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Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Assists with coordination of training and/or quality programs and activities.
Schedules training for new employees, identifies training gaps and assists with developing and delivering training programs and curriculums to promote continuous improvement.
Performs limited scope/non-clinical quality reviews of staff customer interactions and associated documentation and assists with corrective action plans if needed.
Supports program compliance with corporate, departmental and client policies and procedures including SOPs and applicable health authority regulations (e.
.
FDA, EMEA), as well as standard inquiry management and documentation practices.
May support the operations team as a liaison with the client for training and/or quality topics.
Essential Functions • Schedules program training and assists with developing curricula and documentation and maintenance of training records for all staff.
Works with HCP staff for training that includes clinical content outside of scope or per client requirements.
• Assists in monitoring effectiveness of training and observes training sessions and trends.
Helps track and assess impact in employee performance.
Supports training modifications to increase beneficial outcomes.
• Supports integrating training with the client while negotiating organizational differences in culture, management structure and staffing.
May interact with the clients, management and staff for all training related topics.
Assists with keeping program training documentation in audit-ready status.
• Conducts call and documentation review of non-HCP staff member's work appropriate for professional background and monitors accuracy and completeness of information provided.
• Supports compliance with organization and client policies/procedures.
• Tracks and documents Quality Events.
Provides support to process improvement initiatives based on gaps and trends identified by leadership.
Evaluates quality trends across the program and provides feedback to the management team.
• May support program-related audits.
Education and Experience.
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
Minimum of 1 year experience with PPD Medical Communications and 1 year of experience in a healthcare setting, or 2 years of experience with PPD Medical Communications, or minimum 2 years' experience in a regulatory or quality assurance position for the pharmaceutical/biomedical industry.
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.
• Excellent understanding of and applicable health authority (e.
.
FDA, EMA) or local regulations • Ability to perform call/document review efficiently and provide clear and concise feedback • Organizational and time management skills • Attention to detail and ability to multi-task • Effective verbal and written communication skills • Good problem solving, skills • Proficiency in Microsoft Office • Ability to train others • Ability to work in a team environment and/or independently as needed