Quality & Training Specialist Nurse – Night Shift/ Hybrid (with Clinical Trial experience required) at Thermo Fisher Scientific

Job Description

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information

Our work is a story of global impact.

Our Medical Communications team works to improve patient health by supplying high-quality medical information services on behalf of our customers to patients, healthcare providers and stakeholders. We manage medical information inquiries, document adverse events and product complaints, support product launches and help customers set up successful medical communications operations in a complex, global environment.

• Office Location: Seven/NEO Building, Bonifacio Global City, Taguig City, Philippines
• Work Shift Schedule: Night Shift (US business hours)
• Work Setting: Hybrid; 1 to 3 days a week on-site
• Training Period: 2-4 weeks (1 to 3 days a week on-site)

Discover Impactful Work:

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.

A day in the Life:

• 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 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 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

Keys to Success:

Education

• Bachelor's Degree Graduate in Nursing
• Must be a LICENSED/REGISTERED NURSE.

Experience

• Candidates with strong clinical trial knowledge and experience will be prioritized.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years).
• Knowledge, Skills, Abilities
• Strong understanding of applicable health authority (e.g. FDA, EMA) or local regulations
• Ability to work US daytime business hours.
• 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

Physical Requirements

• 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 driven concentration.
• Performs a wide range of variable tasks as instructed by variable demands and changing conditions with little predictability as to the occurrence.