メディカル・バイオ／金属・素材の求人・転職情報

【Role Overview】
The Medical Science Liaison (MSL) is a field-based scientific expert responsible for advancing scientific exchange, evidence generation, and external stakeholder engagement in ophthalmology. This role is responsible for high quality data discussions and support of investigator-initiated trials (IITs), operating independently of commercial promotion. As a novel role within the organization, the MSL also contributes to shaping medical engagement models appropriate for ophthalmic device innovation.

【Duties and Responsibilities】
・Establish and maintain peer to peer scientific relationships with ophthalmic surgeons, academic investigators, and key opinion leaders.
・Lead unbiased scientific discussions related to clinical data, surgical outcomes, and evolving standards of care in ophthalmology.
・Support the evaluation, initiation, and management of Investigator-Initiated Trials (IITs) in compliance with regional and/or local regulations and internal governance.
・Identify unmet medical needs and scientific data gaps and communicate actionable scientific insights to internal stakeholders.
・Support post market research, real world evidence generation, and registry activities where applicable.
・Provide scientific input into medical education initiatives and non-promotional training programs.
・Represent the company at scientific congresses, advisory boards, and academic meetings.
・Collaborate cross functionally to ensure alignment between medical strategy, clinical evidence, and regulatory requirements.
・Ensure all activities adhere to applicable laws, regulations, and company SOPs governing Medical Affairs activities.

【Authority】
The Medical Science Liaison (MSL) is authorized to:
・Independently engage in non‑promotional, scientific exchange with healthcare. professionals, investigators, and academic stakeholders within the defined therapeutic and technological scope.
・Respond to unsolicited scientific inquiries using approved data, peer‑reviewed literature, and fair‑balanced scientific information, in accordance with company SOPs and local regulations.
・Exercise professional judgment to prioritize external scientific engagements and allocate field time based on medical strategy and unmet scientific needs.
Identify, evaluate, and communicate scientific insights, research opportunities, and unmet medical needs from the field to internal stakeholders.
・Support the scientific evaluation of Investigator‑Initiated Trial (IIT) concepts, including providing input on scientific feasibility and alignment with medical strategy, while final approval decisions remain with designated internal governance bodies.
・Represent Medical Affairs in scientific forums, congresses, and advisory interactions as a subject‑matter expert, within approved scope and training.

The MSL does not have authority to:
・Engage in promotional selling activities or commercial decision‑making.
・Approve financial commitments, contracts, or study funding.
・Make commitments regarding product supply, pricing, or regulatory outcomes.

■業務内容
・GxP規制への対応業務（新たな薬事規制への対応に係る業務を含む）
・当局提出資料（CTD、承認申請書、試験報告書等）の作成、当局窓口
・新規プロジェクトにおいて薬事戦略の立案と推進（社内外調整業務を含む）

■同社にて下記の業務に従事して頂きます。

【具体的には】
品質部門の責任者候補
・製品の仕様における書類の届出・認証・承認業務
・品質不具合分析・解析など
・品質管理・保証体制の確立・強化
・製造現場への指導
・顧客への品質対応
・部門マネジメント

■薬事業務・管理者業務をお任せします。
※体外診断用医薬品は約70種類。医療機関の検査室や人間ドックなどで使われる汎用自動分析装置用の試薬「N-アッセイ」シリーズに加え、骨粗鬆症の診断に用いる「TRACP-5b」や、再発乳がんの診断に用いる「CSLEX」など国内外から高い評価を得ています。
＜具体的業務＞
・体外診断薬の薬事承認申請　
・薬事承認に関するPMDA対応及び折衝
・関係官庁対応及び折衝　
・関係法令の遵守監督
・製造所管理

HSSE（Health, Safety, Security, Environment）に関する業務をご担当いただきます。