Combo卡问题# EB23 - 劳工卡
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【 以下文字转载自 Biology 讨论区 】
发信人: JoyceS (JoyceS), 信区: Biology
标 题: Global leading pharma招聘：【Medical Writer】地点：上海
关键字: Medical Writer Clinical
发信站: BBS 未名空间站 (Thu May 8 10:39:05 2014, 美东)
请联系Joyce：d******[email protected]
欢迎有相关经验者，或医药背景应届硕士积极申请，英文要求精通
也非常欢迎想回国发展的其他专业人士联系
POSITION SUMMARY 职位概要
Medical Writers collaborate with Point of Contact medical writers (PoC), and
members of the clinical study team in Development Sites overseas to
interpret study results and prepare Clinical Study Reports (CSRs) and
related documents. The scope of the work includes global and regional
studies across all phases of human development. The writers work closely
with biostatisticians and clinicians to ensure the study analysis results
and statistical interpretations are accurately and clearly reflected in the
CSR.
KEY RESPONSIBILITIES
Preparation, review and finalization of CSRs or related documents
Collaboration with biostatisticians and clinical colleagues to interpret
study results and ensure timely and accurate integration of data presented
in the statistical tables and listings and other information sources into
the CSR
Active participation on clinical study teams in the development of clinical
study documents
Ensure that all medical writing deliverables are prepared according to
International Conference on Harmonisation (ICH) and other relevant
regulatory guidelines
Ensure documents are generated in accordance with agreed internal processes
and standards (eg Global Document Style Guide), are submission ready and
appropriately stored in an agreed document management system
Ensure that appropriate quality control (QC) checks are performed on CSRs,
other regulatory documents and other medical writing deliverables, as
required
Provide thorough and critical review or peer QC support, of documents
prepared by others, as needed
Ensure own work processes are constantly improved to reflect lessons learned
from previous experiences
May participate in CRDC initiatives to increase efficiency and productivity
ORGANISATIONAL RELATIONSHIPS
Internally to the Medical Writers have strong working relationships with:
PoC medical writers at the commissioning site
Clinicians
Biostatisticians
Programmers and PoC Programmers
Data managers
Clinical study managers
Clinical project managers
Document Specialists
Quality assurance auditors
ESSENTIAL CHARACTERISTICS 基本要求
Education学历要求
At least bachelor degree or equivalent in medical related or life sciences.
医学或生命科学大学本科及以上
Experience
Knowledge/experience of preparing ICH E3 compliant study reports or medical
regulatory documents as a medical writer within or for the pharmaceutical /
healthcare / regulatory industry
Technical Competencies技术要求
Excellent verbal and written English language skills
Demonstrable ability to communicate clinical data succinctly, clearly and
accurately in writing, in English
能够用书面简明，清晰，正确地进行临床数据方面的沟通
Knowledge of ICH guidelines and regulatory requirements and demonstrable
ability to interpret and apply these guidelines in a report writing setting
熟悉ICH 指导方针和新药注册申报法规要求
Basic knowledge of using Windows OS, MS-Word, MS-Excel, E-Mail (MS-Outlook)
Basic experience of working in electronic document management systems.
DESIRABLE CHARACTERISTICS 希望具有的特征
Education学历要求
Post-graduate degree (Masters) or education from universities overseas.
研究生或毕业于海外大学
Technical Competencies技术能力
Ability to present with similar ease to both scientific and non-scientific
audiences.
Expertise of interacting with cross functional study teams
Experience of writing Phase 1 to 4 clinical study reports as a medical
writer in the pharmaceutical/healthcare industry for at least 2 years.
Behavioural Competencies行为能力
Demonstrable communication skills in a variety of media settings (e.g.
teleconference).
具备远程电话会议沟通能力
发信人: JoyceS (JoyceS), 信区: Biology
标 题: Global leading pharma招聘：【Medical Writer】地点：上海
关键字: Medical Writer Clinical
发信站: BBS 未名空间站 (Thu May 8 10:39:05 2014, 美东)
请联系Joyce：d******[email protected]
欢迎有相关经验者，或医药背景应届硕士积极申请，英文要求精通
也非常欢迎想回国发展的其他专业人士联系
POSITION SUMMARY 职位概要
Medical Writers collaborate with Point of Contact medical writers (PoC), and
members of the clinical study team in Development Sites overseas to
interpret study results and prepare Clinical Study Reports (CSRs) and
related documents. The scope of the work includes global and regional
studies across all phases of human development. The writers work closely
with biostatisticians and clinicians to ensure the study analysis results
and statistical interpretations are accurately and clearly reflected in the
CSR.
KEY RESPONSIBILITIES
Preparation, review and finalization of CSRs or related documents
Collaboration with biostatisticians and clinical colleagues to interpret
study results and ensure timely and accurate integration of data presented
in the statistical tables and listings and other information sources into
the CSR
Active participation on clinical study teams in the development of clinical
study documents
Ensure that all medical writing deliverables are prepared according to
International Conference on Harmonisation (ICH) and other relevant
regulatory guidelines
Ensure documents are generated in accordance with agreed internal processes
and standards (eg Global Document Style Guide), are submission ready and
appropriately stored in an agreed document management system
Ensure that appropriate quality control (QC) checks are performed on CSRs,
other regulatory documents and other medical writing deliverables, as
required
Provide thorough and critical review or peer QC support, of documents
prepared by others, as needed
Ensure own work processes are constantly improved to reflect lessons learned
from previous experiences
May participate in CRDC initiatives to increase efficiency and productivity
ORGANISATIONAL RELATIONSHIPS
Internally to the Medical Writers have strong working relationships with:
PoC medical writers at the commissioning site
Clinicians
Biostatisticians
Programmers and PoC Programmers
Data managers
Clinical study managers
Clinical project managers
Document Specialists
Quality assurance auditors
ESSENTIAL CHARACTERISTICS 基本要求
Education学历要求
At least bachelor degree or equivalent in medical related or life sciences.
医学或生命科学大学本科及以上
Experience
Knowledge/experience of preparing ICH E3 compliant study reports or medical
regulatory documents as a medical writer within or for the pharmaceutical /
healthcare / regulatory industry
Technical Competencies技术要求
Excellent verbal and written English language skills
Demonstrable ability to communicate clinical data succinctly, clearly and
accurately in writing, in English
能够用书面简明，清晰，正确地进行临床数据方面的沟通
Knowledge of ICH guidelines and regulatory requirements and demonstrable
ability to interpret and apply these guidelines in a report writing setting
熟悉ICH 指导方针和新药注册申报法规要求
Basic knowledge of using Windows OS, MS-Word, MS-Excel, E-Mail (MS-Outlook)
Basic experience of working in electronic document management systems.
DESIRABLE CHARACTERISTICS 希望具有的特征
Education学历要求
Post-graduate degree (Masters) or education from universities overseas.
研究生或毕业于海外大学
Technical Competencies技术能力
Ability to present with similar ease to both scientific and non-scientific
audiences.
Expertise of interacting with cross functional study teams
Experience of writing Phase 1 to 4 clinical study reports as a medical
writer in the pharmaceutical/healthcare industry for at least 2 years.
Behavioural Competencies行为能力
Demonstrable communication skills in a variety of media settings (e.g.
teleconference).
具备远程电话会议沟通能力
