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Regulatory Associate Pharmaceutical

Kelly Services

Indianapolis, IN
Job Code:
Kelly Services
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Job Details

Job Title Regulatory Associate Pharmaceutical

Jobid US33YEKB_BH1431485

Location: Indianapolis, IN, 46202, USA

Description Senior level Regulatory Associate position available with a pharmaceutical company in the Indianapolis area.

We are looking to hire someone with regulatory experience in medical device, biotech or with a pharmaceutical company

Long term contract position in the Global Safety department, managing adverse event reports from scientific literature.

This position also requires collaboration with internal and external customers to prepare quality periodic/annual safety summary reports; partners with Global Product Safety physicians to maintain and communicate product safety profile analyses to appropriate persons and groups (e. g. regulatory agencies.

Other responsibilities;

+ Provides support to global personnel regarding Global Product Safety policies, processes and procedures by updating SOPs, training tools/programs as necessary
+ Ensure regulatory compliance for expedited submission of case reports to regulatory authorities
+ Document in ECTD Express, an electronic technical document system
5+ years of Regulatory experience with global submission

Bachelor's degree

SharePoint, ECTD Express or Leo experience

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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