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Senior Medical Writer

面议

市辖区硕士及以上4年及以上

发布时间:2023-09-06

职位描述

PRIMARY FUNCTION
__________________
? Writing different types of documentation for clinical development such as study protocol, IB, CSR, publications, etc.

MAJOR RESPONSIBILITIES AND DUTIES
___________________________________
? Coordinate and lead the composition and production of a wide range of different types of documentation concerned with health care and medical topics. The work of a medical writer involves strong skills in such areas not only as writing but also analytical and research skills; as well as some knowledge in the medical field and regulatory policies / requirements for documents used in regulatory submissions.
? Develop and implement training for medical writers in areas of expertise
? Serve as an mentor to junior staff members
? Perform other tasks as directed by the line manager

Qualifications
____________
? Have strong writing skills and a firm understanding of medical terms. He/She might use diagrams, anatomical images, photographs and charts to explain medical content, so proficiency with word processing software is a must. Researching is a required job skill, hence familiarity with reputable medical journals, regulatory requirements, and clinical research publications is a plus.
? Be familiar with authority regulations and follow all steps in the submission and approval process.
? Shall have a minimum of a bachelor's degree in health science. Advanced degree, such as MSc, M.D, Pharm.D. or Ph.D. in health care or a scientific field is a plus.
? Medical writer experience in pharmaceutical / biotech company or CRO
? Be proficiency with word processing and other office software
? Experience in clinical study and relevant documents writing
? Good communication skills required

Internal-External Relations
_____________________

? Internal: HUTCHMED study team, regulatory team
? External: CRO, Pharmaceutical comp**************************

其他要求

  • 1人
  • 文字编辑/组稿

公司介绍

和黄中国医药科技有限公司(简称“ 和黄医药 ”或“ Chi-Med ”)(纳斯达克 / 伦交所:HCM)是一家创新型生物医药公司,在过去20年间致力于发现和全球开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。目前,和黄医药共有8个抗癌类候选药物正在全球开发中,并在中国本土市场拥有广泛的商业网络。

和黄医药成立于2002年,为在纽约和伦敦两地上市的和黄中国医药科技有限公司(纳斯达克/伦交所: HCM)旗下专注于新药研发业务的子公司, 研发中心坐落在上海浦东张江高科技园区,海外临床开发及注册中心位于美国新泽西,具有完备的研发平台和GMP生产基地。管理团队成员均有在知名跨国医药和生物医药企业工作的经历,参与了多个全球新药研发;公司目前有500余位来自海内外,拥有丰富新药研发经验的科研人员,8大临床在研药物、 30多项临床试验在全球开展。

和黄医药是一家致力于创新药物研发的生物医药公司,专注于发现和开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。 自主研发的抗肿瘤新药呋喹替尼已于2018年9月获国家药品***理局批准上市,并于2019年11月获纳入国家医保药品目录。公司的其他候选药物,如索凡替尼、沃利替尼等,也已进入后期开发,有望在2020及2021年上市。

和记黄埔医药(上海)有限公司

行业:
制药.生物
规模:
1-49人
性质:
其他
地址:
上海市浦东新区张江高科技园区蔡伦路720弄4号楼(邮编:201203)

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