Medical Writer

Site Name: Japan - Tokyo - Akasaka Posted Date: Nov 25 2022 職務の目的および主な業務内容 Job Purpose & Key Responsibilities Job Purpose: 臨床試験の関連文書、規制当局に提出する承認申請資料等を作成する。関連法規、ガイドライン及び社内規定に従い、正確で科学的な文書を遅滞なく作成し、臨床試験の実施及び承認申請・取得に貢献する。 Prepare clinical study documents, submission documents, etc. Provide accurate and scientific documents without delay in accordance with relevant laws, guidelines and internal regulations, and contribute to conducting clinical studies and Japan New Drug Application (JNDA) submission/approval. Key Accountabilities/Responsibilities: 臨床試験に関連する文書の作成 治験実施計画書、同意・説明文書、治験総括報告書、治験薬概要書等 Preparation of clinical study documents Study protocol, Informed consent form, Clinical study report, Investigator's brochure, etc. 規制当局に提出する文書（日本語）の作成 Common Technical Document (CTD)臨床パート、対面助言資料、照会事項回答等 Preparation of submission documents in Japanese Common technical document (Clinical part), Briefing document for PMDA consultation, Response to PMDA question, etc. 上記文書の作成における ストラテジー・key messageの作成、解析計画等の検討 スケジュールの作成及びマネジメント In preparing above documents, Prepare key message, discuss analysis plan Plan and manage document preparation schedule 必要な条件Basic Qualification スキル Skill Common Technical Document (CTD)臨床パート、治験総括報告書、治験実施計画書等、承認申請や臨床試験に関連する文書の読解力 / Good reading comprehension skill of submission / study documents (CTD clinical part, Clinical study report, study protocol,etc.). 社内外の関係者と円滑にコミュニケーションし、文書作成をリードすることができる / Communicate smoothly with internal and external stakeholders and be able to lead document preparation 臨床試験に関する基本的知識 / Basic knowledge of clinical studies 生物統計学、薬物動態学に関する基本的知識 / Basic knowledge of biostatistics and pharmacokinetics 薬事規制、ICHガイドライン等に関する基本的知識 / Basic knowledge of regulatory requirements, ICH guideline, etc. ロジカルシンキング / Logical thinking 基本的なPCスキル（Word、Excel、PDF） / PC skill (Word, Excel, PDF) 経験 Experience One of below conditions is required 製薬企業又はCROにおけるメディカルライティング業務経験（3年以上） 医薬品開発業務又はそれに準ずる業務経験（3年以上）Experience for more than 3 years in drug development or similar business 学位/資格/語学力 Education/certification/Language 薬学部または理学系学部卒以上 / Bachelor's degree in pharmacy or scientific discipline 上級・母国語レベルの日本語の能力/ Advanced or Native level of Japanese fluency ビジネスレベルの英語力（英語の論文・資料およびメールの読み書き、会議等） / Business level of English fluency (Journals & Reading materials, Mails, Meetings, etc.) 望ましい条件 Preferred Qualification スキル Skill CTD臨床パート、治験総括報告書、治験実施計画書等、承認申請や臨床試験に関連する文書の作成能力 / Writing skill of submission / study documents (CTD clinical part, Clinical study report, study protocol, etc.) 経験 Experience 承認申請及び審査対応業務の経験（CTD作成、照会事項対応） / Experience in JNDA submission (CTD preparation), response to PMDA question 臨床開発業務又はそれに準ずる業務経験 / Experience in clinical development or similar business 複数部署の関係者で構成されるチームをリードした経験 / Experience in leading a team of stakeholders from multiple departments GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.