Kelly Services Project Manager in Madison, New Jersey
At Kelly® Professional we’re passionate about helping you find a job that works for you. We are hiring for a project manager in Madison, NJ
1 year contract, Possibly 1-2 days remote but three days / week is required to be onsite
This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
• Carries out managerial responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• Directs, coordinates and prioritizes the daily activities of assigned products
• Prepares, reviews and approves regulatory submissions (i.e. NDAs, amendments, annual report, supplements, etc.) to the Food and Drug Administration (FDA) to ensure compliance with applicable regulations and guidance’s.
• Interacts with various departments as needed on regulatory issues and/or strategy. Effectively guides, communicates and implements determined strategy with the appropriate departments and/or employees.
• Review and approve change labeling and core safety document changes
• Implements policies to assure on-going compliance of Regulatory Affairs activities.
• Assesses impact of new regulations and suggests appropriate changes to business processes/policies as necessary.
• Interacts with the FDA to facilitate approval of the regulatory submissions.
• Maintains awareness of all regulatory activities on assigned projects. Works to minimize regulatory issues and helps prevent unnecessary regulatory delays.
• Meets project deadlines and established performance standards.
• Complies with all Company policies and procedures, including safety rules and regulations, and guides subordinates in this area.
• Performs related duties as assigned and any required updates to trackers or routine reports as applicable
5 Years of Reg. Affairs Experience at minimum, Bachelors Degree at a minimum
• FDA, ICH, SOP and cGMP standards, guidelines and regulatory compliance regulations.
•Annual reporting process and requirements for routine submissions and Pertinent Federal and State laws related to pharmaceutical regulatory affairs.
• Supervision and training practices and methods.
• Business, scientific and personal computer software applications.
• Business English usage such as, spelling, grammar and punctuation.
• Company policies, practices and procedures, including safety rules and regulations.
• Principles and practices of budget preparation and administration.
What happens next
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what’s next in your career is what we’re all about, so let’s get to work. Apply today!
Why Kelly ® ?
You’re looking to keep your career moving onward and upward, and we’re here to help you do just that. Our financial staffing experts will connect you with premier companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in in your career. It all adds up.
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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.