Medical Advisor
博福--益普生(天津)制药有限公司
- 公司规模:500-1000人
- 公司性质:合资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2012-08-31
- 工作地点:北京
- 招聘人数:2
- 学历要求:本科
- 语言要求:英语良好
- 职位类别:其他
职位描述
Responsibilities:
Primary Purposes of Position:
According to the requirements of Group SOP and government regulation, finish protocol design of post marketing study, medical training, medical information and promotional material management for the product line belongs to Gastroenterology & Neurology Therapeutic Area assure that the outcome of these works meets company's demand of promotion and marketing.
Main Duties to be performed:
-Guarantee the progress and quality of from protocol design side in Gastroenterology & Neurology Therapeutic Area could meet the highest requirements of Group and SFDA from feasibility evaluation, documentation to quality and progress including pre-launch and post marketing clinical trial.
-Guarantee the progress and quality of non-clinical medical projects in relevant Therapeutic Area meet the requirements of company business.
-Guarantee the appropriate management of medical information of Gastroenterology & Neurology Therapeutic Area as an internal consultant and a scientific reviewer for promotion tools.
-Guarantee the management of MR training of Gastroenterology & Neurology Therapeutic Area with training team.
Specifics of Position:
In clinical projects
-Develops protocol, CRF, review ICF and statistical analysis plan.
-Develops standard training material, is involved in training study team members and site satff on medical aspects of the study, and provides support for medical topics and questions.
-Reviews clinical data, attends data review meeting, approves final patient validity.
-Reviews statistical tables, identifies additional analyses, interprets clinical data, prepares CSR.
-Contributes to regulatory INA and NDA submissiona and clinical publications.
-Prepares the medical section of briefing documents for discussions/meetings with regulatory authorities.
-Develops responses to study-specific medical issues that may be raised by regulatory agencies.
-Collaborate effectively with Global and local teams in the execution of relevant clinical activities, including initial input in protocols and ongoing medical support.
In non-clinical projects
-Set up proposal via communication with relevant BU including background, objective, specification, timeline and budget, etc.
-Prepare project plan.
-Be responsible for implementation.
In marketing support
-Act a resourceful partner to marketing to bring input in the medical/marketing strategies, discuss and challenge the medical/marketing contents of the operational plans with marketing to reach mutual alignment, and a stronger "medicalization" of the marketing mix.
-Develop and update medical knowledge of relevant BU and ensure its training/circulation.
-Provide support for Publications of study.
-Development of scientific contacts with clinicians, medical and patient support organizations. The role involves a mixture of research and educational initiatives intended to improve external customers' scientific knowledge.
-Contribute medical, clinical expertise and scientific advice to all allied departments.
-Evaluate feasibility of new launch product with Marketing and clinical team.
-Review, and approve promotional and training material tailored to the needs of the product and according to SOP, RDPAC policy and local regulations
-Provide comprehensive product related disease and therapies presentations and training to internal and external customers.
Requirements:
-Bachelor degree or above with major in Medical Science.
-Excellent written and oral communication skills in English.
-1-2 years clinical experience in relevant therapeutic area or 3 years working experience in international pharmaceutical enterprise.
-Teamwork and collaboration with others.
Please send your resumes both in English and Chinese to this email: hr.china@ipsen.com.
Primary Purposes of Position:
According to the requirements of Group SOP and government regulation, finish protocol design of post marketing study, medical training, medical information and promotional material management for the product line belongs to Gastroenterology & Neurology Therapeutic Area assure that the outcome of these works meets company's demand of promotion and marketing.
Main Duties to be performed:
-Guarantee the progress and quality of from protocol design side in Gastroenterology & Neurology Therapeutic Area could meet the highest requirements of Group and SFDA from feasibility evaluation, documentation to quality and progress including pre-launch and post marketing clinical trial.
-Guarantee the progress and quality of non-clinical medical projects in relevant Therapeutic Area meet the requirements of company business.
-Guarantee the appropriate management of medical information of Gastroenterology & Neurology Therapeutic Area as an internal consultant and a scientific reviewer for promotion tools.
-Guarantee the management of MR training of Gastroenterology & Neurology Therapeutic Area with training team.
Specifics of Position:
In clinical projects
-Develops protocol, CRF, review ICF and statistical analysis plan.
-Develops standard training material, is involved in training study team members and site satff on medical aspects of the study, and provides support for medical topics and questions.
-Reviews clinical data, attends data review meeting, approves final patient validity.
-Reviews statistical tables, identifies additional analyses, interprets clinical data, prepares CSR.
-Contributes to regulatory INA and NDA submissiona and clinical publications.
-Prepares the medical section of briefing documents for discussions/meetings with regulatory authorities.
-Develops responses to study-specific medical issues that may be raised by regulatory agencies.
-Collaborate effectively with Global and local teams in the execution of relevant clinical activities, including initial input in protocols and ongoing medical support.
In non-clinical projects
-Set up proposal via communication with relevant BU including background, objective, specification, timeline and budget, etc.
-Prepare project plan.
-Be responsible for implementation.
In marketing support
-Act a resourceful partner to marketing to bring input in the medical/marketing strategies, discuss and challenge the medical/marketing contents of the operational plans with marketing to reach mutual alignment, and a stronger "medicalization" of the marketing mix.
-Develop and update medical knowledge of relevant BU and ensure its training/circulation.
-Provide support for Publications of study.
-Development of scientific contacts with clinicians, medical and patient support organizations. The role involves a mixture of research and educational initiatives intended to improve external customers' scientific knowledge.
-Contribute medical, clinical expertise and scientific advice to all allied departments.
-Evaluate feasibility of new launch product with Marketing and clinical team.
-Review, and approve promotional and training material tailored to the needs of the product and according to SOP, RDPAC policy and local regulations
-Provide comprehensive product related disease and therapies presentations and training to internal and external customers.
Requirements:
-Bachelor degree or above with major in Medical Science.
-Excellent written and oral communication skills in English.
-1-2 years clinical experience in relevant therapeutic area or 3 years working experience in international pharmaceutical enterprise.
-Teamwork and collaboration with others.
Please send your resumes both in English and Chinese to this email: hr.china@ipsen.com.
公司介绍
益普生集团是一家专注在药物创新和肿瘤病学、神经科学以及罕见病学领域的国际生物制药公司。我们有完善和成功的消费者保健业务,始终致力于通过发现新的疾病解决方案来提高患者的生活质量。从家族企业到上市集团,我们已经走过90年的历史,益普生集团拥有20种产品,销往网络遍布于115个国家,并在其中30多个国家直接设立了商业公司。2019年的总销售额超过25亿欧元,其中在欧洲达到了两位数的增长,在北美增长了20%。我们专注于以Decapeptyl?为代表的肿瘤病学、Dysport?为代表的神经科学以及罕见病学为主导的专科疾病领域,且在多元健康业务领域也有卓越表现。目前我们在全球范围内拥有逾5700名员工,建立了8家研发中心和8个生产厂。值得骄傲的是,2018年我们将13.5%的销售额投入到研发。在肿瘤病学领域,我们是全球排名前14的生物制药公司。
1992年,益普生进入中国并在天津成立代表处开展业务,随后于1997年在天津华苑产业园区成立合资企业博福-益普生(天津)制药有限公司。经过了逾23年的稳健发展,中国已经成为益普生集团在全球范围的第二大市场。随着益普生集团整体发展战略的清晰化,特别是随着销售额和市场需求的不断攀升,2015年5月益普生(天津)医药商贸有限公司在天津成立。2010年4月,益普生(北京)医药商贸有限公司在北京成立,2020年4月益普生(上海)成立。
在中国,益普生借助其明星产品思密达成为了消化领域的领导企业,并且力争成为专业治疗领域内的领军者。益普生近期在中国所进行的Somatuline?和Dysport?的临床实验也推动了在专科领域特别是内分泌和神经领域的快速发展。另一个见证益普生在专科领域蓬勃发展的案例就是泌尿肿瘤类药物Diphereline?,一种服务于前列腺癌患者的领先药物。
1992年,益普生进入中国并在天津成立代表处开展业务,随后于1997年在天津华苑产业园区成立合资企业博福-益普生(天津)制药有限公司。经过了逾23年的稳健发展,中国已经成为益普生集团在全球范围的第二大市场。随着益普生集团整体发展战略的清晰化,特别是随着销售额和市场需求的不断攀升,2015年5月益普生(天津)医药商贸有限公司在天津成立。2010年4月,益普生(北京)医药商贸有限公司在北京成立,2020年4月益普生(上海)成立。
在中国,益普生借助其明星产品思密达成为了消化领域的领导企业,并且力争成为专业治疗领域内的领军者。益普生近期在中国所进行的Somatuline?和Dysport?的临床实验也推动了在专科领域特别是内分泌和神经领域的快速发展。另一个见证益普生在专科领域蓬勃发展的案例就是泌尿肿瘤类药物Diphereline?,一种服务于前列腺癌患者的领先药物。
联系方式
- Email:hr.china@ipsen.com
- 公司地址:杭州及周边地区