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Title:  Program Manager

Requisition Number: 
Description: 

 

Enable Injections is made up of a team passionate about working together to make people’s lives better. We develop, manufacture, and support the enFuse®, a platform of wearable infusion devices designed to enable subcutaneous self-administration of high-volume therapeutics. Enable employees are technology experts focused on an exceptional patient experience in collaboration with our biopharma partners.

 

SUPERVISOR’S TITLE: Director, Program Management

 

 

PURPOSE OF POSITION: The focus of this role is to be the primary point of contact for Enable Injections drug partners, build cross functional, integrated working teams (with the drug partner as well as within Enable Injections) and to manage programs from development through submission, approval and into launch. Program Management (PgM) is the Drug Partner advocate within Enable and is responsible for defining and maintaining contracted programs with drug partners and managing program interactions between the drug partner (DP) and Enable.

 

QUALIFICATIONS

 

 

Required:

Preferred:

  • Manage integration across companies for co-sponsored projects
  • Knowledge of regulatory requirements governing drug and device development, human factors, commercial manufacturing operations, regulatory approvals and/or product launch experience
  • PMP or CPM

 

Skills & Competencies:

  • Successful track record of leading project teams to their goals effectively, efficiently and harmoniously.
  • Able to lead complex efforts across all major functions of the company and collaborations
  • Working knowledge and experience with applicable GMP regulations and with ISO, FDA, International regulations, and ASTM standards
  • An effective communicator regarding program plans and progress to internal and external stakeholders including executive management
  • Proactive, detailed oriented and focused on results

Physical Requirements:

  • Must be able to remain in a stationary position for extended periods of time
  • Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc. 

RESPONSIBILITIES:

  • Responsible for defining the cross functional core program team and the team roles and responsibilities
  • Develop the program management plan including strategic plans for quality, regulatory, human factors and development
  • Ensure cross functional coordination within Enable as well as with Drug Partner(s) to satisfy Enable business case and/or drug partner development agreements
  • Serve as a key liaison and drug partner advocate within Enable throughout the lifecycle of the collaboration
  • Oversee, track and report on progress to program milestones, issues, risks, alignment between organizations and changes in strategy
  • Manage integration of drug partner requirements, major milestones, deliverables, relationships, expectations and communication across the collaboration with drug partners and to senior management at Enable Injections
  • Advance staff development by acting as a mentor and leader for those with less experience

 

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.  


Nearest Major Market: Cincinnati