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Regulatory Operations Associate

Kelly Services


Location:
Seattle, WA
Date:
04/18/2018
2018-04-182018-05-17
Job Code:
US15TPKS_BH1431708
Kelly Services
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Job Details

Job Title Regulatory Operations Associate

Jobid US15TPKS_BH1431708

Location: Seattle, WA, 98194, USA

Description Kelly Scientific is currently hiring **Regulatory Operations Associate** position to work at a biotech company based in Seattle, WA. The Regulatory Operations Associate will prepare documents for submission, including safety reports and IND amendments, and will perform a number of tracking and reporting functions to support Regulatory Operations.

This is a 1 year contract.

**Job Duties**


+ Tracks and compiles submission component documents from paper and/or electronic sources; edits, formats, assembles, and publishes submission documents in accordance with established timelines.
+ Ensures completion of high-quality submissions in electronic (eCTD) and paper format for compliance with all applicable regulations, guidance’s, and Regulatory Operations document specifications.
+ Assists submission authors and regulatory liaisons in the planning and preparation of regulatory submissions; when appropriate, composes regulatory forms, correspondence, and text.
+ Assists in the development of and implements documentation standards, templates, and procedures related to the formatting, publishing, and archiving of both electronic (eCTD) and paper submissions.
+ Archives/retrieves archived regulatory documents (both paper and electronic) as necessary.
**Education and Qualifications**


+ Bachelor’s degree in a relevant technical or scientific field preferred.
+ High level of proficiency in Microsoft Office and Adobe Acrobat software **required** . Proficiency with StartingPoint templates a plus.
+ Proficiency in eCTD format and FDA submission requirements.
+ 1 - 3 years of experience with eCTD publishing software preferred.
+ Familiarity with technologies (e.g., eCTD systems, ESG, XML) to support electronic submissions and labeling required.
+ Strong communications and teamwork skills required. Attention to detail a must.
+ Ability to multitask and switch gears quickly.
+ 3 years of pharmaceutical experience preferred.
**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 kellyservices.com 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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