16 jobs found for biotechnology pharmaceutical

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    • shanghai, shanghai
    • contract
    • CNY50,000 - CNY80,000 per year
    Job title: HRDCompany Intro:A medical device company that is dedicated to treat pulmonary hypertensionThe Role:You will plan, lead, direct, develop, and coordinate the policies, activities, and staff of the Human Resource (HR) department, ensuring legal compliance and implementation of the organizations mission and talent strategy.What you will do:? Partner with the leadership team and managing key HR processes and topics such as Succession Plan, Performance Management, Annual Salary Review, and Employee Communications, etc.?Set up HR department from 0-1? Act as change agent in dealing with OD topics? Playing as HR Consultant to business manager on people issue handling and ER cases? Other HR Projects to support business needs.What you'll bring? Bachelor's degree or equivalent in a related field? 8 years above working experience in HR area, medical device industry experience? Must have 0-1 experience? Excellent interpersonal, influencing skills to interact with different level of leaders and associates? Strong analytical and problem-solving skills? Excellent written and verbal communication skills in both Chinese and English.? Comfort with ambiguity and ability to use sound judgement to drive complex issues to resolution
    Job title: HRDCompany Intro:A medical device company that is dedicated to treat pulmonary hypertensionThe Role:You will plan, lead, direct, develop, and coordinate the policies, activities, and staff of the Human Resource (HR) department, ensuring legal compliance and implementation of the organizations mission and talent strategy.What you will do:? Partner with the leadership team and managing key HR processes and topics such as Succession Plan, Performance Management, Annual Salary Review, and Employee Communications, etc.?Set up HR department from 0-1? Act as change agent in dealing with OD topics? Playing as HR Consultant to business manager on people issue handling and ER cases? Other HR Projects to support business needs.What you'll bring? Bachelor's degree or equivalent in a related field? 8 years above working experience in HR area, medical device industry experience? Must have 0-1 experience? Excellent interpersonal, influencing skills to interact with different level of leaders and associates? Strong analytical and problem-solving skills? Excellent written and verbal communication skills in both Chinese and English.? Comfort with ambiguity and ability to use sound judgement to drive complex issues to resolution
    • beijing, beijing
    • contract
    • CNY50,000 - CNY80,000 per year
    岗位职责:1.与CMO/CDMO密切合作,进行工艺开发和临床实验药物的制备,获得和管理相关文件、数据和信息,并支持全球各种市场申请的提交和GMP认证;2.领导CMC团队,编写、审核、编辑CMC章节以支持IND,IMPD及CMPA申请的提交;3.执行必要的行动计划以确保项目任务完成。任职要求:1.化学博士学位,有3年以上制药行业原料药工艺开发和生产经验者;2.了解全球ICH法规,曾编写CMC章节以支持全球的IND/CTA申请、许可证申请、年度报告等;3.擅长跨职能团队沟通,包括研发部门、质量部门、生产部门和外部合作者;4.能够协调CDMO进行技术讨论和项目需求合作;5.良好的英语听说读写能力。
    岗位职责:1.与CMO/CDMO密切合作,进行工艺开发和临床实验药物的制备,获得和管理相关文件、数据和信息,并支持全球各种市场申请的提交和GMP认证;2.领导CMC团队,编写、审核、编辑CMC章节以支持IND,IMPD及CMPA申请的提交;3.执行必要的行动计划以确保项目任务完成。任职要求:1.化学博士学位,有3年以上制药行业原料药工艺开发和生产经验者;2.了解全球ICH法规,曾编写CMC章节以支持全球的IND/CTA申请、许可证申请、年度报告等;3.擅长跨职能团队沟通,包括研发部门、质量部门、生产部门和外部合作者;4.能够协调CDMO进行技术讨论和项目需求合作;5.良好的英语听说读写能力。
    • beijing, beijing
    • contract
    • CNY30,000 - CNY50,000 per year
    我的客户是TOP级互联网企业,合伙人及团队成员均毕业于知名院校,工作水平和人员素养优秀。岗位职责:1.深入了解和熟悉医疗行业头部专家业务合作模式,根据公司医疗业务发展战略,制定北上广等核心城市大专家的BD策略,能够有效达成拓展目标;2.支撑线上问诊、权威诊疗案例等业务的发展,建立起头部专家、重要协会对公司的充分认知,协助专家解决所有产品和业务问题,打造专家品牌,提升业务合作体验;3.根据业务发展情况,招募、组建和管理好大专家拓展团队,做好策略制定,持续提升拓展人效。职位要求:1.本科以上,热爱医疗行业,有充足的大专家资源者优先;2.5年以上医疗行业BD团队搭建和管理经验;3.具备清晰的BD策略制定能力,能数据化的管理和指导团队。
    我的客户是TOP级互联网企业,合伙人及团队成员均毕业于知名院校,工作水平和人员素养优秀。岗位职责:1.深入了解和熟悉医疗行业头部专家业务合作模式,根据公司医疗业务发展战略,制定北上广等核心城市大专家的BD策略,能够有效达成拓展目标;2.支撑线上问诊、权威诊疗案例等业务的发展,建立起头部专家、重要协会对公司的充分认知,协助专家解决所有产品和业务问题,打造专家品牌,提升业务合作体验;3.根据业务发展情况,招募、组建和管理好大专家拓展团队,做好策略制定,持续提升拓展人效。职位要求:1.本科以上,热爱医疗行业,有充足的大专家资源者优先;2.5年以上医疗行业BD团队搭建和管理经验;3.具备清晰的BD策略制定能力,能数据化的管理和指导团队。
    • shanghai, shanghai
    • contract
    Responsibilities1. Build a strong multi-discipline translational research team to support drug discovery and development pipeline in oncology and immunology.2. Develop, direct, and drive translational research strategy to support program specific clinical development with a focus of, but not limit to MOA understanding, indication selection and patient population selection/stratification.3. Drive and support clinical trial biomarker data analysis and interpretation, to correlate biological response with clinical outcome, and enable proof of mechanism/ proof of concept evaluation.4. Establish relationships and effectively partner with other key functions including discovery. clinical development and clinical operation to execute translational activities.5. Support scientific input and review of all translational medicine aspects of clinical and regulatory documents, including but not limited to development plans, study protocols. clinical study reports, regulatory submissions and responses to any regulatory questions, etc.6. Identify and lead the evaluation, validation and implementation of novel technologies and capabilities both internally as well as at CROs for translational and biomarker research.7. Provide strategic translational input and guide bioinformatics support to early discovery projects to ensure a clear sight into the clinic.8. Develop resource and budget plan for translational research team, to ensure program progress.9. Lead, mentor and develop a highly effective team of translational and clinical biomarker. scientists, optimize existing processes to ensure best practice.10. Communicate critical translational and biomarker activities, risks, and milestones to key stakeholders including Executive Team, functional heads and program teams.Qualification1. PhD in Life Science areas, with expertise in oncology and immunology preferred.2. PhD with 8+ years of experience in the drug development process (preclinical, translational or clinical) within a pharmaceutical company or biotech industry is preferred.3. Demonstrated knowledge of various biomarker platforms (such as IHC, flow cytometry, NGS, etc.) and their clinical practice is preferred. Strong people management skills, leading by example with a high level of emotional intelligence, and be willing to work collaboratively with other functional groups.4. Ability to work in a fast-paced environment.5. Strong interpersonal and communication skills with strong sense of teamwork.6. Fluent English in writing and oral.
    Responsibilities1. Build a strong multi-discipline translational research team to support drug discovery and development pipeline in oncology and immunology.2. Develop, direct, and drive translational research strategy to support program specific clinical development with a focus of, but not limit to MOA understanding, indication selection and patient population selection/stratification.3. Drive and support clinical trial biomarker data analysis and interpretation, to correlate biological response with clinical outcome, and enable proof of mechanism/ proof of concept evaluation.4. Establish relationships and effectively partner with other key functions including discovery. clinical development and clinical operation to execute translational activities.5. Support scientific input and review of all translational medicine aspects of clinical and regulatory documents, including but not limited to development plans, study protocols. clinical study reports, regulatory submissions and responses to any regulatory questions, etc.6. Identify and lead the evaluation, validation and implementation of novel technologies and capabilities both internally as well as at CROs for translational and biomarker research.7. Provide strategic translational input and guide bioinformatics support to early discovery projects to ensure a clear sight into the clinic.8. Develop resource and budget plan for translational research team, to ensure program progress.9. Lead, mentor and develop a highly effective team of translational and clinical biomarker. scientists, optimize existing processes to ensure best practice.10. Communicate critical translational and biomarker activities, risks, and milestones to key stakeholders including Executive Team, functional heads and program teams.Qualification1. PhD in Life Science areas, with expertise in oncology and immunology preferred.2. PhD with 8+ years of experience in the drug development process (preclinical, translational or clinical) within a pharmaceutical company or biotech industry is preferred.3. Demonstrated knowledge of various biomarker platforms (such as IHC, flow cytometry, NGS, etc.) and their clinical practice is preferred. Strong people management skills, leading by example with a high level of emotional intelligence, and be willing to work collaboratively with other functional groups.4. Ability to work in a fast-paced environment.5. Strong interpersonal and communication skills with strong sense of teamwork.6. Fluent English in writing and oral.
    • null
    • contract
    Our client is a global clinical stage bio-pharmaceutical company dedicated to discovering and developing breakthrough cell therapies to address major industry challenges and fulfill unmet medical needs in the treatment of cancer,which is expanding the team on a global level including the United States. We are a highly driven team which enjoys working on unique opportunities in a new public listed company across continents with exemplary teamwork in our matrix organization.Responsibilities:?To lead Business Development& Licensing (BD&L) efforts across current and new technology platforms in Car T therapeutic area?To skillfully design partnering structures tailored to each individual project ?To provide outstanding transaction skills through the entire deal making process ?To proactively monitor the external business environment and maintain a knowledge base of licensing transactions and other company activities ?To coordinate inter departmental communications and acquire enough support from colleagues for scientific, regulatory, legal, IP, finance, communication, and commercial ?To continuously strengthen industry networking to secure the identification of attractive partnering opportunitiesRequirements:?10+ years industry experience with at least 5+ years in Licensing and Business Development at multinational pharmaceutical companies focus on immuno oncology area?Proven track record of achievement in out licensing deals in immuno oncology area ?Adequate financial modelling and commercial forecast expertise in order to conduct financial analysis on target assets ?Excellent multitasking capability, strong project management skills, and outstanding presentation skills ?Established network of contacts in biotech/pharma companies, VC community, and/or key academic institutions ?Candidate with proven strong people skills to lead cross functional teams, will be preferred.?Candidates with extra experiences in Corporate Development, Strategy, Competitive Intelligence, and/or Investor Relations, will be preferred.
    Our client is a global clinical stage bio-pharmaceutical company dedicated to discovering and developing breakthrough cell therapies to address major industry challenges and fulfill unmet medical needs in the treatment of cancer,which is expanding the team on a global level including the United States. We are a highly driven team which enjoys working on unique opportunities in a new public listed company across continents with exemplary teamwork in our matrix organization.Responsibilities:?To lead Business Development& Licensing (BD&L) efforts across current and new technology platforms in Car T therapeutic area?To skillfully design partnering structures tailored to each individual project ?To provide outstanding transaction skills through the entire deal making process ?To proactively monitor the external business environment and maintain a knowledge base of licensing transactions and other company activities ?To coordinate inter departmental communications and acquire enough support from colleagues for scientific, regulatory, legal, IP, finance, communication, and commercial ?To continuously strengthen industry networking to secure the identification of attractive partnering opportunitiesRequirements:?10+ years industry experience with at least 5+ years in Licensing and Business Development at multinational pharmaceutical companies focus on immuno oncology area?Proven track record of achievement in out licensing deals in immuno oncology area ?Adequate financial modelling and commercial forecast expertise in order to conduct financial analysis on target assets ?Excellent multitasking capability, strong project management skills, and outstanding presentation skills ?Established network of contacts in biotech/pharma companies, VC community, and/or key academic institutions ?Candidate with proven strong people skills to lead cross functional teams, will be preferred.?Candidates with extra experiences in Corporate Development, Strategy, Competitive Intelligence, and/or Investor Relations, will be preferred.
    • shanghai, shanghai
    • contract
    Head of biology (Sr. Director/VP level; Based in Shanghai)solid management skills; capable of engaging in detailed scientific experimental designs; and excellent scientific interpreter.Responsibilities- 1.Establish, lead and direct in vitro assay group and in vivo pharmacology group function.2.This individual will provide scientific leadership and play a pivotal role from project initiation to late-stage research. 3.The role will involve the design, management, and interpretation of biological studies using internal resources and CROs. Requirements1.12+ years in the biotech/pharmaceutical industry or in academic institutes having associate professor rank or above with PhD or equivalent in biology with high quality publications.2.An immunology background is required, ideally with high degree of familiarity with in vitro immunology assays and in vivo IO animal model, preferably with working or research experience in Immuno-Oncology field before.3.Strong interest in exploring novel biology and MOA.4.Excellent project management skill.5.Strong communication skills in both Chinese and English and excellent organizational skills.
    Head of biology (Sr. Director/VP level; Based in Shanghai)solid management skills; capable of engaging in detailed scientific experimental designs; and excellent scientific interpreter.Responsibilities- 1.Establish, lead and direct in vitro assay group and in vivo pharmacology group function.2.This individual will provide scientific leadership and play a pivotal role from project initiation to late-stage research. 3.The role will involve the design, management, and interpretation of biological studies using internal resources and CROs. Requirements1.12+ years in the biotech/pharmaceutical industry or in academic institutes having associate professor rank or above with PhD or equivalent in biology with high quality publications.2.An immunology background is required, ideally with high degree of familiarity with in vitro immunology assays and in vivo IO animal model, preferably with working or research experience in Immuno-Oncology field before.3.Strong interest in exploring novel biology and MOA.4.Excellent project management skill.5.Strong communication skills in both Chinese and English and excellent organizational skills.
    • shanghai, shanghai
    • contract
    Our client is a clinical stage biopharmaceutical company focusing on cancer immunotherapy. Grow and mature a newly established line function responsible for all aspects of translational sciences for a pipeline of over ten pre-clinical programs and three early-stage clinical programs. The team is accountable for biomarker strategy of projects and translational exploratory work to strengthen understanding of target biology.We are seeking a highly experienced, performance driven and motivated translational expert with strong track record in biotechnology or pharma companies to join. The successful candidate will be accountable for leading all aspects of our recently established TRM team and managing translational scientists.Qualifications1)MD/Ph.D., Ph.D. / Master degree in biochemistry, cell biology, pharmacology or other related field; candidates with immunology and/or oncology background are strongly preferred. 2)At least seven years of relevant industry working history or at least three years of proven project leadership or management experience and track record of milestone accomplishments in an industry setting or academic lab with industry collaborations.3)Well trained professional in big multinational companies and international experience is desired.4)Significant hands-on experience with assay development or execution in either cell biology or pharmacology to allow trouble-shooting and further strengthening of our research platform; experience with immuno-oncology in vitro, ex vivo or in vivo assays is a plus.5)Extraordinary flexibility and ability to think independently but work collaboratively within a big multidisciplinary matrix team of a fast-growing biotechnology organization.6)Empowering leadership with ability to support, coach and develop team.7)Demonstrate Elpiscience culture of courage, ownership and rigor.8)Excellent written and verbal communication skills in both English and Chinese are required.
    Our client is a clinical stage biopharmaceutical company focusing on cancer immunotherapy. Grow and mature a newly established line function responsible for all aspects of translational sciences for a pipeline of over ten pre-clinical programs and three early-stage clinical programs. The team is accountable for biomarker strategy of projects and translational exploratory work to strengthen understanding of target biology.We are seeking a highly experienced, performance driven and motivated translational expert with strong track record in biotechnology or pharma companies to join. The successful candidate will be accountable for leading all aspects of our recently established TRM team and managing translational scientists.Qualifications1)MD/Ph.D., Ph.D. / Master degree in biochemistry, cell biology, pharmacology or other related field; candidates with immunology and/or oncology background are strongly preferred. 2)At least seven years of relevant industry working history or at least three years of proven project leadership or management experience and track record of milestone accomplishments in an industry setting or academic lab with industry collaborations.3)Well trained professional in big multinational companies and international experience is desired.4)Significant hands-on experience with assay development or execution in either cell biology or pharmacology to allow trouble-shooting and further strengthening of our research platform; experience with immuno-oncology in vitro, ex vivo or in vivo assays is a plus.5)Extraordinary flexibility and ability to think independently but work collaboratively within a big multidisciplinary matrix team of a fast-growing biotechnology organization.6)Empowering leadership with ability to support, coach and develop team.7)Demonstrate Elpiscience culture of courage, ownership and rigor.8)Excellent written and verbal communication skills in both English and Chinese are required.
    • shanghai, shanghai
    • contract
    Key responsibilities:Alliance Management (60%)?Work with alliance partners (US/Germany/UK/France/Korea/China) to manage the execution of BD agreements of company’s pipeline from R&D to commercial stage (20%)?Manage the governance of partnerships at joint steering committee (JSC) level and coordinate all JSC level communications (10%)?Issue management - issues that require immediate senior leadership attention while diligently manage issues and minimize crisis management situations (10%)?Establish the alliance management process and SOP (20%)Portfolio Strategy and Analytics (40%)?Work on due diligence, forecast and financial analysis to structure the deal and facilitate the senior management decision (20%)?Partner with multiple functions to develop market assessment, feasibility assessment and commercial strategy for BD opportunities (20%)To be successful in this role, you should possess the following credentials:?Bachelor or Advanced degree in a biomedical field or equivalent, preferably with experience in rare diseases; PhD or MBA is strongly preferred?5~7 years of related experience in business development, alliance management, strategy, portfolio management, or marketing?Strong communication skills to manage internal and external stakeholders across different cultures?Outstanding analytical skills with strong business acumen?Ability to work independently while managing timelines and priorities?Strong leadership ability to lead and manage a team as the company grows
    Key responsibilities:Alliance Management (60%)?Work with alliance partners (US/Germany/UK/France/Korea/China) to manage the execution of BD agreements of company’s pipeline from R&D to commercial stage (20%)?Manage the governance of partnerships at joint steering committee (JSC) level and coordinate all JSC level communications (10%)?Issue management - issues that require immediate senior leadership attention while diligently manage issues and minimize crisis management situations (10%)?Establish the alliance management process and SOP (20%)Portfolio Strategy and Analytics (40%)?Work on due diligence, forecast and financial analysis to structure the deal and facilitate the senior management decision (20%)?Partner with multiple functions to develop market assessment, feasibility assessment and commercial strategy for BD opportunities (20%)To be successful in this role, you should possess the following credentials:?Bachelor or Advanced degree in a biomedical field or equivalent, preferably with experience in rare diseases; PhD or MBA is strongly preferred?5~7 years of related experience in business development, alliance management, strategy, portfolio management, or marketing?Strong communication skills to manage internal and external stakeholders across different cultures?Outstanding analytical skills with strong business acumen?Ability to work independently while managing timelines and priorities?Strong leadership ability to lead and manage a team as the company grows
    • null
    • contract
    • CNY30,000 - CNY50,000 per year
    1.参与、领导对新型肿瘤免疫疗法的开发和评估;尤其是在巨噬细胞/树突状细胞/T细胞激活 (activation)和共刺激 (co-stimulation);2.设计,领导,分析和展示免疫实验数据,证明概念和阐释机理;3.执行多种细胞体外功能学实验,流式细胞仪分析等,鉴定肿瘤免疫反应中的新靶点,新药物分子和信号通路; 任职资格1.博士学位,学术界或工业界免疫学或肿瘤学工作经验优先; 2.对免疫学原理有充分的了解和较强的天然免疫背景,尤其是与肿瘤相关巨噬细胞和树突状细胞,熟悉双特异性抗体获共靶向疗法等;3.扎实的免疫学实验技能,包括流式细胞仪(8种以上颜色),细胞系培养和原代细胞纯化,体外功能学实验以及体内疾病模型。具有抗体依赖性细胞吞噬(ADCP)和抗体依赖性细胞毒性( ADCC )经验者优先;原代细胞CRISPR经验者优先;4.出色的沟通和人际交往能力,能够在部门内和部门间会议上展示研究成果;
    1.参与、领导对新型肿瘤免疫疗法的开发和评估;尤其是在巨噬细胞/树突状细胞/T细胞激活 (activation)和共刺激 (co-stimulation);2.设计,领导,分析和展示免疫实验数据,证明概念和阐释机理;3.执行多种细胞体外功能学实验,流式细胞仪分析等,鉴定肿瘤免疫反应中的新靶点,新药物分子和信号通路; 任职资格1.博士学位,学术界或工业界免疫学或肿瘤学工作经验优先; 2.对免疫学原理有充分的了解和较强的天然免疫背景,尤其是与肿瘤相关巨噬细胞和树突状细胞,熟悉双特异性抗体获共靶向疗法等;3.扎实的免疫学实验技能,包括流式细胞仪(8种以上颜色),细胞系培养和原代细胞纯化,体外功能学实验以及体内疾病模型。具有抗体依赖性细胞吞噬(ADCP)和抗体依赖性细胞毒性( ADCC )经验者优先;原代细胞CRISPR经验者优先;4.出色的沟通和人际交往能力,能够在部门内和部门间会议上展示研究成果;
    • null
    • contract
    • CNY50,000 - CNY80,000 per year
    Responsibilities1.Lead in analytical method development, qualification, validation, and tech-transfer of drug substances and drug products, especially for biomolecules and microbiology quality control2.Support the establishments of quality standards and specifications for drug substance and drug product.3.Support CMC dossiers preparation for IND and NDA submissions in compliance with regulations and guidelines4.Support CRO/CMO qualification and management, and review laboratory investigations, OOS/OOT and deviations5.Play a key role in laboratory establishment, and set the compliance standard for activities of the laboratories in compliance with GMP, and ensure overall laboratory readiness for internal audits and regulatory inspections6.Prepare, review and maintain test methods and instrument SOPs, andperform the necessary tests according to the relevant SOPs when needed.Qualification1. B.S. degree in a scientific discipline with at least 8 years of relevant experience, M.S. with at least 6 years of relevant experience. Preferably majored in pharmaceutical sciences, biology, microbiology;2.2. Proven ability in cross-functional cooperation, alignment and ownership in resolving issues3.3.Comprehensive knowledge of biochemical and chemical testing, and experienced in instrument management;4.4.Knowledge in GMP, Quality System, and Pharmacopeias in Pharmaceutical industry5.5.Team player with a “can-do” attitude is huge plus 6.6.Good written and verbal communication skills. Fluency in Chinese and English.
    Responsibilities1.Lead in analytical method development, qualification, validation, and tech-transfer of drug substances and drug products, especially for biomolecules and microbiology quality control2.Support the establishments of quality standards and specifications for drug substance and drug product.3.Support CMC dossiers preparation for IND and NDA submissions in compliance with regulations and guidelines4.Support CRO/CMO qualification and management, and review laboratory investigations, OOS/OOT and deviations5.Play a key role in laboratory establishment, and set the compliance standard for activities of the laboratories in compliance with GMP, and ensure overall laboratory readiness for internal audits and regulatory inspections6.Prepare, review and maintain test methods and instrument SOPs, andperform the necessary tests according to the relevant SOPs when needed.Qualification1. B.S. degree in a scientific discipline with at least 8 years of relevant experience, M.S. with at least 6 years of relevant experience. Preferably majored in pharmaceutical sciences, biology, microbiology;2.2. Proven ability in cross-functional cooperation, alignment and ownership in resolving issues3.3.Comprehensive knowledge of biochemical and chemical testing, and experienced in instrument management;4.4.Knowledge in GMP, Quality System, and Pharmacopeias in Pharmaceutical industry5.5.Team player with a “can-do” attitude is huge plus 6.6.Good written and verbal communication skills. Fluency in Chinese and English.
    • null
    • contract
    • CNY30,000 - CNY50,000 per year
    1.负责公司生物新药注册准备、报批、跟进及协调等相关工作。按照公司目标,制订申报计划,完成所负责产品的国内和/或国际注册(FDA,NMPA等)工作,包括IND/CTA,NDA/BLA等,并负责跟进后续的维护/更新工作;2.负责收集政策法规、技术要求的动态信息,掌握相关产品的注册信息,为公司其它职能或技术部门提供法规支持;3.负责生物新药注册申报资料撰写、编辑和审核;4.进行生物新药注册申报,跟进注册进展,并与相关部门有效沟通;5.负责生物新药申报过程中现场核查的组织协调和准备工作。任职资格:1. 硕士学历至少5年以上药品相关工作经验;本科学历至少8年以上药品相关工作经验,其中至少5年从事药品注册工作;2. 熟悉NMPA、FDA和EMA的注册法规指南;组织或参与过GMP审计;有生物制品相关的工作经验;了解并技术细节,包括SOP、变更控制、偏差调查等;有较好的英语读写听说能力,及较强的文字撰写能力;具备良好的协调和沟通能力,有团队精神;4. 具有优秀的书面表达能力及协调沟通能力、申报资料的撰写和审核的能力;5. 具有优秀的药品注册信息收索和分析调研能力、能提供新药注册方面的建议和方案。
    1.负责公司生物新药注册准备、报批、跟进及协调等相关工作。按照公司目标,制订申报计划,完成所负责产品的国内和/或国际注册(FDA,NMPA等)工作,包括IND/CTA,NDA/BLA等,并负责跟进后续的维护/更新工作;2.负责收集政策法规、技术要求的动态信息,掌握相关产品的注册信息,为公司其它职能或技术部门提供法规支持;3.负责生物新药注册申报资料撰写、编辑和审核;4.进行生物新药注册申报,跟进注册进展,并与相关部门有效沟通;5.负责生物新药申报过程中现场核查的组织协调和准备工作。任职资格:1. 硕士学历至少5年以上药品相关工作经验;本科学历至少8年以上药品相关工作经验,其中至少5年从事药品注册工作;2. 熟悉NMPA、FDA和EMA的注册法规指南;组织或参与过GMP审计;有生物制品相关的工作经验;了解并技术细节,包括SOP、变更控制、偏差调查等;有较好的英语读写听说能力,及较强的文字撰写能力;具备良好的协调和沟通能力,有团队精神;4. 具有优秀的书面表达能力及协调沟通能力、申报资料的撰写和审核的能力;5. 具有优秀的药品注册信息收索和分析调研能力、能提供新药注册方面的建议和方案。
    • shanghai, shanghai
    • contract
    • CNY50,000 - CNY80,000 per year
    This role serves as an expert in the development, validation, transfer and troubleshooting of in vivo functional studies to support company’s biologic therapeutic portfolio, as well as works as a project leader of the internal project to support the project development from the target identification, validation to clinical candidate selection.Responsibilities:1)As project leader, drive and deliver projects independently through project leadership and experimental execution. Supervise and manage the activities of research associates.2)Develop, validate, transfer, and troubleshoot in vivo studies internally and at CROs to support company’s biologic therapeutic portfolio.3)Design and conduct experiments internally and at CROs and interpret results to evaluate and characterize drug-induced immunomodulation of novel therapeutics.4)Identify and propose key therapeutic targets, areas, indications and technology platforms which may synergize with the company’s current pipelines and platforms.5)Be a key scientific leader in participating in the evaluation and assessment of potential in-licensing and out-licensing opportunities or collaborative research projects.Qualifications:1)Ph.D. in Immunology, oncology, cell biology or related field with a minimum of 5 years’ experience in pharmaceutical/biotech industry or in an academic setting. Outstanding candidates with a Master’s degree with a minimum of 8 years’ industry experience will also be considered.2)Ability of science driven thinking of target biology rationale, treatment area medical needs.3)Solid training and background in one of following: immunology, oncology, auto-immunity and/or cell biology.4)Experience with biologics projects, could develop and validate biological assays and cell-based functional assays, and design suitable in vivo study to meet needs of projects, within timeline and quality requirement.5)Proven experience in multiple independently leading projects, candidates and IND enabling.
    This role serves as an expert in the development, validation, transfer and troubleshooting of in vivo functional studies to support company’s biologic therapeutic portfolio, as well as works as a project leader of the internal project to support the project development from the target identification, validation to clinical candidate selection.Responsibilities:1)As project leader, drive and deliver projects independently through project leadership and experimental execution. Supervise and manage the activities of research associates.2)Develop, validate, transfer, and troubleshoot in vivo studies internally and at CROs to support company’s biologic therapeutic portfolio.3)Design and conduct experiments internally and at CROs and interpret results to evaluate and characterize drug-induced immunomodulation of novel therapeutics.4)Identify and propose key therapeutic targets, areas, indications and technology platforms which may synergize with the company’s current pipelines and platforms.5)Be a key scientific leader in participating in the evaluation and assessment of potential in-licensing and out-licensing opportunities or collaborative research projects.Qualifications:1)Ph.D. in Immunology, oncology, cell biology or related field with a minimum of 5 years’ experience in pharmaceutical/biotech industry or in an academic setting. Outstanding candidates with a Master’s degree with a minimum of 8 years’ industry experience will also be considered.2)Ability of science driven thinking of target biology rationale, treatment area medical needs.3)Solid training and background in one of following: immunology, oncology, auto-immunity and/or cell biology.4)Experience with biologics projects, could develop and validate biological assays and cell-based functional assays, and design suitable in vivo study to meet needs of projects, within timeline and quality requirement.5)Proven experience in multiple independently leading projects, candidates and IND enabling.
    • shanghai, shanghai
    • contract
    1) This position will be a member of the core leadership team of early discovery and will take key responsibility in leading R&D projects in target selection and validation, antibody generation and screening, design and execution of in vitro and in vivo functional studies, and development of new technology platforms.2) Leading and supervising a research team to conduct antibody/biologics drug discovery experiment with the goals of discovering, optimizing and delivering new drug candidates for entering CMC and clinical trials.3) Act as a scientific liaison in managing collaborations with different functional groups within the company and external resources.4) Be a key scientific leader in participating in the evaluation and assessment of potential in-licensing and out-licensing opportunities or collaborative research projects.5) Identify and propose key therapeutic targets, areas, indications and technology platforms which may synergize with the company’s current pipelines and platforms.6) Lead all efforts in troubleshooting and solving any technical and scientific issues.7) Contribute to building a positive, team-oriented and results-oriented culture within the team.Requirements:1)Ph.D. and 8+ years of relevant post-doctoral experience in Immunology, oncology, cell biology or related field, including at least 6 years of research experience in a biotech or pharmaceutical company.2)Proven experience in multiple independently leading projects, candidates and IND enabling.3)Proven experience in leading team(s) of peers and in mentoring junior scientists.4)Outstanding written and oral communication skills.Excellent interpersonal skills and ability to work in a fast-paced and dynamic environment.
    1) This position will be a member of the core leadership team of early discovery and will take key responsibility in leading R&D projects in target selection and validation, antibody generation and screening, design and execution of in vitro and in vivo functional studies, and development of new technology platforms.2) Leading and supervising a research team to conduct antibody/biologics drug discovery experiment with the goals of discovering, optimizing and delivering new drug candidates for entering CMC and clinical trials.3) Act as a scientific liaison in managing collaborations with different functional groups within the company and external resources.4) Be a key scientific leader in participating in the evaluation and assessment of potential in-licensing and out-licensing opportunities or collaborative research projects.5) Identify and propose key therapeutic targets, areas, indications and technology platforms which may synergize with the company’s current pipelines and platforms.6) Lead all efforts in troubleshooting and solving any technical and scientific issues.7) Contribute to building a positive, team-oriented and results-oriented culture within the team.Requirements:1)Ph.D. and 8+ years of relevant post-doctoral experience in Immunology, oncology, cell biology or related field, including at least 6 years of research experience in a biotech or pharmaceutical company.2)Proven experience in multiple independently leading projects, candidates and IND enabling.3)Proven experience in leading team(s) of peers and in mentoring junior scientists.4)Outstanding written and oral communication skills.Excellent interpersonal skills and ability to work in a fast-paced and dynamic environment.
    • beijing, beijing
    • contract
    • CNY30,000 - CNY50,000 per year
    我的客户是快速发展的上市创新型抗体药物研发企业,获得国家重大新药创制项目等多项基金支持,具备成熟生产工艺,打造创新抗体药物的研发生产销售全产业链。职位:中央政府事务准入总监职能:1、建立和维护与政府相关部门(卫健委:重点包括疾控中心、医政医管、基层、药政等司局)及相关协会/学会的沟通渠道和良好的互动、合作关系,搭建顺畅的沟通平台,树立及维护公司的专业形象;2、完成项目申报材料的资料收集、材料编写等工作;3、正确解读国家相关政策并及时向公司提供信息及建议;要求:1、本科或以上学历,医学相关专业优先2、5-10年医药行业政府事务工作经验,熟悉中央政府事务部门。3、具备中央准入成功经历。医保、卫生、疾控等领域资源。
    我的客户是快速发展的上市创新型抗体药物研发企业,获得国家重大新药创制项目等多项基金支持,具备成熟生产工艺,打造创新抗体药物的研发生产销售全产业链。职位:中央政府事务准入总监职能:1、建立和维护与政府相关部门(卫健委:重点包括疾控中心、医政医管、基层、药政等司局)及相关协会/学会的沟通渠道和良好的互动、合作关系,搭建顺畅的沟通平台,树立及维护公司的专业形象;2、完成项目申报材料的资料收集、材料编写等工作;3、正确解读国家相关政策并及时向公司提供信息及建议;要求:1、本科或以上学历,医学相关专业优先2、5-10年医药行业政府事务工作经验,熟悉中央政府事务部门。3、具备中央准入成功经历。医保、卫生、疾控等领域资源。
    • shanghai, shanghai
    • contract
    • CNY30,000 - CNY50,000 per year
    ?Primary Purpose of Job (Job Summary) Support business growth and innovation Ensure category strategy in line with business strategy Involve in SRM process KPI setting / performance rating Market insights / intelligence sharing to users Performance review on category lead Drive innovation Critical complaints handling Involve in big projects (i.e. PV selection) Primary contact for global / regional projects Set up project squad team?Principle Roles & Responsibilities / Accountabilities (Major functions of the position) Works closely with stakeholder, providing comprehensive procurement supports to realize business needs and support business objectives in an effective and sustainable way.? Prepare procurement analytics. Share the strategic insights to achieve productivity by deep diving spend data, benchmarking industrial best practice and monitoring user behaviors etc.? Provide consultancy to internal stakeholders with regard to inquiries related to procurement policy, MSA, and suppliers. Deliver training or knowledge sharing to key stakeholders periodically. Conduct regular communication with the key stakeholders of and provide suggestions for best practice and market trends. Work together with category team to develop and manage MSA to reflect business’s needs. Ensure adherence to the Procurement Policy, Directive, Guidelines and local Procurement SOPs. Ensure change management, effective communication and alignment with stakeholders Qualification and Experience ?Education/Qualifications: Bachelor degree, MBA is a plus Leadership Competencies: Growth mindset Strong communication skills and power of influence Supplier and stakeholder managementJob Required Competencies?5-10 year related procurement experience, must have experience in business partnering role? Innovative and willing to do something different Solid negotiation and cost management experience Strong analytical skill Good computer skill (PPT, Excel, Word) Solid presentation skills Fluent English both in written and oral
    ?Primary Purpose of Job (Job Summary) Support business growth and innovation Ensure category strategy in line with business strategy Involve in SRM process KPI setting / performance rating Market insights / intelligence sharing to users Performance review on category lead Drive innovation Critical complaints handling Involve in big projects (i.e. PV selection) Primary contact for global / regional projects Set up project squad team?Principle Roles & Responsibilities / Accountabilities (Major functions of the position) Works closely with stakeholder, providing comprehensive procurement supports to realize business needs and support business objectives in an effective and sustainable way.? Prepare procurement analytics. Share the strategic insights to achieve productivity by deep diving spend data, benchmarking industrial best practice and monitoring user behaviors etc.? Provide consultancy to internal stakeholders with regard to inquiries related to procurement policy, MSA, and suppliers. Deliver training or knowledge sharing to key stakeholders periodically. Conduct regular communication with the key stakeholders of and provide suggestions for best practice and market trends. Work together with category team to develop and manage MSA to reflect business’s needs. Ensure adherence to the Procurement Policy, Directive, Guidelines and local Procurement SOPs. Ensure change management, effective communication and alignment with stakeholders Qualification and Experience ?Education/Qualifications: Bachelor degree, MBA is a plus Leadership Competencies: Growth mindset Strong communication skills and power of influence Supplier and stakeholder managementJob Required Competencies?5-10 year related procurement experience, must have experience in business partnering role? Innovative and willing to do something different Solid negotiation and cost management experience Strong analytical skill Good computer skill (PPT, Excel, Word) Solid presentation skills Fluent English both in written and oral
    • shanghai, shanghai
    • contract
    • CNY30,000 - CNY50,000 per year
    1、完善财务核算体系,对财务核算工作进行监督及管理,提升账务工作质量;3、规划、组织、实施公司财务管理工作,组织进行财务分析、资金管理,为业务决策、评价提供高价值的财务支持;4、负责公司预算体系建立、编制、执行与控制工作;5、对公司税收进行整体筹划与管理, 按时完成税务申报工作;6、配合三方中介推进IPO财务相关工作,确保上市进程的顺利推进;7、搭建内控框架体系,配合IPO内控审计;8、参与重大经济合同或协议的审查,进行财务风险控制。要求:1、4-5年四大审计+企业财务工作经验;2、医疗器械行业经验、港股IPO经验及CPA/ACCA优先。
    1、完善财务核算体系,对财务核算工作进行监督及管理,提升账务工作质量;3、规划、组织、实施公司财务管理工作,组织进行财务分析、资金管理,为业务决策、评价提供高价值的财务支持;4、负责公司预算体系建立、编制、执行与控制工作;5、对公司税收进行整体筹划与管理, 按时完成税务申报工作;6、配合三方中介推进IPO财务相关工作,确保上市进程的顺利推进;7、搭建内控框架体系,配合IPO内控审计;8、参与重大经济合同或协议的审查,进行财务风险控制。要求:1、4-5年四大审计+企业财务工作经验;2、医疗器械行业经验、港股IPO经验及CPA/ACCA优先。

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