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19 days old

Regulatory Affairs Associate (Ad Promo)

Kelly Services
Deerfield, IL 60015
PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship.


Kelly Science & Clinical is seeking a Regulatory Affairs Associate to join their team in Deerfield, IL/Remote for an American multinational health care company that primarily focuses on products to treat hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions. For immediate consideration, please email your resume directly to: Regan.Brown@KellyServices.com as well as apply online.


**Regulatory Affairs Associate III**


**~12 Months/1 Year (contract to hire for the right candidate W2)**

**Pay Rate: BOE/TBD**


PLEASE NOTE: Remote to start, post COVID onsite Deerfield, IL.


Summary:

Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions, analyze metrics related to internal processes (advertising and promotion). Review and evaluate technical and scientific data and reports in support of Baxters products and processes.


Essential Duties & Responsibilities:


+ Track of status and progress of regulatory documentation.

+ Review, edit and proofread regulatory documentation.

+ Assist in preparation and review of labeling, SOPs, and other departmental documents.

+ Compile regulatory documents for FDA submission (eCTD experience preferred).

+ Participate as an active team member of project teams as required.

+ Compile and prepare responses to regulatory authorities questions.

+ Maintain regulatory files in a format consistent with requirements.

+ Maintain awareness of regulatory requirements.

+ Develop training material and liaise with cross function teams.

+ Administrative responsibilities related to management of internal global process (i.e. Advertising and promotion process).


Qualifications:


+ Strong written and verbal communication skills, ability to organize, prioritize and meet deadlines.

+ Strong analytical skills, including digital competency.

+ Knowledge of regulations for US FDA submission.

+ Strong technical systems skills (e.g. word processing, excel spreadsheets, databases, online research).

+ Proofreading and editing skills.

+ Ability to contribute to multiple projects from a regulatory affairs perspective.

+ Ability to multitask and problem solve.

+ Experience with Veeva software (i.e. Zinc or PromoMats) regarding review of promotional material.


Education/Experience:


+ Minimum of a completed bachelors degree or country equivalent required.

+ 3-5 years of pharmaceutical industry experience.

+ 3-5 years of regulatory experience preferred; concentration in life sciences, technical/engineering or related field preferred.

+ 3-5 years AdProm experience.


**Why Kelly:**


+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies.

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career.

+ Access to more than 3,000 online training courses through our Kelly Learning Center, including accredited courses to obtain IT certifications, as well as PDU-approved courses.

+ Weekly pay.

+ Group-rate insurance options available immediately upon hire.*


**Apply today!**


**Refer a friend!**


*Available for purchase and administered by a designated third-party vendor. (68.40)


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


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-05-26 Expires: 2021-07-08

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Regulatory Affairs Associate (Ad Promo)

Kelly Services
Deerfield, IL 60015

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