长沙招聘

Summary:

The Medical Writer will be expected for knowing, understanding, and ensuring adherence to regulatory guidelines and department document standards. He/she will also be expected to write, review and ensure maintenance of document standardization through use of model documents/templates and appropriate peer review.

Responsibilities:

• Working with the clinical team, the Medical Writer will be responsible for writing Clinical Study Protocols, Clinical Study Protocol Amendments, Clinical Study Reports, and Patient Safety Narratives. Opportunities to write and contribute to Regulatory documents such as Clinical Summaries and Briefing Documents.
• Reviewing documents related to the CSR, such as the Statistical Analysis Plan and draft tables, figures and listings, and ensuring that they provide the appropriate information/data for a CSR.
• Provide appropriate input on others' documents, including review of key contributing documents, such as the SAP.
• Represent medical Writing at cross-company and TA meetings.
• Follow a discussion to its conclusion, synthesize the message, and present clear accurate prose quickly.
• Manage processes and organize priorities.
• Solve problems; Foster collaboration to resolve conflict.
• Performs other tasks as directed by the line manager.

Requirements:

• Education of advanced degree in life science preferred.
• Experience of minimum of 5+ years of industry experience to include a minimum of 3+ years of Medical Writing experience.
• Demonstrated writing skills with strong command of bilingual (English and Chinese) language and grammar.
• Have written CSPs, IBs, DSUR, ISEs and ISSs, Clinical Overviews and Summaries. Experience authoring RMP, Requests for PIP/PSP and PIP/PSP Waiver, clinical bioanalytical reports a plus.
• Have the ability to work independently with team spirit.
• Have a good working knowledge of PDF, and Project. Skilled in use of MS WORD. Have used 1 or more EDM systems.

百奥泰生物制药股份有限公司（股票代码：688177）秉承“创新只为生命”的理念，致力于开发新一代创新药和生物类似药，用于治疗肿瘤、自身免疫性疾病、心血管疾病以及其它危及人类生命或健康的重大疾病。公司已推动五款候选药物进入后期临床试验，其中格乐立（阿达木单抗）已在中国获批用于治疗类风湿关节炎、强直性脊柱炎、银屑病、克罗恩病和葡萄膜炎。此外，公司另有多款主攻肿瘤和自身免疫性疾病的候选药物处于不同的临床开发阶段。公司始终以患者的福祉作为首要核心价值，通过创新研发为患者提供安全、有效、可负担的优质药物，以满足亟待解决的治疗需求。欲了解更多信息，请访问公司官网或关注我们的微信公众号“百奥泰”。
Bio-Thera？Solutions, Ltd.a leading commercial-stage biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next-generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials, one of which, QLETLI, a biosimilar to？Humira？(adalimumab), is available to patients with rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis,？Crohn's disease or uveitis in China. In addition, the company has multiple candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases.