天津招聘

Position Summary:
Develop trial document according to submission schedule including IB, Protocol and regulatory consultation for IND; Develop medical communication and publication strategy to conduct domestic and international submission for congress and journal; Develop medical strategy on molecules, conduct therapeutic area updates; Maintaining high levels of professional integrity and performance standards by consistently scientifically balanced, clear, concise yet comprehensive medical information to external and internal audience and stakeholder.

Job Descriptions:
1-Team Management
-Team Building and Management
Including: recruitment, talent selection,personnel appointment, performance management, etc .;
-Team Development
Provide team members relevant training, and regulations or learning resources as well.

2-Document preparation
-Develop the medical strategy on new molecules in the phase of pre-IND;
-Support the trial design for molecules or combos in the phase of post-IND;
-Lead Clinical Development Plan for assigned molecules;
-Conduct medical intelligence on trial and therapeutic area updates;
-Lead supportive analyses, e.g. meta-analysis on specific indication.

3-Document review and standard management
-Critically edit and format regulatory documents including NDAs, MAAs, INDs, protocols, CSRs, Investigator Brochures, annual reports, briefing documents, and other regulatory submissions;
-Critically edit publications including abstracts, posters, slide presentations, manuscripts, and review articles;
-Lead the development of medical writing processes, SOPs, work instructions, and document quality control.

4-Others
-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);
-Participate in the development of publication plans;
-Maintain subject area expertise related to the company’s investigational products, disease indications, and regulatory and publication guidelines;
-Develop a budget for the medical Science department.

Job Requirements:
1.PhD degree and above (in pharmaceutical, medical or other relevant biological science)
2.At least 5 years of experience in medical publication or medical or scientific writing.
3.Demonstrated success managing medical writers (in-house and contract). Advanced knowledge of clinical and regulatory documents and publication practices including CFDA, 4.GCP, and ICH. Previous leadership role in major regulatory filings (NDA, BLA, MAA).
5.Proven scientific writing skills and ability to communicate fluently and effectively in English, both in writing and verbally；
6.Strong knowledge of Microsoft Office applications including Word, PowerPoint, and Excel；
7.Excellent ability to interpret and present scientific and clinical trial data and understand statistical analyses;
8.Excellent writing skills coupled with comprehensive knowledge of the drug development process and regulatory guidelines;
9.Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal supervision;
10.Good analytical and problem solving skills
11.Good communication skills
12.Good critical thinking skills
13.Work effectively under pressure
14.Adapt to change as needed
15.Good team management skills

    复宏汉霖（*******）是一家国际化的创新生物制药公司，旨在为全球患者提供质高价优的创新生物药，产品覆盖肿瘤、自身免疫性疾病等领域。自2010年成立以来，公司以全球联动、整合创新为产品开发理念，在中国上海、中国台北和美国加州均设有研发中心，具备了协同增效的突出优势。复宏汉霖主要的产品开发策略是仿创结合，从生物类似药起步，逐步开发创新型单抗产品，结合自主开发的抗PD-1和PD-L1单抗，在国内率先推出免疫联合疗法，前瞻性布局了一个多元化、创新单抗及肿瘤免疫联合疗法管线，打造出研究、开发、商业化生产的综合性生物医药全产业链平台。

    截至目前，复宏汉霖已有1个产品成功上市，2个产品获得中国新药上市申请受理，1个产品获得欧盟营销授权申请受理，10个产品、8个联合治疗方案在全球范围内开展20多项临床试验。其中，公司首款重磅产品汉利康？（利妥昔单抗注射液）于2019年2月获国家药监局新药上市注册批准，成为中国***获批上市的生物类似药。HLX03（阿达木单抗注射液）与HLX02（注射用曲妥珠单抗）已获国家药监局新药上市申请受理，现已纳入优先审评程序。HLX02相继在中国大陆、乌克兰、欧盟波兰和菲律宾全面启动国际多中心3期临床试验，成为国内***开展国际多中心3期临床研究的生物类似药，并于2019年6月获欧洲药品管理局营销授权申请受理。此外，公司已陆续就HLX10（抗PD-1单抗）与自有产品HLX04（贝伐珠单抗生物类似药）、HLX07（抗EGFR单抗）以及化疗联用开展多项肿瘤免疫联合疗法，在全球范围内开展多个临床研究。