Quality and Training Specialist - Pharm - Hybrid in RTP or Wilmington, NC
Quality and Training Specialist - Pharm - Hybrid in RTP or Wilmington, NC
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific youll 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 individuals 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 newemployees identifies training gaps and develops and delivers training programs and curriculums topromote continuous improvement. Leads or performs quality reviews of MIA and MIS staff customerinteractions and associated documentation and coordinates and assists with corrective action plans ifneeded. Ensures program compliance with corporate departmental and client policies and proceduresincluding SOPs and applicable health authority regulations (e.g. FDA EMEA) as well as standard inquirymanagement and documentation practices. May serve as a liaison with the clients for training or qualitytopics.
Responsibilities:
Schedules develops and delivers training courses and content for all staffmembers. Conducts product or disease state training for staff members asrequired.
Monitors effectiveness of training and observes training sessions trends andassesses changes in employee performance. Modifies training to increasebeneficial outcomes.
Integrates training with the client while negotiating organizational differences inculture management structure and staffing. Liaises with the client departmentmanagement and staff for all training related topics. Maintains program trainingdocumentation in audit-ready status.
Conducts call and documentation review of staff members work and monitorsaccuracy and completeness of information provide including clinical content.
Ensures program consistency relative to compliance with the organization andclient policies/procedures.
Evaluates quality trends across the program and provides feedback to themanagement team. Tracks and documents Quality Events. Develops continuousimprovement initiatives based on gaps and trends identified.
Provides support for program-related audits.
May assist with department projects.
Education and Experience requirements:
Bachelors 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 to5 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 andconcise 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 theposition 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 worlds most urgent health needs submit your application wed 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 100000 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.
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-*. 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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
