Experienced Regulatory Project Manager

Join a full service clinical contract research organization with a rapid pace of growth

  • Cincinatti, OH
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A bit about us:

We are a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.

Why join us?

When you join, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

We are continuing to grow in all areas globally and has built an expansive research campus at headquarters and expanding other locations across the country

Perks (vary by location and position):
  • On-site fitness center(s)
  • Campus walking paths
  • Company-sponsored social and wellness events
  • Official Sponsor of FC Cincinnati
  • Hybrid work-from-home options and flexible work schedule
  • On-site Market Place
  • Free and covered parking
  • Discounts for local businesses
  • On campus restaurants and banks coming soon

Awards:
  • Recognized by Forbes as one of America's Best Mid-size Companies in 2021
  • We rank amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

Job Details

Our corporate activities are growing rapidly, and we are currently seeking a full-time, Experienced Regulatory Project Manager. This person will be a key member of Regulatory Affairs project teams to accomplish tasks and projects that are instrumental to the company’s success. With this opportunity, you will be able to leverage previous expertise and continue to develop and grow your career even further within the drug development industry.

Responsibilities

  • This position is for experienced candidates;
  • Support portfolio management for Sponsors;
  • Partner with cross-functional teams to execute Sponsor programs;
  • Engage in the preparation and maintenance of regulatory submissions and files;
  • Assign projects or activities, provide day-to-day instructions, and suggested training activities to direct reports, as needed;
  • Coordinate project start-up activities, track and report project status, and maintain project documentation such as communication plans, submission timelines, and task orders/scopes of work;
  • Serve as the primary point of contact for Sponsors and regulatory authorities;
  • Maintain comprehensive project timelines including projects with multiple regulatory submissions;
  • Escalate changes in scope following communication with the project team;
  • Schedule and lead internal and external project team meetings;
  • Prepare presentation materials for project team meetings such as internal and sponsor facing kick-off meetings;
  • Develop meeting agendas and minutes for project team meetings;
  • Work closely with other Regulatory Affairs project team members such as Regulatory Strategy Leads, Regulatory Science Managers, Medical Writers, and Regulatory Document Specialists to execute project plans;
  • Report project metrics and perform project close-out activities;
  • Maintain clear and effective Sponsor communication, identify and anticipate possible issues and/or challenges, and work with the project team to develop solutions;
  • Maintain close collaboration, interaction, and effective working relationships with our functional area colleagues;
  • Attend clinical operations internal meetings as the Regulatory Affairs representative;
  • Support other department initiatives, as needed.

Qualifications

  • Bachelor’s Degree in life sciences required; Master’s Degree preferred.
  • 5+ years of biopharma or CRO regulatory affairs experience.




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Job Details
Managed by Jobot Pro
Location
Cincinatti, OH
Job Type
Permanent