■ 職務内容 / Job Description

Clinical Regulatory Writer (CReW) is responsible for the authoring of clinical-regulatory documents and submission packages that communicate the evidence base of product knowledge in a credible, consistent and compliant way.
CReW leads the authoring of the clinical parts of documents such as CSP / MICF / CSR / IB / CTD / Regulatory defences, in line with the project communication strategy, and ensure quality and efficiency in delivery.

CReW also leads or contributes the authoring of the clinical parts of the briefing documents for PMDA consultations to improve communication quality of documents. CReW reviews other clinical documents with the purpose of facilitating the translation of Target Product Claims into a fully-supported proposed product label, and to improve communication quality of documents.

■休日：完全週休二日制, 年末年始

■ 職務内容 / Job Description
Clinical Regulatory Writer (CReW) is responsible for the authoring of clinical-regulatory documents and submission packages that communicate the evidence base of product knowledge in a credible, consistent and compliant way.
CReW leads the authoring of the clinical parts of documents such as CSP / MICF / CSR / IB / CTD / Regulatory defences, in line with the project communication strategy, and ensure quality and efficiency in delivery. For CSP/MICF/IB, CReW centralize and coordinate those developments using external vendors across clinical studies.
CReW also leads or contributes the authoring of the clinical parts of the briefing documents for PMDA consultations to improve communication quality of documents. CReW reviews other clinical documents with the purpose of facilitating the translation of Target Product Claims into a fully-supported proposed product label, and to improve communication quality of documents.

■休日：完全週休二日制, 年末年始

・関連部署及び外部業者との調整、進捗及びスケジュール管理
・臨床開発関連文書作成 (試験実施計画書、同意説明文書、治験薬概要書等、治験総括報告書、CTD等)
・開発関連文書作成時のQC　等

■休日：完全週休二日制, 夏季休暇, 年末年始

【職務概要】
医薬品開発における下記メディカルライティング業務をお任せいたします。
※一部、ご経験に応じて非臨床パートをご担当頂く場合がございます。

【具体的には】
・治験実施計画書の作成
・治験総括報告書の作成
・医薬品の承認申請資料（CTD：コモンテクニカルドキュメント）の作成（臨床パートのみ）
・治験薬概要書の作成
・上記作成ドキュメントのレビュー
・当局対応（臨床パートのドキュメント作成、レビューまたはコンサルティング等）
・規制要件を満たす文書作成全般のコンサルティング
・経験の浅いメンバーへの適切な指導、及びメンバーの成長への貢献

Principal Medical Writer/Senior Medical Writerの場合には、プロジェクトチームのMedical Writingパートにおけるリード業務も期待いたします。

■休日：完全週休二日制

Major Accountabilities
1. To author, review and/or independently manage multiple concurrent high quality clinical and safety documents complex Clinical Study Reports (CSR), complex submission documents [clinical portions of the Common Technical Document (CTD)]), other documents for health authorities (e.g., Briefing Books,answers to questions, PMS and re-examination related documents).
2. Extended member of Japan Project Team (JPT) and extended member of Integrated Clinical Trial Team (iCTT). Core member of Japan Submission Team (JST).
3. Strategic input into planning of data analyses and presentation (statistical analysis plan review and meetings) used in CSRs, submission documents and/or answers to questions.
4. Documentation expert in JPTs and JSTs to ensure compliance of documentation to internal company standards and external regulatory guidelines. Provide authoritative content and strategic expertise for clinical portions of the CTD.
5. Lead Writer for large and/or complex programs ensuring no submission-critical issues including consistency between documents for assigned programs.
6. Lead Writer for complex submissions, actively contributing to key messaging and pooling strategy, providing expert content guidance for clinical portions of the CTD, and ensuring compliance of documentation to internal company standards and external regulatory guidelines.
7. Lead process improvement in RWS and cross-functional initiatives and/or activities.
8. Identify training needs to foster high level of performance within RWS. Coach/mentor and/or train less experienced writers.
9. Leader in cross-functional communication to optimize feedback and input towards high quality documents.
10. Maintain audit, SOP and training compliance.
11. Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
12. 100% timely delivery of all training requirements including compliance.

■休日：完全週休二日制

Major Accountabilities
1. To author, review and manage high quality clinical documents and safety documents: complex　Clinical Study Reports (CSR), submission documents [clinical portions of the Common Technical　Document (CTD)], other documents for health authorities [e.g., Briefing Books (BB), answers to questions,PMS and re-examination related documents].
2. Extended member of Japan Project Team (JPT) and Integrated Clinical Trial Team (iCTT). Core　member of Japan Submission Team (JST).
3. Major contributor to planning of data analyses and presentation used in CSRs and submission　documents.
4. Documentation specialist in iCTTs and JSTs to ensure compliance of documentation to internal　company standards and external regulatory guidelines. Provide content expertise and guidance for clinical　portions of the CTD.
5. Lead Writer for submissions, contributing to key messaging and pooling strategy, providing content　guidance, and ensuring compliance of documentation to internal company standards and external　regulatory guidelines.
6. Contribute to process improvement in RWS and/or cross-functional initiatives or activities.
7. Coach and/or mentor less experienced writers.
8. Leader in cross-functional communication to optimize feedback and input towards high quality　documents.
9. Maintain audit, SOP and training compliance.
10. Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
11. 100% timely delivery of all training requirements including compliance.

■休日：完全週休二日制

【Job Description Summary】
To manage business and operational activities of local regulatory writing (RW) to ensure timely production of high quality clinical documentation.
To ensure compliance with global RW strategy and implementation of technical activities & strategies according to internal and external guidelines and business objectives.
To coach, mentor and train less experienced writers.

【Job Description】
■Major Accountabilities
・Business and operational management of local RW.
・Manage quality, timeliness, efficiency and high scientific standards for written documents produced by the local RW; Clinical Study Reports (CSR), Common Technical Document submission documents (clinical overviews, summaries of clinical efficacy and safety), other documents for health authorities (e.g., Briefing Books, answers to questions, PMS and re-examination related documents).
・Act as documentation consultant to other line functions in GDD-J and more widely.
・Lead development of document templates, documentation-related processes and strategies by close interaction with global counterpart.
・Participate in priority setting, workload distribution and resource planning to ensure adequate assignment of writing resource to projects.
・Coordinate outsourcing of RMW activities by acting as liaison between internal vendor management and internal customers
・Contribute to the development of the RW organization through interactions within management team and across functional areas.
・Recruit talent, manage performance (set objectives, review performance and plan compensation).
・Identify training needs to foster high level of performance within RWS. Coach/mentor and/or train less experienced writers.
・Maintain audit, SOP and training compliance.
・Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
100% timely delivery of all training requirements including compliance.

■Key Performance Indicators
・Delivery of high quality clinical and safety documents in time and in compliance with internal and external standards, according to RWS metrics.
・Completion of an adequate volume of work (taking into account complexity) per year in accordance with the Key Performance Indicators.

■Job Dimensions
・Number of associates:
Can act as operational and functional manager (head) for Regulatory Writing
Indirect: matrix management of cross-functional teams.

・Financial responsibility:
Internal costs in RW and external costs for project related activities in documentation area

・Impact on the organization:
Timely preparation of high quality clinical documents supporting pharma/oncology registrations.
Contributor to cross-functional process improvement.

■休日：完全週休二日制

【Job Purpose】
The Medical Writing Optimization Lead is responsible for driving innovation, enhancing capability development, and managing capacity within the Asia medical writing team. This role will focus on optimizing processes, improving efficiencies, adopting digital solutions and ensuring the team is equipped with the necessary skills and resources to meet the evolving needs of the organization. The ideal candidate will have a strong background in medical writing, a passion for innovation, and proven experience in leadership and strategic planning.

【Key Responsibilities】
■Innovation:
・Identify, prioritize and implement innovative solutions to improve the quality and efficiency of medical writing processes.
・Stay abreast of industry trends, emerging technologies, and best practices to drive continuous improvement.
・Collaborate with cross-functional teams to integrate new tools and technologies into the medical writing workflow

■Capability Development:
・Assess the current capabilities of the medical writing team and identify areas for development.
・Design and facilitate training programs to enhance the skills and knowledge of team members.
・Foster a culture of continuous learning, digital fluency and professional growth within the team.

■Capacity Management:
・Monitor and manage the workload of the medical writing team to ensure projects are completed on time and within budget.
・Develop and implement resource allocation strategies to optimize team productivity.
・Collaborate with project managers and other stakeholders to forecast future capacity needs and plan accordingly.

■Leadership:
・Provide guidance, mentorship, and support to medical writers, fostering a collaborative and high-performing team environment.
・Establish dashboard and drive the continuous performance improvement.
・Lead by example, demonstrating a commitment to excellence and continuous improvement.

■Process Improvement:
・Evaluate existing medical writing processes and identify opportunities for optimization.
・Develop and implement standardized procedures and best practices to enhance efficiency and consistency.
・Track and report on key performance metrics to measure the impact of process improvements.

■休日：完全週休二日制, 年末年始

製薬企業の営業担当（MR）が病院訪問時に使用する医療用医薬品のパンフレット・その他販促資材の企画、制作、編集を担当します。
■具体的な業務内容:　
薬の製品情報概要（医薬品のパンフレット）や各種学術冊子などのプロモーション資材の原稿作成をご担当いただきます。ＭＲ向け資料がメインとなります。
与えられた情報を文章に書き起こすだけではなく、医学文献や専門書を調べ、ドクターやその他医療関係者に取材し、総合的に情報収集を行い、原稿を作成していただきます。プロモーションコードや製薬企業側の意向、エンドユーザーである医師の意向を汲み取りながらの原稿を作成し、患者さんが安心して薬を飲めるような販促資料・説明資料に仕上げていただきます。

商品分野は幅広くご担当いただくので、様々な知識を得ることができます。
※OJT研修あり

■休日：週休二日制, 土, 日, 祝日, 夏季休暇, 年末年始

水産や畜産向けワクチン、抗菌剤、動物用医薬品などの研究開発業務
・動物用医薬品等に関わる製品開発及び各種試験、データのまとめ
・薬事に関する申請資料の作成
・試験魚の飼育など

水産、畜産関係の飼料メーカーから販売代理店、養殖業者や畜産農家にいたる様々な顧客ニーズに合わせた研究開発を担っていただきます。

■休日：完全週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始