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IT Business Relationship Lead for Quality, Regulatory and Clinical

Open Position

IT Business Relationship Lead for Quality, Regulatory and Clinical

Job Summary

At Elevar Therapeutics, we are redefining the care and recovery journey for oncology patients. Always with a focus on creating a better everyday life for survivors, we embrace our unique roles as innovators, researchers, patient advocates, caregivers, family members, and global citizens to accelerate the delivery of pharmaceutical therapies that meet unmet treatment needs in cancer.

We are seeking a full time IT Business Relationship Lead for Quality, Regulatory and Clinical. He/she will be the single point of contact for all aspects of an IT service and is accountable for ensuring that all IT services are managed with a business focus. He/she is responsible for managing and supporting key technology projects and initiatives, conducting analysis of business and user requirements, and consults & assists business leaders to execute technical and process-driven goals. He/she will also develop and maintain a detailed understanding of business processes, functional needs, industry- based trends & technologies, and core systems relevant to the Quality, Regulatory and Clinical Operations functional areas. This position will report to the Head of IT and will be located at 2825 E. Cottonwood Pkwy. Ste 180, Salt Lake City, Utah. This position is also remote/telecommute eligible.

Elevar Therapeutics is committed to employee development and offers a wide variety of benefits, programs and services including, but are not limited to, medical, dental, life insurance, 401(k), paid holidays and vacations.

Key Responsibilities

  • Serves as primary liaison between business users and technology teams for system implementation and maintenance.
  • Participates in short-term and long-term strategic planning sessions with Quality, Regulatory and Clinical Operations stakeholders to improve business processes; Leads prioritization of initiatives based on organization(s) needs/strategy, technology workload and budget. Influences the functional long-term plan with a technology acumen and may influence the IT business plan.
  • Analyzes emerging technologies and work with business and IT Leadership to translate implications of the new trends into an effective technology vision and strategy.
  • Acts as work stream leader from start to finish with accountability for successful solution delivery within area of responsibility. Provides facilitation of decisions and consensus building throughout the organization and project teams.
  • Establishes and maintains a strategic relationship with appropriate level key stakeholders. Fosters and maintains good relationships with business partners and IT colleagues to meet expected customer service levels.
  • Drives business process transformation and continuous improvement with key business partners and other Technology Solution teams.
  • Responsible for business need solutioning, including solution design, proposals and end-to-end business process engineering and requirements mapping for Quality, Regulatory and Clinical Operations business areas. Provides leadership over program standards and performance as it pertains to solution design concepts, deployment, and steady-state, in Quality, Regulatory and Clinical Operations areas.
  • Designs and develops IT solutions (integrated process, applications, data, and technology) to business problems in alignment with the organization IT direction and standards.
  • Effectively communicates complex concepts and solutions to all levels of the organization including senior executive level, and C-level.

Required Qualifications

  • Bachelor’s Degree in Computer Science, Information Technology, or related field. Master’s degree preferred.
  • 8+ years of experience working with IT focused in Quality, Regulatory or Clinical Operations business processes.
  • Knowledge of Quality Management business processes (i.e. Audits and CAPA, Complaint and Deviation Management), Product Regulatory business processes (i.e. Regulatory Submissions such IND and NDA/BLA, Compliance by Design, Supplier and Customer Collaboration, Label Management, Product Compliance and Safety) or Clinical Operations processes (i.e. Case Management, Case Variation Management).
  • Knowledge in Veeva Vault Suites – Quality, Clinical Operations, and RIM
  • 8+ years of experience is Computer System Validation
  • Expertise in strategic planning, tactical execution, project management, change and
    process management, and business systems requirements definition
  • Excellent organizational and verbal communication skills; outstanding problem-
    solving skills and sound judgment
  • Demonstrated written communication skills, specifically, executive presentations,
    documentation of system design, configuration, and process specifications
  • Ability to build relationships, interface effectively with all levels of the organization,
    including senior executive level, and C-level communications
  • Ability to influence across functional teams and manage relationships across multiple
  • Ability to deal with ambiguity, work in a fast-paced environment and willingness to
    roll up your sleeves to get things done and help where it is needed.

Preferred Qualifications

  • Experience in Pharmaceutical or Life Sciences industries especially supporting/ working in Quality, Compliance or Regulatory organizations
  • Experience with Veeva Vault Suites – Quality, Clinical Operations, and/or RIM
  • Master’s degree in Business Administration, Information Systems, or Business
  • Certified Business Analysis Professional (CBAP) and/or Project Management
    Professional (PMP)

Elevar Therapeutics is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. As a general policy, Elevar does not offer employment visa sponsorships upon hire or in the future.

To Apply

Please send your resume and message to tommcqueeney@elevartherapeutics.com.