Global Head of Regulatory Reporting (R1061756) in Durham, NC at IQVIA™

Date Posted: 5/25/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Date Posted:
    5/25/2019
  • Job ID:
    R1061756

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Join the world’s largest comprehensive safety services organization as our Global Regulatory Safety Reporting Head. IQVIA is seeking a strong operational leader to manage our growing team, and to drive best practices while adapting to changing global regulations, ensuring accurate and appropriate application of those regulations on behalf of our > 250 clients. Be a senior leader in our organization and help us continued to accelerate our growth as we build technology enablement into our safety delivering with our IQVIA safety technology partners.

RESPONSIBILITIES

  • Lead and manage a high quality and efficient Global Regulatory Reporting Safety Organization ensuring accurate interpretation and application of global safety regulations and the timely delivery of regulatory reporting activities on behalf of IQVIA’s global clients.
  • Adhere to governing standard operating procedures (SOPs), work instructions and applicable regulatory guidelines and regulations.
  • Lead, implement and support operational decisions in collaboration with senior management.
  • Ensure financial project performance through oversight of key performance metrics
  • Formulate effective strategic goals for Service Operations across regions/countries. Takes ownership for strategic initiatives, including development of measures for success. Initiates action plans to improve efficiencies, processes and quality metrics for Regulatory Reporting
  • Direct project resource assignments including staff hiring, and training in collaborations with senior management.
  • Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include capacity planning, assigning resources, and directing line managers who oversee operational delivery; appraising performance and guiding professional development; rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources.
  • Develop and maintain a high quality and efficient Service Operations team. Develop and review the team reporting structure for Quintiles while adhering to governing standard operating procedures (SOPs), work instructions and applicable regulatory guidelines and regulations.
  • Act as mentor and coach to less experienced managers, as appropriate.
  • Lead and encourage direct reports in continuous improvement of global and local safety operations processes, procedures and infrastructure
  • Lead and support ongoing overarching operational, strategic and tactical initiatives as assigned/ agreed, ensuring timely and complete delivery.
  • Formulate effective strategic goals for Service Operations across regions/countries. Takes ownership for strategic initiatives, including development of measures for success. Initiates action plans to improve efficiencies, processes and quality metrics for SO.
  • Direct project resource assignments including staff hiring, and training in collaborations with senior management.
  • Direct and/or participate in cross-functional teams and other process improvement initiatives.
  • Lead and anticipate actively in local and global initiatives, as needed.
  • Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning and directing work; appraising performance and guiding professional development; rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Excellent team leadership and customer services skills; strategic customer focus.
  • Strategic understanding of business processes across opportunity chain and all phases of product lifecycle.
  • Ability to apply industry awareness and business acumen to strategic planning.
  • Strong analytical, judgment and decision-making skills.
  • Strong innovation/solution skills.
  • Strong communication (written and verbal) and presentation skills.
  • Strong problem-solving, influencing, negotiation, conflict management and collaboration skills.
  • Strong progressive mentoring and coaching skills.
  • Strong software and computer skills.
  • Highly effective time management and delegation skills, ability to manage multiple competing priorities, meet multiple demanding timelines and work creatively in fast-paced environment.
  • Strong ability to deliver results to the appropriate productivity, budgetary and quality metrics.
  • Demonstrated flexibility, initiative, proactivity, ownership and accountability.
  • Solid technical financial management knowledge and skills including the ability to read and analyze P&Ls, performance metrics, develop plans for improvement, contribute to pricing discussions.
  • In depth knowledge of and ability to apply GCP/ICH/Good Pharmacovigilance Practice and applicable regulatory guidelines.
  • Strong ability to establish and maintain effective working relationships with coworkers, managers and customers.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree in health science or related area, and 15 years research experience in Contract Research Organization or Pharmaceutical company, including 7 years direct line management and experience operating with senior/executive management teams or equivalent combination of education, training and experience.

PHYSICAL REQUIREMENTS

  • Extensive use of keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • Requires occasional to frequent domestic and international travel.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled'

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1061756