上海招聘

• To work with internal and external customers including investigator, clinician, pharmacologist, analyst ,statistician and any involved functions to develop concept sheet, synopsis for submission to regulatory health authority
• To prepare medical document package including investigator’s brochure, protocol, ICF, patient dairy, etc; for regulatory submission and ethical committee submission together with internal and external partners
• Work with internal and external customers to prepare clinical study result, summary of clinical efficacy and safety, and efficacy and safety updates
• To act as documentation consultant in clinical study teams to ensure compliance of documentation to GCP, SOPs, and external guidelines
• To assure preparation, review, QC, approval and archival of clinical documents.
• To give professional input to publications prepared by doctors/investigators
• Providing medical study literature review and guideline update in a timely manner;
• Obtaining insight on new messages and medical value based on RWD and Mata analysis.

Qualification

• Master Degree of medical related major, clinical laboratory or biochemistry education background.
• Medical Writing, data interpretation and communication;
• Strong Communication skill, internal/external customers Orientation & Relationship Management.
• Have at least 4 years of diverse healthcare experience in medical writing or clinical research in pharmaceutical, medical device or IVD companies. Experience of eCTD document preparation and/or journal publication is preferred.

科济生物简介

科济生物医药（上海）有限公司（以下简称“科济生物”）是聚焦于CAR-T细胞、抗体等肿瘤免疫治疗药物的创新型生物医药企业。

科济生物成立于2014年，总部位于上海，在中国和美国设有实体运营中心。目前公司已建立了广泛的CAR-T候选产品研发管线，开发了能够覆盖大部分实体瘤及血液肿瘤的高效特异性CAR-T及抗体药物候选产品，以满足日益增长的医疗需求。公司已率先启动了多项治疗复发/难治性实体瘤的CAR-T临床研究项目，包括针对肝细胞癌（HCC）和肺鳞癌的CAR-GPC3-T项目，CAR-EGFR / EGFRvIII-T试验用于胶质母细胞瘤，CAR-Claudin18.2-T用于胃癌和***癌等的临床研究。目前科济生物已经获得多项国内外的CAR-T细胞新药临床试验许可，其中BCMA CAR T细胞药物还分别获得美国和欧盟药监局的"再生医学先进疗法（RMAT）"和"优先药物（PRIME）"资格。

此外，科济生物还拥有治疗性抗体药物的研发平台，其领先的针对Claudin18.2的人源化单克隆抗体已获得国家药监局（NMPA）的IND批准。

  展望未来，科济生物将秉承“科创济世”的价值观，积极与国内外顶尖研究机构、知名医院合作，推进各种先进治疗手段的研制，从而造福更多肿瘤患者。