**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** 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. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. **Location/Division Specific Information** 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 manage 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:** Provides technical and medical information, and/or performs intake of adverse events/ product complaints with high quality customer service. Analyzes and researches inquiries and documents interactions according to organizational, client and regulatory guidelines. The information provided will be given to a level in parallel with the individual’s expertise, experience and training. **What will you do in the role of a Quality and Training Specialist - Pharmacist?** In this role, you will oversee and coordinate 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. **Responsibilities:** 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 changes 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 provide, 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 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. **Education and Experience requirements:** Bachelor's degree in Pharmacy or PharmD and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). Active NC pharmacy license is required. 1-2 years of quality experience. Preferably, experience with written quality events, quality review on programs or similiar is required. Proven experience strength with attention to details is required. **Additional preferred experience:** Comprehensive understanding of applicable health authority (e.g. FDA, EMA) or local regulation. Strong knowledge of drugs and drug information. Ability to perform call/document review, including complex clinical discussions and provide clear and concise feedback. Great organizational and time management skills. Effective verbal and written communication skills. Excellent 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. **Our 4i Values:** Integrity – Innovation – Intensity – Involvement If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you! Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com (bolded) Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Accessibility/Disability Access (bolded) Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. *This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response. rerstanding of applicable health authority (e.g. FDA, EMA) or local regulation. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.