【 以下文字转载自 JobMarket 讨论区 】
发信人: michaeladai (adai), 信区: JobMarket
标 题: [招聘2个职位] Drug Regulatory Affairs-CMC and Scientific Writing
发信站: BBS 未名空间站 (Thu Nov 29 18:25:22 2018, 美东)
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.
