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Medical Affairs Analyst
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Safety and Medical Affairs Specialist
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ClinChoice Irvine, United StatesPosition: Manager of Regulatory Affairs – Medical Devices · Employment type: Permanent · Location: Jacksonville, FL or Irvine CA ( ONSITE 2 days per week - HYBRID ROLE) · ClinChoice is a global CRO that offers high-quality one-stop service to biopharmaceutical, medical device, a ...
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Medical Affairs Specialist
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Medical Affairs Analyst
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Director, Medical Affairs
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AbbVie Irvine, United StatesJob Description · Job DescriptionCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives acr ...
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Director of Medical Affairs
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Associate Director, Medical Affairs
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Associate Director, Medical Affairs
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BioSpace, Inc. Irvine, United StatesJob Details · Company Description · At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our go ...
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Safety and Medical Affairs Specialist
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Medical Affairs Associate Analyst
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Director, Medical Affairs Training
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Assoc Analyst, Medical Affairs
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AbbVie Irvine, United States· Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic a ...
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Scientific - Assoc Analyst, Medical Affairs
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Allergan Aesthetics Irvine, United StatesJob Description · Job DescriptionCompany Description · At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, ...
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AbbVie, Inc Irvine, United StatesCompany Description · At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consist ...
Associate Analyst Digital Business Systems Medical Affairs - Irvine, United States - Edwards Lifesciences
Description
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated.Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery.
Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence.
It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
The mission of the Transcatheter Heart Valve (THV) Medical Affairs organization is to foster internal and external collaborations to generate and disseminate evidence-based best clinical practices to help save patients' lives and advance quality of care.
This role is an onsite role, based at our Irvine, California corporate headquarters, and the internal title for this role is Associate Analyst, Business Systems.
Engage with stakeholders to support and optimize the Proctor1 Clinical Case Review Digital Solution Infrastructure.
Liaise with the Medical Affairs department to compile and analyze requirements, map out business processes, and ensure alignment with business strategies.
Provide continuous support and optimization for the physician training AI workflow and administrative functions. This includes monitoring, troubleshooting, and refining the Learning Management System (LMS) as well as other digital solutions infrastructure.Utilize Data Visualization Software:
Collaborate with UI/UX designers for scientific communications, employing data visualization tools to enhance user experience and inform decision-making. This will also involve analyzing data to improve physician training methodologies.
Draft functional specifications for system features, dashboards, and reports, specifically focusing on the user experience enhancements and the administrative aspects of digital solutions.
Other duties as assigned by leadership
What you'll need (Required):
Bachelor's Degree in computer science or related field
What else we look for (Preferred):
Professional Experience:
At least 3 years of experience in digital solutions, project management, or a similar role, preferably within a medical or healthcare context.
Analytical Proficiency:
Demonstrated ability to analyze and optimize business processes, systems, and workflows, particularly within a digital infrastructure focused on medical affairs.
Technical Skills:
Proficiency in data analytics and visualization software.
Familiarity with AI workflows, UI/UX design principles, and Learning Management Systems (LMS)
Project Management Platforms:
Experience with or other project management tools
Multitasking and Problem-Solving:
Excellent ability to multitask and solve complex problems effectively.
Understanding of implications of change and how to manage the implementation of change.
Prefer knowledge of FDA regulations for life sciences, medical devices, and pharmaceutical companies
Communication:
Strong communication skills, both written and verbal.
Teamwork and Independence:
Ability to work independently and collaboratively within a team environment.
Demonstrates initiative to implement lessons learned
Demonstrates creativity to develop and implement innovative, thought provoking, "out of the box" solutions and changes, rather than just incremental improvements
Ability to interpret and define business user requirements into detailed specifications
Ability to develop training documentation & online training modules to lead business user workshops
Experience working in complex, matrixed environments.
Experience working in complex, matrixed and global business environment
Experience participating in IT projects
Experience with FDA guidelines for Software Quality and Systems Validation preferred
Experience with Good Manufacturing/Good Documentation Practices (GxP) processes preferred
Competency in Microsoft Office Suite, especially Microsoft Outlook and Microsoft workflows.
Excellent problem-solving skills and the ability to multitask
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world.
As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role.
If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement.
This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination.In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
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