Responsible for creating and revising high-quality medical documents and collaborating with various teams to enhance writing and expedite drug approval processes.
ファイザー社メディカルライターの特長
薬事文書の作成を通じた承認取得への貢献
• 医薬開発部門において、治験総括報告書(CSR )やコモン• テクニカル• ドキュメント( CTD )などの薬事文書を、各種ガイドラインおよび標準作成プロセス( SOP)に準拠して作成します。
科学的かつ論理的な記述により、高品質な文書を提供し、医薬品の承認取得に貢献します。
プロジェクトチームメンバーとの連携による品質向上
• 医薬開発部門のプロジェクトチームに加わり、チームメンバーと密に連携することで文書の品質向上を推進します。レビューやディスカッションを通じて、内容の正確性、論理性、整合性等の確保に努めます。
グローバルとの連携による国際的な活躍
• 世界同時申請プロジェクトにおいては、海外のメディカルライターと協力し、国内のみならず、海外の承認申請資料の作成に貢献します。グローバルな視点を持ち、国際的な薬事戦略の一翼を担います。
臨床試験の透明性確保への寄与
• 臨床試験成績の公開文書や、試験参加者向けの文書を作成することで、臨床試験の透明性向上に寄与します。製薬企業として社会的責任を果たすことを支えます。
専門性の向上と相互成長の促進
• 豊富なプロジェクトポートフォリオの下、多くのプロジェクトでメディカルライターが活躍しています。メディカルライター同士が知識や経験を共有するための勉強会を定期的に開催しており、これらの活動に積極的に参画することで、
高度な専門性をさらに磨くとともに、相互啓発を通じた継続的な成長の機会を得ることができます。
主な業務内容
• CSR や CTD 、当局からの照会事項に対する回答文書などの作成
• 臨床試験成績や申請資料の公開文書の作成
• プロジェクトチームと連携(レビューやディスカッション)し文書の品質向上の推進
• 原資料との整合性や論理性を確認し、文書の品質を管理
• 市販後薬事文書の作成支援
• 論文作成またはその管理(必要に応じて)
• 外部委託業者との協業
• 業界活動への積極的な関与
スキル
コミュニケーションスキル、ネゴシエーションスキル、コーチングスキル
メディカルライティングの専門知識と実務経験
経験
医薬品承認申請資料( CSR 、 CTD )の作成経験があると望ましい
語学力
日本語力(ネイティブレベル)
グローバルメンバーと円滑に業務を進められるレベルの英語力
行動特性
上述に加え、医薬品開発に情熱を持ち、かつ、自ら積極的に成長しようとする意欲のある方
多様な意見を尊重しつつ、自らも意見や提案が出来る方
--------------------------------------------------------------------------------------------------------------------------------
Key Strengths of Medical Writers at Pfizer in Japan
Contribution to Regulatory Approval through Document Preparation
• Within the Clinical Development Department, medical writers prepare regulatory documents such as Clinical Study Reports (CSRs) and Common Technical Documents (CTDs) in compliance with various guidelines and standard operating procedures (SOPs).
By providing scientifically and logically written, high-quality documents, they contribute to the successful approval of pharmaceutical products.
Enhancing Quality through Collaboration with Project Team Members
• Medical writers join project teams within the Clinical Development Department and work closely with team members to improve document quality. Through reviews and discussions, they strive to ensure accuracy, logical consistency, and alignment of content.
Global Collaboration for International Impact
• In global simultaneous submission projects, medical writers collaborate with overseas counterparts, contributing to the preparation of submission documents not only for Japan but also for countries worldwide. They bring a global perspective and play
a key role in international regulatory strategies.
Promoting Clinical Trial Transparency
• By preparing public documents on clinical trial results and materials for trial participants, medical writers help enhance transparency in clinical trials, supporting the pharmaceutical company's commitment to social responsibility.
Advancing Expertise and Mutual Growth
• Within a diverse project portfolio, many medical writers are actively engaged. Regular study sessions are held to share knowledge and experience among writers. Active participation in these activities helps refine advanced expertise
and provides continuous growth opportunities through mutual learning.
Main Responsibilities
• Preparation of CSRs, CTDs, and responses to regulatory inquiries
• Creation of public documents for clinical trial results and submission materials
• Collaboration with project teams (reviews and discussions) to improve document quality
• Ensuring consistency and logical flow with source materials, and managing overall document quality
• Support for preparation of post-marketing regulatory documents
• Manuscript writing or management (as needed)
• Collaboration with external vendors
• Active involvement in industry-related activities
Skills
Communication, negotiation, and coaching skills
Specialized knowledge and practical experience in medical writing
Experience
Preferably with experience in preparing regulatory submission documents (CSR, CTD)
Language
Native-level proficiency in Japanese
Proficient in English, with the ability to collaborate effectively with global team members
Behavioral Traits
In addition to the above, candidates should be passionate about drug development and self-motivated and proactive in personal development.
Open to diverse perspectives and able to contribute ideas and suggestions constructively.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
薬事文書の作成を通じた承認取得への貢献
• 医薬開発部門において、治験総括報告書(CSR )やコモン• テクニカル• ドキュメント( CTD )などの薬事文書を、各種ガイドラインおよび標準作成プロセス( SOP)に準拠して作成します。
科学的かつ論理的な記述により、高品質な文書を提供し、医薬品の承認取得に貢献します。
プロジェクトチームメンバーとの連携による品質向上
• 医薬開発部門のプロジェクトチームに加わり、チームメンバーと密に連携することで文書の品質向上を推進します。レビューやディスカッションを通じて、内容の正確性、論理性、整合性等の確保に努めます。
グローバルとの連携による国際的な活躍
• 世界同時申請プロジェクトにおいては、海外のメディカルライターと協力し、国内のみならず、海外の承認申請資料の作成に貢献します。グローバルな視点を持ち、国際的な薬事戦略の一翼を担います。
臨床試験の透明性確保への寄与
• 臨床試験成績の公開文書や、試験参加者向けの文書を作成することで、臨床試験の透明性向上に寄与します。製薬企業として社会的責任を果たすことを支えます。
専門性の向上と相互成長の促進
• 豊富なプロジェクトポートフォリオの下、多くのプロジェクトでメディカルライターが活躍しています。メディカルライター同士が知識や経験を共有するための勉強会を定期的に開催しており、これらの活動に積極的に参画することで、
高度な専門性をさらに磨くとともに、相互啓発を通じた継続的な成長の機会を得ることができます。
主な業務内容
• CSR や CTD 、当局からの照会事項に対する回答文書などの作成
• 臨床試験成績や申請資料の公開文書の作成
• プロジェクトチームと連携(レビューやディスカッション)し文書の品質向上の推進
• 原資料との整合性や論理性を確認し、文書の品質を管理
• 市販後薬事文書の作成支援
• 論文作成またはその管理(必要に応じて)
• 外部委託業者との協業
• 業界活動への積極的な関与
スキル
コミュニケーションスキル、ネゴシエーションスキル、コーチングスキル
メディカルライティングの専門知識と実務経験
経験
医薬品承認申請資料( CSR 、 CTD )の作成経験があると望ましい
語学力
日本語力(ネイティブレベル)
グローバルメンバーと円滑に業務を進められるレベルの英語力
行動特性
上述に加え、医薬品開発に情熱を持ち、かつ、自ら積極的に成長しようとする意欲のある方
多様な意見を尊重しつつ、自らも意見や提案が出来る方
--------------------------------------------------------------------------------------------------------------------------------
Key Strengths of Medical Writers at Pfizer in Japan
Contribution to Regulatory Approval through Document Preparation
• Within the Clinical Development Department, medical writers prepare regulatory documents such as Clinical Study Reports (CSRs) and Common Technical Documents (CTDs) in compliance with various guidelines and standard operating procedures (SOPs).
By providing scientifically and logically written, high-quality documents, they contribute to the successful approval of pharmaceutical products.
Enhancing Quality through Collaboration with Project Team Members
• Medical writers join project teams within the Clinical Development Department and work closely with team members to improve document quality. Through reviews and discussions, they strive to ensure accuracy, logical consistency, and alignment of content.
Global Collaboration for International Impact
• In global simultaneous submission projects, medical writers collaborate with overseas counterparts, contributing to the preparation of submission documents not only for Japan but also for countries worldwide. They bring a global perspective and play
a key role in international regulatory strategies.
Promoting Clinical Trial Transparency
• By preparing public documents on clinical trial results and materials for trial participants, medical writers help enhance transparency in clinical trials, supporting the pharmaceutical company's commitment to social responsibility.
Advancing Expertise and Mutual Growth
• Within a diverse project portfolio, many medical writers are actively engaged. Regular study sessions are held to share knowledge and experience among writers. Active participation in these activities helps refine advanced expertise
and provides continuous growth opportunities through mutual learning.
Main Responsibilities
• Preparation of CSRs, CTDs, and responses to regulatory inquiries
• Creation of public documents for clinical trial results and submission materials
• Collaboration with project teams (reviews and discussions) to improve document quality
• Ensuring consistency and logical flow with source materials, and managing overall document quality
• Support for preparation of post-marketing regulatory documents
• Manuscript writing or management (as needed)
• Collaboration with external vendors
• Active involvement in industry-related activities
Skills
Communication, negotiation, and coaching skills
Specialized knowledge and practical experience in medical writing
Experience
Preferably with experience in preparing regulatory submission documents (CSR, CTD)
Language
Native-level proficiency in Japanese
Proficient in English, with the ability to collaborate effectively with global team members
Behavioral Traits
In addition to the above, candidates should be passionate about drug development and self-motivated and proactive in personal development.
Open to diverse perspectives and able to contribute ideas and suggestions constructively.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
Top Skills
Csr
Ctd
Global Nda
Jnda
Similar Jobs at Pfizer
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
The Medical Affairs Scientist drives medical strategy, engages with healthcare professionals, develops medical plans, and ensures compliance in scientific communications.
Top Skills:
CommunicationComplianceEnglishJapaneseMedical AffairsPharmacovigilanceScientific KnowledgeStakeholder Engagement
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
The MAS role involves providing medical expertise, developing strategies, and collaborating with healthcare professionals to address medical needs in oncology fields.
Top Skills:
Compliance KnowledgeMedical Expertise
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
The Japan Regulatory Lead formulates regulatory strategies for product approval in Japan, leads negotiations with health authorities, and coordinates with multiple departments for optimal outcomes.
Top Skills:
Jnda Submission DocumentsPmda ConsultationRegulatory Strategies
What you need to know about the Sydney Tech Scene
From opera to comedy shows, the Sydney Opera House hosts more than 1,600 performances a year, yet its entertainment sector isn't the only one taking center stage. The city's tech sector has earned a reputation as one of the fastest-growing in the region. More specifically, its IT sector stands out as the country's third-largest, growing at twice the rate of overall employment in the past decade as businesses continue to digitize their operations to stay competitive.