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Project Manager

Location: 

PA, US

Category:  General Management
Travel:  None

At C3i Solutions, we are committed to providing an incredible experience — that starts with you. When you join our team, you become part of a network across the world delivering solutions for the most trusted healthcare brands, every day.  As our company grows, we’re looking for you to grow with us. We want people who bring their own personality, strengths and talents to create something exceptional. People who will gain more experience than they could have ever imagined when they walked through the door. People who are ready to experience the world like never before. If you’re ready to experience opportunity, join us.

We have identified the need for a Project Manager to support the Office of Promotion and Review (OPAR) onsite Program. The Project Manager’s time will be allocated to the management of standards and processes used for developing and implementing promotion materials consistent with regulatory guidelines and supports business objectives. 

 

Primary Responsibilities:

  • Assists with the review and management of binder submissions for pre-clearance to the FDA.
  • Supports Global Standards and Services, US brand teams, franchises and Customer Solutions, Public Affairs and others to help assure promotional materials satisfy U.S. promotional regulations, corporate standards and policies and business objectives
  • May support regulatory activities, including confirming 2253 submission status (Y/N) and Tier compliance.
  • Assess promotional content review as appropriate.
  • Create or update supporting documentation to drive compliance with submission standards and metadata accuracy.
  • Supports activities generated from the Global Human Health Quality Management System initiative to ensure materials are of high quality and comply with standards, guidelines and regulations.
  • Supports deviation investigations and corrective actions and strives to make the process more efficient.
  • Performs routine consulting with promotion job owners on regulatory standards and process compliance.

 

Supervisory Responsibilities                        

This position has no supervisory responsibilities

 

The ideal candidate will possess the following skills and qualities:

  • Easily adaptable to a typically inconsistent work schedule
  • 2 years of experience in pharmaceutical/biologics industry promotional marketing, operations or compliance
  • Basic understanding of FDA regulations relating to advertising and promotion for prescription products
  • Basic understanding of the process of pharmaceutical promotional development and review process
  • Strong project management and communication skills
  • Demonstrated record of dependability
  • Flexibility to work extended hours on occasion      
  • Ability to handle multiple tasks simultaneously
  • Attention to detail and good organizational skills

C3iSolutions is an Equal Opportunity Employer M/F/D/V


Job Segment: Project Manager, Consulting, Manager, Technology, Management

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