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Director, Managed Access Regulatory Strategy

US · Durham · Remote · Full-time · Lead

Remote worldwideLead / managementOpen to China
Regulatory StrategyManaged AccessExpanded Access ProgramsPost-Trial AccessOpen Label ExtensionCompassionate UseNamed Patient ProgramsGlobal Regulatory RequirementsProduct LabelingImport/Export ComplianceClient ConsultingBusiness DevelopmentProposal DevelopmentCross-Team Collaboration

Salary not stated

AI summary

About the company

IQVIA 是全球领先的生命科学与医疗健康领域临床研究服务、商业洞察及医疗智能提供商，助力创新医疗的研发与商业化，改善患者结局与人群健康。

Role overview

IQVIA 招聘全职远程的受管理式医疗准入监管策略总监，负责为传统临床试验外的研究性疗法构建监管策略，支持患者准入项目，对接制药与生物科技赞助商，将客户需求转化为方案并推动业务发展。

Responsibilities

  • 支持各类研究性疗法的受管理式医疗准入监管策略
  • 为赞助商提供全球准入路径的监管建议
  • 指导各国监管要求、产品标签及进出口合规
  • 作为监管专家参与客户讨论、提案及投标防御
  • 跨团队合作识别、塑造并销售新客户机会
  • 优化 IQVIA 受管理式医疗准入监管服务
  • 构建相关监管方法、模板及定价方案
  • 推动监管策略与市场需求及交付对齐

Requirements

  • 10年以上监管事务、策略或制药服务相关经验
  • 有各类研究性疗法准入项目的支持经验
  • 熟悉研究性疗法准入的全球监管要求
  • 具备产品标签、各国监管及进出口合规经验
  • 拥有客户对接、方案塑造及提案沟通能力
  • 需具备生命科学相关本科及以上学历

Nice to have

  • 具备客户咨询、业务开发及销售相关经验
  • 跨多职能团队协作的经验
  • 曾任职于受管理式机构、CRO或药企
  • 拥有MS、MPH、PharmD等高级学位
  • 在增长型环境中开展工作的经验

Pay & benefits

  • 年薪范围140,200-390,600美元
  • 提供激励计划、奖金及健康福利
  • 完整的健康与福利保障
  • 相关学习与职业发展支持

Hiring process & how to apply

  • 通过Lifelancer平台申请岗位
  • 提交相关资质证明材料
  • 招聘流程包含多轮专业面试
  • 需确保申请信息真实完整

Notes for China-based candidates

  • 岗位为全职远程，面向全球候选人
  • 结算及薪资以美元为准
  • 需具备较强的英文沟通能力
  • 无强制境外居住要求

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Excerpt

Job Title: Director, Managed Access Regulatory Strategy Job Location: Durham, North Carolina, United States of America Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Overview IQVIA is seeking a Director, Managed Access Regulatory Strategy to help build a regulatory…

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Director, Managed Access Regulatory Strategy · Lifelancer · Global Search | Fintegrity