苏州招聘

Responsibilities:

? Author, co-author, critically edit, and format regulatory documents including NDAs, MAAs, INDs, protocols, CSRs, Investigator Brochures, annual reports, briefing documents, and other regulatory submissions;

? Author, co-author, and critically edit publications including abstracts, posters, slide presentations, manu"script"s, and review articles;

? Manage medical writing contracted with independent consultants, CROs, and other communication vendors;

? Manage overall medical writing timelines and resources across project teams (including internal and external resources);

? Serve as the functional area lead on project teams and advise such teams on content, format, and style-guide requirements for documents;

? Lead the development of medical writing processes, SOPs, work instructions, and document quality control;

? Participate in the development of publication plans;

? Manage the hiring, supervising, mentoring, and development of internal medical writing staff as the function expands;

? Maintain subject area expertise related to the company’s investigational products, disease indications, and regulatory and publication guidelines;

? Develop a budget for the medical writing department;

? Willingness to perform miscellaneous job-related duties and additional duties and responsibilities as assigned.

Requirements:

? Advanced degree in life sciences required (MS, PhD, Pharm D, or equivalent);

? 5 years or more of medical writing experience in the pharmaceutical or biotechnology industry;

? Demonstrated success managing medical writers (in-house and contract);

? Previous leadership role in major regulatory filings (NDA, BLA, MAA);

? Excellent ability to interpret and present scientific and clinical trial data and understand statistical analyses;

? Excellent writing skills coupled with comprehensive knowledge of the drug development process and regulatory guidelines;

? Effective collaborator possessing the ability to foster strong working relationships and build consensus within multidisciplinary teams;

? Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal supervision;

? Excellent interpersonal and communication skills;

? Advanced knowledge of clinical and regulatory documents and publication practices including CFDA, GCP, and ICH;

? Expert user of Microsoft Word, PowerPoint, and Excel.

信达生物成立于2011年，致力于开发、生产和销售用于治疗肿瘤等重大疾病的创新药物。2018年10月31日，信达生物制药在香港联交所主板挂牌上市，股票代码：01801。

自成立以来，公司凭借创新成果和国际化的运营模式在众多生物制药公司中脱颖而出。建立起了一条包括32个新药品种的产品链，覆盖肿瘤、代谢疾病、自身免疫等多个疾病领域，7个产品（信迪利单抗注射液，商品名：达伯舒，英文商标：TYVYT；贝伐珠单抗生物类似药，商品名：达攸同，英文商标：BYVASDA；阿达木单抗生物类似药，商品名：苏立信，英文商标：SULINNO；利妥昔单抗生物类似药，商品名：达伯华，英文商标：HALPRYZA；pemigatinib口服抑制剂，商品名：達伯坦，英文商标：PEMAZYRE；奥雷巴替尼片，商品名：耐立克；雷莫西尤单抗，商品名：希冉择，英文商标：CYRAMZA）获得批准上市， 1个品种在NMPA审评中，另外还有19个产品已进入临床研究。

信达生物已组建了一支具有国际先进水平的高端生物药开发、产业化人才团队，包括众多海归专家，并与美国礼来制药、Adimab、Incyte、MD Anderson 癌症中心和韩国Hanmi等国际合作方达成战略合作。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。

“始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的理想和目标。