropriate information provision. The vision is 1. to deliver appropriate and comprehensive information in a timely manner under order and leadership, 2. to pursue operational excellence by continuously accumulating knowledge in accordance with the changing needs among HCP and patients.
The criteria of the accuracy and adequacy required for product-related information from pharmaceutical companies to external audiences is getting stricter and stricter. Under these circumstances, this position is responsible for the accurate and compliant development of publications with strictly controlled processes and procedures.


役割 (Roles & responsibilities)
Medical Communication

-As Publication Lead, be accountable for the medical/scientific aspects of the scientific manuscripts as well as domestic and international congress presentations and posters developed by company.

-Preside over author's meeting upon the initiation of a publication process by collaborating with internal stake holders.

-Drive medical/scientific discussions within the authors and major stakeholders, and reflect the discussions / consensus to the publication in a scientifically appropriate way.

-Manage each publication projects by tracking the progress, assuring quality, keeping cost within budget and handling issues.

-Collaborate and communicate with internal stakeholders like Medical Lead, HEOR, Development team, WW Publication and content lead and WW Medical Lead as well as external stakeholders like external authors and medical writing vendors.

-Develop and maintain publication plan in company including timing, budget and resources. Report them upon request.

-Standardize the timely, accurate and effective procedure of publications in collaboration with WW Publication and content lead.

-Provide training's to internal and external stakeholders for company publication procedure and backgrounds.

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

-Knowledge of general process of publications, ICMJE (International committee of medical journal editors) is preferable.

-Good Practice and basis of medical writing is preferable.

-Knowledge about Medical Affairs Law, Fair Competition Code (FCC), Promotion Code, Guideline for Clinical Research (MHLW), Guideline for Observational Research (MHLW) and any other applicable regulation in Japan is preferable.

Skills
-Communication skills as a professional in Japanese context.

-Teamwork skills to nurture trust and confidence with internal stakeholders.

Experiences
-First author of publications in English science journal is mandatory Qualifications

-PhD in Pharmaceutical/ veterinarian/ life-science area is preferable. Language proficiency

-Complete level of written Japanese - can understand medical articles and general business documents in Japanese, can write formal Japanese at business setting.

-Complete level of oral Japanese - can have basic medical/ scientific discussions and build an appropriate relationship with internal stakeholders

-Semi-advanced level of written English - can understand medical articles and general business documents in English.

-Semi-advanced level of oral English - can discuss in English, can understand the outline and discussions of a meeting in English.

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