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| 部署・役職名 | Medical Director |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
• Provides medical oversight of assigned clinical studies in the duty as a medical monitor. Often serves as primary medical contact for customers for assigned clinical studies. • Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department. • Responsible for protocol design and development, upon request. Provides input into protocol amendments. • Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed. • Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts. This activity includes, but is not limited to, review of Informed Consent Templates and Subject-Facing Materials, and input into site feasibility evaluations. • Provides medical input into data collection tools, monitoring plans, and review and analysis plans. • Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data. Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data. • Provides after-hours medical coverage for clinical studies. • Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans. • Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines. • May support responses to Requests for Proposals (RFPs) or Bid Defense Meetings (BDMs), upon request. • May provide input to clinical development or regulatory teams within the Company, upon request. • May represent the Company at scientific meetings, upon request. |
| 応募資格 |
【必須(MUST)】 Doctorate degree in medicine and clinical experience in the practice of medicine in the specific therapeutic area. Clinical research experience required.【歓迎(WANT)】 Prefers to have in depth clinical knowledge and worldwide drug development regulations.A strong understanding of the use of medical terminology and of drug names in multiple nations and environments is required. Experience working in matrix teams is preferred. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Effective organizational and interpersonal skills, communication and language skills, and group presentation skills. Above average attention to detail, accuracy, organizational, interpersonal, and team-oriented skills. Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. Ability to be customer-focused and have a disciplined approach to work is critical. Fluency in written and spoken English is essential. Up to 25% travel may be required. |
| アピールポイント | 自社サービス・製品あり 外資系企業 女性管理職実績あり 上場企業 従業員数1000人以上 2年連続売り上げ10%以上UP 年間休日120日以上 産休・育休取得実績あり 教育・研修制度充実 資格支援制度充実 社内公用語が英語 シェアトップクラス マネジメント業務なし 管理職・マネージャー 完全土日休み フレックスタイム 月平均残業時間20時間以内 |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2025/12/10 |
| 求人番号 | 6306244 |
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転職・求人情報の詳細をご覧になる場合は会員登録(無料)が必要です