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.
- 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
- 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
- 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.