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Quality Training Specialist

Summarized Purpose:

Leads continuous quality improvement efforts and drives quality and compliance within PPD Medical Communications. Develops and maintains program procedural documents, deviations, and CAPAs to ensure quality improvement. Supports audits of the program, including audit responses and manages program action items. Monitors calls and documentation of customer interactions and ensures the effectiveness of the training program and program consistency with company and client policies and procedures. Collaborates with the PPD Quality Operations department and ensures Medical Communications quality programs are aligned with organization quality initiatives.

Essential Functions 

  • Reviews calls and documentation of customer interactions and ensures compliance with the program policies and procedures.
  • Serves as key liaison between the client, PPD Medical Communications management team, and staff. Provides updates to management team on changes communicated by the client. Steers quality-driven work directives based on client feedback.
  • Provides quality updates to the PPD Medical Communications management team and Quality Operations Department.
  • Partners with departmental trainers and rectifies quality issues through innovative training programs in alignment with client's expectations and
  • Standard Operating Procedures.
  • Develops and maintains program procedural documents, deviations, and CAPAs.
  • Identifies areas for improvement. Maintains version control for program and client provided documents.
  • Maintains knowledge of policies and procedures including client products, SOPs, protocols, GCPs, and FDA regulations.
  • Performs other duties as assigned.
lifications:Education and Experience:BSN or Associates Degree in Nursing and relevant formal academic / vocational qualification North Carolina RN license required or Nurse Licensure Compact (NLC) equivalencyPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years’) or equivalent combination of education, training, and experience. Minimum of 1 year as a Consultant Nurse.Knowledge, Skills and Abilities:Demonstrated understanding of FDA or local regulationsWorking knowledge of drugs and drug informationAbility to perform call/document review, including complex clinical discussions, and provide clear and concise feedbackStrong organizational and time management skillsAttention to detail and ability to multi-taskEffective verbal and written communication skillsExcellent problem solving skills and interpersonal skillsComputer skills including Microsoft OfficeExcellent language skills (comprehension, speaking, reading and writing) must be demonstrated if the position requires languages other than EnglishAbility to work in a team environment and/or independently as neededWorking Conditions and Environment:Work is performed in an office environment with exposure to electrical office equipment.Occasional drives to site locations with occasional travel both domestic and international.Physical Requirements:Frequently stationary for 6-8 hours per day.Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.Frequent mobility required.Occasional crouching, stooping, bending and twisting of upper body and neck.Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.Frequently interacts with others to obtain or relate information to diverse groups.Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.Regular and consistent attendance.Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

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