臨床開発・基礎研究

Manager II, Regulatory Affairs (RA) Therapeutic Area (TA) Group, Regulatory Affairs Japan, is accountable for executing regulatory activities for projects with high complexity and strategic impact, acting as a senior core member and regulatory lead within project teams. This role drives robust regulatory strategies across the product lifecycle, ensures timely and high-quality regulatory deliverables, and maintains full compliance with applicable regulations and company policies.

In addition to project execution, the Manager II supports and develops RA team members, provides technical and strategic guidance, and contributes to team management within and across therapeutic areas, strengthening overall regulatory capability and operational excellence.

Supports the complete clinical/pharmaceutical drug life cycle process (research, development, market access, market supply) by providing strategic planning and execution, including data transformation and all aspects of descriptive, diagnostic, predictive and prescriptive analytics of data related to projects such as clinical trial data, clinical registries and real-world databases. In particular, this includes the provision of analytics tools, outputs and inference as necessary for the specific use case. May act as an ExpMED Product Owner up to substance/asset level and represent ExpMED regarding data science-related aspects at project, asset, or substance level.

クリニカルディベロップメントサイエンティスト（CDS）は，日本での臨床開発のリーダーとして，臨床に関する事項について責任を負い，社内外のステークスホルダーと協働し，医学的，科学的根拠並びに薬事的観点に基づき，新しい医薬品や医療機器を可能な限り早く効率的に患者さんに届けるための臨床開発戦略を立案・管理・実行する。

クリニカルディベロップメントサイエンティスト（CDS）は，日本での臨床開発のリーダーとして，臨床に関する事項について責任を負い，社内外のステークスホルダーと協働し，医学的，科学的根拠並びに薬事的観点に基づき，新しい医薬品や医療機器を可能な限り早く効率的に患者さんに届けるための臨床開発戦略を立案・管理・実行する。

Purpose
As a Study Management Associate III, you will be part of a dynamic, centralized study 
management team that is responsible for the execution of our global clinical trials and 
a key member of the study team. 
The Study Management Associate III works as an independent, contributing member 
of a cross-functional and global partnership to plan, execute and manage one or more 
Phase 0-4 clinical trials under the guidance of the Study Project Manager and SMA 
Manager. The Study Management Associate III works to ensure that assigned studies 
are executed with quality and efficiency, in accordance with timelines and budget to 
support broader company strategic objectives. The Study Management Associate III is 
expected to work in accordance with all AbbVie Ways of Working.
This is a global role and may be located virtually.

Purpose Statement

Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for  our  patients  and  leveraging  advanced capabilities  to  drive  industry  leading  performance. Partners  with  study  teams,  AbbVie  internal  R&D  stakeholders,  investigators,  and  site  staff  for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.

クリニカルディベロップメントサイエンティスト（CDS）は，日本での臨床開発のリーダーとして，臨床に関する事項について責任を負い，社内外のステークスホルダーと協働し，医学的，科学的根拠並びに薬事的観点に基づき，新しい医薬品や医療機器を可能な限り早く効率的に患者さんに届けるための臨床開発戦略を立案・管理・実行する。

•Contribute to Japan clinical development by providing scientific guide from clinical pharmacology aspects.

•Author regulatory documents for submission and for meetings with PMDA closely collaborating with global counterpart and Japan asset team.

•Take a lead on collaboration with cross-functional teams and bring innovations to clinical development and future in clinical pharmacology group.

The Clinical Scientist (CS) in Japan is responsible and accountable for clinical scientific outputs for assigned projects and studies in Japan.

The CS will have accountability for approximately 2 - 4 projects (assets) at any one time and they will be required to work collaboratively alongside Japan Development, Japan Regulatory Affairs, Japan Medical and other J-MDT/VDT colleagues, as well as with global Medicines/Vaccines Development Team (MDT/VDT) and Clinical Sciences members to drive the ongoing success of the projects

• Prepare high-quality and accurate NDA-related documents (CSR, CTD, etc.) in accordance with regulatory requirements based on policies of global R&D and Japan Development.

• Cooperate with the lead-writer for the formulation of strategies such as policy, schedule, budget, etc. for preparation of NDA-related documents as a sub-writer of the project in charge.

ベーリンガーインゲルハイムグループの新規医薬品候補化合物について，その物理化学的、生物学的性質を考慮し、将来グローバル市場で使用される経口固形製剤処方の製剤設計並びに分析方法の研究開発を行っています。また，以下のようなテーマに関係する新技術や創薬シーズについて，日本国内外の大学や企業からの導入や共同研究を視野に入れたオープンイノベーション活動を推進しています。

• 難溶性薬物の経口吸収改善技術

• 製剤設計並びに分析方法開発におけるデジタル化，シミュレーション技術

Purpose:

This position supports the Clinical Trial Patient Safety Organization to achieve its mission of evaluating and ensuring the quality of clinical trial patient safety data by consistent and accurate delivery of high-quality relevant and timely data review.  Contributes to a culture of process improvement, innovation, and cross-functional teamwork aligning with the company vision and strategies.

The Regulatory Affairs TA will be responsible for ensuring first time approval of new products and new indications for existing products through participation in local brand teams.

臨床開発系の職種を経験されている方で、具体的にめざすポジションは決まっていないものの、漠然とキャリアチェンジを考えているという方はご登録ください。これまでのご経験や興味・関心の方向性などを確認しながら将来につながるキャリアをご提案させていただきます。