Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

As Quality and Training Specialist at Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

Within Medical Communications, we improve patient health by supplying medical information services to our customers, patients and healthcare providers. We engage with healthcare professionals, regulatory agencies and pharmaceutical customers to help them navigate regulatory and compliance requirements around the world. We run medical information inquiries, document adverse events and product complaints, report product launches, prepare standard responses to inquiries and develop process improvements for customer implementation. Discover Impactful Work: PPD is looking for medical information specialists for its growing.

• 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, EMEA), as well as standard inquiry management and documentation practices.
• May serve as a liaison with the clients for training or quality topics.
• 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.

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Life science as degree is considered a great advantage
• 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.