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Job Requirements of Regulatory Affairs Ops Specialist I:
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Employment Type:
Contractor
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Location:
Deerfield, IL (Onsite)
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Regulatory Affairs Ops Specialist I
Careers Integrated Resources Inc
Deerfield, IL (Onsite)
Contractor
Job Title: Regulatory Affairs Ops Specialist I
Job Location: Deerfield, IL
Job Duration: 11-12 Months (possibility of extension)
Payrate: $46.00/ hr on w2
Description:
Job Location: Deerfield, IL
Job Duration: 11-12 Months (possibility of extension)
Payrate: $46.00/ hr on w2
Description:
- This section focuses on the main purpose of the job in one to four sentences.
- Under limited supervision responsible for the implementation of regulatory strategies, and resolution of issues pertaining to documents/ packages for regulatory submissions.
- Produces and evaluates technical and scientific data necessary for regulatory submissions.
- Assists in the implementation and delivery of new or upgraded systems and processes in support of companies products.
- This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.
- The incumbent will perform other duties assigned.
- Document all system related issues, and identify resolutions
- Document complex processes and create and manage documentation related to validated systems.
- Participate in identifying solution to meet requirements for systems.
- Participate in system upgrades to assure integrity of data is maintained.
- Assure adequate access and functioning of system tools and version upgrades
- Provides expertise in ongoing maintenance of electronic record receipt and submission to regulatory authorities.
- Participate as an active team member and provide expertise to project teams as required May verify the maintenance of support systems, libraries and dictionaries
- Maintain awareness of regulatory requirements and evaluate potential impact to company To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- Detail oriented.
- Technical system skills (e.g. word processing, spreadsheets, databases, online research)
- Written and verbal communication skills.
- Knowledge of applicable regulations.
- Excellent organizational skills and ability to support multiple projects.
- Ability to contribute to multiple projects from an operations perspective.
- Work independently with minimal direct supervision.
- Strong negotiation and collaboration skills.
- Manage multiple projects and deadlines.
- Ability to identify compliance risks and resolve or escalate when necessary
- Experience in addressing complex problems or processes Include the education and experience that is necessary to perform the job satisfactorily.
- Bachelor’s Degree or country equivalent with a minimum of 5 years in a regulated environment.
- Scientific or related discipline would be an advantage.
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