天津招聘

Position Summary:
The Medical Writer collaborates with members of cross-functional teams to prepare the high-quality clinical-related written documents ensuring the coordination and integration of the scientific, medical and regulatory input from different therapeutic areas within preferred timelines.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following:
？Develops well-structured and concise clinical documents (e.g., synopses, protocols, amendments, IND submissions, clinical study reports, high levels summary for briefing documents and dossier), and certain non-clinical documents (e.g., initial investigator’s brochure) for timely submission to health authorities worldwide according to good documentation practice
？Participates in clinical development planning
？Manages formal requirements of document product and review cycles including formats and procedures in accordance with good clinical practice (GCP), International Conference on Harmonization (ICH), other relevant regulatory guidelines, and company SOPs
？May perform QC review of clinical/medical-related documents or part of documents prepared by other departments that accurately reflect the data/results, and recommends quality process improvements when needed
？Facilitates appropriate internal and external reviews of assigned documents and take responsibility for on-time delivery
？Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
？Maintains high standards of scientific output and effective process management but may propose revisions to SOPs or suggest process improvements
？Manages, reviews and monitor resource requirements to support effective delivery of written deliverables within budget

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the experience, knowledge, skill, and/or ability required for ideal candidates.

Education/Experience:
？PhD in relevant life science or medicine-/medical science-related field or a Master’s degree/Bachelor Degree in educational equivalent with a minimum of 3 years (MS) to 5 years (BS) of experience in medical writing experience of one or more of the oncology therapeutic areas including vendor management in the pharmaceutical/biotech industry
？Broad experience writing and managing the production of clinical documents associated with multiple studies at various stages
？Understanding of documentation requirements related to regulatory filings (e.g., monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions) and scientific writing components (e.g., dossier, briefing documents, etc.)
？Experience in interacting with cross-functional study team members; ability to facilitate discussions and decision-making with cross-functional team members
Knowledge, Skill and Abilities:
？Good knowledge of drug development process (preferably clinical development) and good understanding of common statistical methods used in clinical trials
？Ability to integrate, interpret and summarize complex data from a variety of sources in a clear and concise manner and to present a line of argument and explanation as required in regulatory documents and publications
？Proven scientific writing skills and ability to communicate fluently and effectively in English and Chinese, both in writing and verbally
？Proven experience in the use of key literature databases (e.g., PubMed, Cochrane) and the conduct of literature reviews
？Strong knowledge of Microsoft Office applications including Word, PowerPoint, and Excel, bibliographic software such as EndNote
？Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to detail and accuracy
？Ability to communicate with team members for setting timelines expectations; monitor and communicate progress against milestones; escalate complex issues appropriately
？Excellent interpersonal, active listener and influencing skills; establishes and maintains professional and productive working relationship with team members
？Ability to identify the deficiencies, errors, and inconsistencies in deliverables using flexibility and persistence as appropriate
Working Environment: This is a high growth, fast paced organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be less than 10% of work time.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
？Extensive use of telephone and face-to-face communication requiring accurate perception of speech
？Extensive use of keyboard requiring repetitive motion of fingers
？Regular sitting for extended periods of time

    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。