Clinical Regulatory Affairs Associate III

  • location: North Chicago, IL
  • type: Contract
  • salary: $45 - $50.34 per hour
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job description

Clinical Regulatory Affairs Associate III

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!

 
location: North Chicago, Illinois
job type: Contract
salary: $45.00 - 50.34 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • With manager support, manages/provides operational oversight to ensure timely, high quality regulatory submissions. Participate in the development of project plans using established templates.
  • Plans and negotiates publishing timelines with the teams.
  • Effectively manages multiple projects and competing priorities.
  • Acts as primary Submission Operations interface with project teams providing guidance and communication of established submission processes and standards.
  • Plans and conducts submission team meetings.
  • Communicates effectively verbally and in writing with diverse audiences and across various levels within the organization.
  • Identify obstacles and work with manager/mentor to develop solutions for the team.
  • Participates in the development of optimal business processes and practices within the department to ensure high levels of customer support and to achieve high quality submissions.
  • Demonstrates submission team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
  • Position accountability/scope:

    • Some supervision of projects and assistance with priority setting required
    • Receives project assignments from manager but has responsibility for managing own projects
    • Reviews project progress with manager on a regular basis with direction provided on follow-up
    • Identifies opportunities for process improvements. May participate on internal project teams to update business processes.
 
qualifications:
  • Required Education

    • Bachelor's degree.
    • PMP and RAC certificates a plus
  • Required Experience

    • 4 years pabbviharmaceutical or industry related experience
    • Experience working in a complex and matrix environment
    • Strong communication skills both oral and written
  • Preferred Experience:

    • Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area
    • Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
 
skills: Quality Assurance, PMP, Regulatory Affairs Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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