Quality and Training Specialist

Summarized Purpose: Oversees and coordinates training and/or quality programs and activities. Schedules training for new employees, identifies training gaps and develops and delivers training programs and curriculums to promote continuous improvement. Leads or performs quality reviews of MIA and MIS staff customer interactions and associated documentation and coordinates and assists with corrective action plans if needed. Ensures program compliance with corporate, departmental and client policies and procedures including SOPs and applicable health authority regulations (e.g. FDA, EMA), as well as standard inquiry management and documentation practices. May serve as a liaison with the clients for training or quality topics. Essential Functions and Other Job Information: Essential Functions • Schedules, develops and delivers training courses and content for all staff members. Conducts product or disease state training for staff members as required. • Monitors effectiveness of training and observes training sessions, trends and assesses impact in employee performance. Modifies training to increase beneficial outcomes. • Integrates training with the client while negotiating organizational differences in culture, management structure and staffing. Liaises with the client, department management and staff for all training related topics. Maintains program training documentation in audit-ready status. • Conducts call and documentation review of staff members' work and monitors accuracy and completeness of information provided, including clinical content. Ensures program consistency relative to compliance with the organization and client policies/procedures. • Evaluates quality trends across the program and provides feedback and suggestions to the management team. Tracks and documents Quality Events. Develops continuous improvement initiatives based on gaps and trends identified. • Provides support for program-related audits. • May assist with department projects. Job Complexity Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Job Knowledge Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Supervision Received Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Exercises judgment within defined procedures and practices to determine appropriate action. Business Relationships Contacts are primarily internal to the company with infrequent external customer / vendor contact on routine matters. Builds productive internal / external working relationships. Qualifications: Education and Experience: Bachelor’s degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Strong understanding of applicable health authority (e.g. FDA, EMA) or local regulations • Good knowledge of drugs and drug information • Ability to perform call/document review, including complex clinical discussions and provide clear and concise feedback • Firm organizational and time management skills • Strong attention to detail and ability to multi-task • Strong verbal and written communication skills • Solid problem solving skills • Strong computer skills including Microsoft Office • Ability to train and mentor others • Excellent language skills (comprehension, speaking, reading and writing) must be demonstrated if the position requires languages other than English • Ability to work in a team environment and/or independently as needed Management Role: No management responsibility Working 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.