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17 days old

Regulatory Affairs Specialist

Kelly Services
Johnston, IA 50131
Kelly has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary position with a client that is seeking a **Regulatory Affairs Specialist out of Johnston, IA. If interested/available, please reach out to Bryan Heffley directly at bryh262@kellyservices.com.**


PAY: Negotiable W2


DURATION: 6 months


LOCATION: Johnston, IA


SCHEDULE: Mon Fri


**Description:**


The CORE Data and Document Associate will provide critical support for important, and often time-sensitive, business needs such as activities associated with the annual planning and execution processes, data preparation/ quality checks and data analysis, essential regulatory submission-related requirements like redactions, and maintenance of regulatory documents.


**Key Support Responsibilities:**

_Submissions_ : Working with the Submission Excellence team, provides timely and accurate redactions for key regulatory submissions, often on tight timelines

_Planning and Data_ : With direction from the RAS Operations team, works with project plans and related financial data to analyze, report, and provide initial analyses for the customers

Provides reports to management as requested to display resource, expenses, metrics, activity information or other data as needed

Monitors plan quality and escalates areas of concern to leadership

During planning, assists with plan builds and updates as needed

Supports data clean-up and migration efforts to new planning and execution system

_Documentation_ : Assists with the development, updates, and reviews of best practices for various operational processes

Assist in gathering and centrally managing product supporting documentation as it becomes available

Provide conceptual indexing of proprietary reports through reading and analysis, identification of key concepts, standard vocabulary and chemical substance identifiers

Clarify and fulfill incoming indexing requests to capture information, confirm criteria and support data integrity through the identification and elimination of errors



**Degree and Skill Requirements:**

BS degree in chemistry, biology, engineering, or related scientific field or Business/ IT field or equivalent experience is preferred.

Previous scientific and/or regulatory experience is desired.

Excellent collaboration skills, including both written and oral, is a must

Strong attention to details and organizational skills are required.

Ability to maintain focus, effectively manage time, and deliver under aggressive timelines

Proficiency using MS Excel (including macros), Word, PowerPoint, SharePoint and Adobe Pro is necessary along with the aptitude to utilize other internal IT systems as needed.

Problem-solving

Continuous improvement mindset


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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: 2022-06-13 Expires: 2022-07-14

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Regulatory Affairs Specialist

Kelly Services
Johnston, IA 50131

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