Job Title: Publishing and Product License Support Intern (CRDC)

Dept.: Publishing and Product License Support (PPLS)

Term: at least 6 Months

Vacancy: 1

General Job Description:

• Support Safety calls for contribution received for various Aggregate Safety Reports and collect correlative information to facilitate Global Regulatory Leads’ review and PSSR Analyst’s contributions.
• Delivery of electronic regulatory transactions and post market scheduled regulatory compliance activities in accordance with 21CFR 314.81 and 21CFR 314.80 via Pfizer submission management tools and systems.
• Responsible for managing tracking and preparation of post-marketing Annual Report (NDA AR) that are submitted to the U.S. Food and Drug Administration within agreed timelines.
• Other business needs to ensure business compliance

Job Requirements:

• University student, preferably majoring in Pharmacy, Biology, Life Science, Business or Information Technology or other related fields;
• In depth knowledge of drug development and regulation;
• Fluent in English listening, reading, writing and speaking;
• Computer literacy in MS Word/Outlook/Excel/Adobe Acrobat;
• Proven technical aptitude and ability to quick learn and use new soft wares, regulations and quality standards;
• Ability to work with accuracy and attention to details;
• Quick learner with ability to multi-tasks;
• Preferred to work at least 4 full days a week;
• Internship duration: at least 6 months.

上班地址：张江高科