Specialist 1 - Regulatory Affairs

Company: Kelly
Location: Rosemont
Posted on: May 15, 2022

Job Description:

Regulatory Affairs Specialist - Part Time - hybrid Every day, Kelly Science & Clinical connects professionals with opportunities to advance their careers. We currently have exciting Temporary opportunity with a global leader in the production at Titusville NJ Job Description:

• Serves as a member of the Regulatory Operations team and delivers on the coordination of tasks, resources, and priorities impacting Regulatory Operations function, including aligning support to business needs e.g. submissions related to high-volume launches, safety updates, etc.
• Partners with business to ensure that emerging advertising and promotion technologies and mediums are consistent with applicable laws, regulations, guidelines and company policies related to the submission of advertising and promotion materials
• Continually evaluating the organization s ability to deliver value on reporting and insights and create deliver compliance value recommendations for change where applicable
• Serve on projects to streamline workflows within functional areas as assigned Foster partnerships to ensure that submissions are timely, accurate, and consistent with FDA requirements, ensure proper record keeping and retention of submission in the system, partner with the Law Department and external counsel to respond to litigation document requests
• Serve as an engaged member of the Regulatory Operations team with responsibilities for providing updates and driving consistency, engaging in strategy development, and providing oversight of projects and initiatives to advance the promotional compliance framework, including partnering to embed FDA requirements into the business and being responsible for engaging in a variety of tasks and initiatives, including many that call for sound judgment and independent initiative 'Strong experience with collaborating with various business partners Qualifications Bachelor's degree Regulatory experience preferred Why Kelly? Kelly-sponsored Affordable Care Act health care coverage available for eligible employees Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchase-and the coverage is portable Service bonus plan Holiday pay plan Weekly electronic pay options Free online training campus available Employee assistance program (EAP) available at no cost Corporate discounts Location: Titusville, NJ 08560 Hours: 9am-1pm - 20 hours (flexibility if possible) - 3 days onsite, 2 days remote Please send your resumes: 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 interests-it's 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, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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. ]]

Keywords: Kelly, Trenton , Specialist 1 - Regulatory Affairs, Other , Rosemont, New Jersey