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Clinical Project Lead II
Ref No.: 18-01136
Location: Cambridge, Massachusetts
Position Type:Contract
Start Date / End Date: 05/07/2018 to 05/07/2019
•Manage, prepare and review regulatory document packages necessary for affiliates to renew or apply for marketing approvals
•Prepare and assemble content to be legalized or apostilled for different countries
•Close interaction with Genzyme, Sanofi and Pasteur regulatory personnel
•Knowledge of Regualtory Affairs a plus
•RAC certification also a plus
Experience prefered: 3 - 5 years of work experience in regulatory

•Specific or working knowledge of US Drug and Medical Devices regulatory
•Excellent organizational and communication (written and verbal) skills
•Proficient in MS Word, Excel, Outlook for email and meetings
•Excellent in English language (written and verbal) skills
•Foreign language skills a plus, especially Spanish
•Excellent organizational skills

College or University bachelors degree, Masters degree a plus