北京招聘

Job Responsibilities

• Act as a medical writer on internal clinical studies at a moderate to complex level. Some examples of medical documents include Investigator's Brochure, Clinical Trial Protocol, ICF, CSR, etc.
• Produce high quality and on-time writing deliverables ensuring scientific consistency between related documents or studies in a clinical program.
• Proof reading clinical trial related documents. Examples like CRF, Source document, Medical monitoring plan, etc.
• Monitor ongoing clinical studies from drug safety and deviation control perspective.
• Manage KOLs relationship and maintain ongoing scientific exchange.
• Participates in regulatory communication/submission.
• Provides scientific and medical writing consultancy to internal colleagues (RA/QA/Research).
• Develops and implements training for future medical writers joining the team.
• Conducts protocol training for clinical operation colleagues.
• Participates in project management meetings and vendor communication.
• Perform other duties as assigned (such as literature retrieval, short-term business trip, etc.)

    

Job Qualifications    

• Life science related degree (BA, MS, MD, PhD).
• Good English writing and communication (preferred) capacity.
• A minimum of 2 years medical writing experience in a pharma, biotech, or CRO setting.
• Good knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
• Must possess all requisite skills of the Medical Writer position, including excellent grammatical, editorial, and proofreading skills, and the ability to interpret and present clinical data.
• Must possess the ability to coordinate production of deliverables and provide medical writing regulatory requirement-related consultancy to a project team.
• Must possess independence in decision making and problem solving.
• PREFERRED – Vaccine related writing experience.
• PREFERRED - Master’s degree in a science or health-related field; Experience with regulatory submissions (CTA/IND) and knowledge of CTD formatting is a plus.

    

General note(s)

l  Remote working is allowed if high level of autonomy is shown. Suzhou-based is still preferred.

    艾棣维欣(苏州)生物制药有限公司位于苏州工业园区，是研发创新疫苗的生物技术公司。公司专注研究基因工程疫苗、DNA疫苗、新型疫苗佐剂技术，在国内外有系统的知识产权布局。
    公司运用这些平台技术，主要进行抗病毒疫苗的研发，尤其在新型病毒性肺炎疫苗研发领域拥有国际先进技术实力。
    艾棣维欣和美国INOVIO制药联合研发的新型冠状病毒DNA疫苗已在中美同步开展临床试验。艾棣维欣开发的新型呼吸道合胞病毒（RSV）肺炎疫苗正在海外开展临床研究，研发进展居于全球前列。
    Advaccine Biopharmaceuticals Suzhou Co., Ltd. is a biotechnology company developing innovative vaccines in BioBay of Suzhou Industrial Park. The company focuses on the research of genetic engineering vaccine, DNA vaccine, innovative vaccine adjuvant technology. There is a systematic distribution of intellectual property in china and abroad.
    The company uses these technologies, mainly engaged in the research and development of antiviral vaccines, especially the company’s innovated vaccine for viral pneumonia possesses the leading technology worldwide.
    Clinical trials are being conducted for the COVID-19 DNA vaccine, co-developed by Advaccine and INOVIO Pharmaceuticals simultaneously in China and the United States. The company’s innovative vaccine for respiratory syncytial virus (RSV) is under clinical investigation abroad and its progress of research and development is in the forefront of the world.