29 days old

Regulatory Project Manager

Kelly Services
North Chicago, IL 60064
**Seeking a Project Manager II for a 5 month assignment in North Chicago, IL.**

Assists Immunology Global Regulatory Strategy group with administrative tasks across all assets

Support the GRL with regards to safety reporting and annual reporting (e.g., DSUR, PSUR, BLA, NDA, PMR) which may include working with cross-functional groups to obtain required information to complete annual updates for the PSURs for marketed products, DSURs, post-marketing commitment and requirement annual reporting, and Investigational Brochures for assigned products

Under the direction of the GRL, coordinate and provide input to responses to Competent Authorities or PRAC and/or CHMP safety questions, ad-hoc safety??related labeling changes, and significant safety events

Assist GRL in conducting surveys to countries which may include assessing global regulatory requirements for whether a change requires reporting, the type of reporting, or the reporting requirements for significant safety events

Complete submissions of DSURs and PSURs to US INDs and BLAs/NDAs under direction of GRL or US/C Lead

Track US/C Agency questions in HAQIT across TA for US/C Leads

Assist with US/C leads with submission documents such as financial disclosure, user fees, and Notes to reviewers

Under the direction of the GRL, maintain the Closed Loop trackers for assigned products

Manage the sharepoint sites to ensure update to date, organized, accurate and accessible information

Responsible for consultant management and invoice approvals

Responsible for Trial Master Verification process (with oversight from GRL)

AdComm set up with 3D: connect entries for US/C leads, invoice tracking, coordinate kickoff meetings

Assist with Staff Meeting Set Up

Retrieve non-urgent documents from eDocs


Bachelor's Degree

5-10 years regulatory affairs experience as a project manager or strategic planner. Organized and has exceptional follow up capabilities.

Able to balance competing priorities

Adaptability and Organization

Microsoft Office

SharePoint Experience

Nice to have: Edocs or regulatory systems experience, experience with databases, Veeva experience


**For immediate consideration, please send your resume in a WORD document to**

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

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

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at
Posted: 2019-12-20 Expires: 2020-01-20

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Regulatory Project Manager

Kelly Services
North Chicago, IL 60064

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