由买买提看人间百态

boards

本页内容为未名空间相应帖子的节选和存档,一周内的贴子最多显示50字,超过一周显示500字 访问原贴
JobMarket版 - [招聘2个职位] Drug Regulatory Affairs-CMC and Scientific Writing
相关主题
招聘 Project Manager - Drug Regulatory Affairs (转载)Job oportunity in Beijing 30-50万年薪
诚聘 Scientist/Senior Scientist for Biology Process Development代友发:Scientist in DSP in Novo Nordisk R&D Center China
生物-化学-医药人才招聘 Base纽约Associate Director Position in a New Jersey Pharma Company
Senior Designer - eBay Seattle opening保诺(Bioduro) Formulation Director招聘 (China)
想海归烟台的吗?有蛋白质药物开发经验吗?广药集团广州白云山制药总厂招聘药剂学,分析化学博士 (转载)
某知名医药外企急招一个医药SAS的职位 (转载)Global leading pharma招聘:【Medical Writer】地点:上海
某知名医药外企急招一个医药SAS的职位诚招生物医药CRO公司的分析总监和制剂总监
China Opportunity _Principal Scientist or Sr. Scientist【内推】Senior Clinical Trial Manager
相关话题的讨论汇总
话题: 61623话题: regulatory话题: aleon话题: cmc话题: fda
进入JobMarket版参与讨论
1 (共1页)
m*********i
发帖数: 140
1
不要求经验,可用OPT, 支持H1B,绿卡申请。地点:Parsippany, NJ
两个职位,请看描述。请站内我或者直接发简历到招聘广告中的邮箱。
No.1:
Specialist/Manager, CMC Drug Regulatory Affairs
Job Type: Full-time
Job Responsibilities:
 Manage project planning, operation and reporting of assigned
projects. ​
 Represent company on project meetings with clients.
 Review Chemistry, Manufacturing and Controls (CMC) documents to
assure compliance
with FDA requirements and industry standards.
 Develop and communicate the regulatory CMC strategy and identify
key issues throughout
the project.
 Prepare IND and amendment submissions to the FDA.
 Study FDA regulation and guidance and prepare regulatory analysis
report.
Qualifications:
 PhD in Chemistry required (medicinal/pharmaceutical chemistry,
organic chemistry,
analytical chemistry, or related fields) from an accredited university or
college.
 Experience or understanding of drug development process.
 We are willing to train exceptional candidate(s) who can
demonstrate quality and potential.
Skills and Requirements:
 Strong organization, communication, and interpersonal skills is a
must
 Proactive and ambitious
 Can-do attitude
 Open-minded and creative
 Passionate desire to learn
 Excellent time management
 Outstanding leadership skills
 Ability to set priorities by working with senior management
 Capability to multi-task and meet challenging timelines
What We Offer to You:
 Countless opportunities to make a difference
 Limitless learning possibilities
 Friendly and positive work environment
 Dynamic company culture
 Aleon offers competitive compensation with many benefits, including
paid time
off, 401(k), profit sharing, health insurance, and much more
This is a great opportunity for candidates who seek to advance their career
to the next level as
Aleon offers many unique career advancement possibilities!
We are confident that you will find Aleon has a very rewarding and exciting
work
environment. If you feel that you are a good fit for this position and our
company culture,
email your resume with confidence to [email protected]
Winner of the prestigious 2018 Outstanding Employer Award by New Jersey
Business &
Industry Association.
Aleon Pharma International, Inc. is an equal opportunity employer.
Candidate must be authorized to work in the US.
No.2:
Specialist/Manager, Scientific/Regulatory Writing
Job Type: Full-time
Job Responsibilities:
 Prepare/review non-clinical study reports, clinical study protocols
, investigator’s brochures
(IBs), clinical reports, development safety update reports (DSURs), summary
documents, and
other submission related documents.
 QC regulatory documents for compliance with FDA/ICH requirements
and industry
standards.
 Ensure consistency of clinical documents to maintain quality
standards.
 Communicate directly with the sponsor on an ongoing basis to
resolve any errors or
inconsistencies with regulatory documents.
 Facilitate the finalization process of regulatory documents.
 Manage interactions with the sponsor and vendors throughout the
project.
Qualifications:
 Master/PhD in a scientific discipline (chemistry, biological
sciences, pharmaceutical, etc.).
 Knowledge of FDA regulatory guidelines and regulations.
 We are willing to train exceptional candidate(s) who can
demonstrate quality and potential.
Skills and Requirements:
 Strong organization, communication, and interpersonal skills is a
must
 Proactive and ambitious
 Can-do attitude
 Open-minded and creative
 Passionate desire to learn
 Excellent time management
 Outstanding leadership skills
 Ability to set priorities by working with senior management
 Capability to multi-task and meet challenging timelines
What We Offer to You:
 Countless opportunities to make a difference
 Limitless learning possibilities
 Friendly and positive work environment
 Dynamic company culture
 Aleon offers competitive compensation with many benefits, including
paid time
off, 401(k), profit sharing, health insurance, and much more
This is a great opportunity for candidates who is considering a career
change or seek to advance
their career to the next level as Aleon offers many unique career
advancement possibilities!
We are confident that you will find Aleon has a very rewarding and exciting
work
environment. If you feel that you are a good fit for this position and our
company culture,
email your resume with confidence to [email protected]
Winner of the prestigious 2018 Outstanding Employer Award by New Jersey
Business &
Industry Association.
Aleon Pharma International, Inc. is an equal opportunity employer.
Candidate must be authorized to work in the US.
1 (共1页)
进入JobMarket版参与讨论
相关主题
【内推】Senior Clinical Trial Manager想海归烟台的吗?有蛋白质药物开发经验吗?
国内知名药企的多个高级职位某知名医药外企急招一个医药SAS的职位 (转载)
国内制药公司中高级职位某知名医药外企急招一个医药SAS的职位
国内药企招CMC VPChina Opportunity _Principal Scientist or Sr. Scientist
招聘 Project Manager - Drug Regulatory Affairs (转载)Job oportunity in Beijing 30-50万年薪
诚聘 Scientist/Senior Scientist for Biology Process Development代友发:Scientist in DSP in Novo Nordisk R&D Center China
生物-化学-医药人才招聘 Base纽约Associate Director Position in a New Jersey Pharma Company
Senior Designer - eBay Seattle opening保诺(Bioduro) Formulation Director招聘 (China)
相关话题的讨论汇总
话题: 61623话题: regulatory话题: aleon话题: cmc话题: fda