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发帖数: 140 | 1 【 以下文字转载自 Biology 讨论区 】
发信人: michaeladai (adai), 信区: Biology
标 题: 招聘 Project Manager - Drug Regulatory Affairs (转载)
发信站: BBS 未名空间站 (Tue Aug 21 19:11:34 2018, 美东)
发信人: michaeladai (adai), 信区: JobHunting
标 题: 招聘 Project Manager - Drug Regulatory Affairs
发信站: BBS 未名空间站 (Tue Aug 21 19:08:59 2018, 美东)
不要求经验，可用OPT, 支持H1B，绿卡申请。
Specialist/Project Manager - Drug Regulatory Affairs
Job Responsibilities:
• Prepare IND and amendment submissions to the FDA.
• Maintain professional communication with FDA.
• Study FDA/ICH/EMA regulation and guidance and prepare regulatory due
-diligence
analysis.
• Learn to develop strategy for new drug/biologics development.
• Manage project planning, operation and reporting of assigned
projects.
• Represent company on project meetings with clients/CROs.
• Prepare / review technical documents to assure compliance with FDA
requirements and
industry standards.
• Work in a cooperative manner with coworkers and customers.
Qualifications:
• PhD in Pharmaceutical/Biological Sciences (pharmacology/toxicology/
pharmacokinetics
preferred); PharmD also acceptable.
• Experience/training in regulatory affairs preferred. We are willing
to train exceptional
candidates who can demonstrate quality and potential.
Skills and Requirements:
• Excellent interpersonal, written and oral communication skills.
• Strong desire to learn.
• Ability to thrive in a dynamic and fast-paced environment.
• Attention to details.
• Capability to multi-task and meet challenging timelines.
• Exceptional attention to detail and excellent organizational skills.
• Be creative.
What We Offer to You:
• Aleon offers competitive compensation with many benefits, including
paid time
off, 401(k), profit sharing, health insurance, and many more.
• Limitless learning possibilities, and fantastic career advancement
opportunities.
• Friendly and positive work environment.
• Dynamic company culture.
• Countless opportunities to make a difference.
Winner of the 2018 Outstanding Employer Award by New Jersey Business &
Industry
Association.
Email your resume with confidence to
[email protected]
Aleon Pharma International, Inc. is an equal opportunity employer.
Candidate must be authorized to work in the US. |
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