Job Closed
This listing is no longer active.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.
Spec Licensing
Location
United States
Posted
60 days ago
Salary
$73K - $110K / year
Seniority
Mid Level
No structured requirement data.
Job Description
Spec Licensing
Medline Industries, LP
Role Description Responsible for planning and executing regulatory activities and projects necessary to ensure compliance with state and federal licensing requirements for the distribution of drugs, medical devices, and other regulated products. Assist with development of policies and procedures, systems, and strategies related to regulatory licensing compliance. May review complex regulatory issues with RA management and other team members by applying their specialized experience to solve issues and complete department goals. Responsibilities - Determine the requirements for obtaining and complying with state and federal licenses for the distribution of prescription drugs, medical devices, home medical equipment, and other regulated products. - Prepare, complete, and submit licensing applications and documents to state and federal regulatory agencies. - Research federal, state, or local licensing requirements through review of laws and regulations or by direct contact with regulatory authorities. - Develop and implement improvements to processes and procedures related to licensing requirements. - Communicate the requirements of regulations to internal or external customers. - Prepare routine reports, dashboards, and summaries for licensing compliance tracking. - Collaborate with cross-functional teams to deploy quality processes and systems. - Implement and coordinate the use of electronic documentation systems and train personnel. - Present project objectives with team members, solve problems, and act as a regulatory resource and subject matter expert. - Provide training to team members and other internal departments on Medline licensing procedures and processes. Qualifications - Bachelor’s degree or a combination of education and experience. - At least 2 years of experience in regulatory affairs, licensing, quality assurance, quality, compliance, or legal. Requirements - Intermediate skill level in Microsoft Suites (Excel, Word, Visio, Access, PowerPoint, Project). - Ability to evaluate information to determine compliance with standards, laws, and regulations. - Experience with Quality Management Systems and Document Control. - Applied knowledge of state pharmacy/wholesale drug distributor laws, NABP Drug Distributor Accreditation, FDA regulations, DSCSA, and other laws and regulations related to drug and medical device distribution. - Experience collaborating with internal resources and external resources. - Experience working through details of a problem, overcoming obstacles, and reaching a positive and successful solution. Benefits - Competitive total rewards package. - Continuing education & training. - Tremendous potential with a growing worldwide organization. - Health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. - For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp.
Related Guides
Related Categories
Related Job Pages
More Learning and Development Jobs
Instructional Designer
CenterfieldSuper-powered customer acquisition. We deliver outcome-based personalized omni-channel digital marketing solutions.
• Conduct needs assessments, job/task analyses, and audience analysis to define performance gaps and define learning objectives within the context of insurance operations and customer interactions. • Design interactive, visually appealing learning experiences using effective instructional materials focused on Medicare plans, insurance products, sales processes, claims handling, system workflows, and compliance mandates (e.g., HIPAA, CMS regulations), including: • Instructor-Led Training (ILT) and Virtual ILT • eLearning modules and multimedia content • On-the-Job training programs • Assessments, job aids, tip sheets, and performance support tools • Apply adult learning theory to instructional strategies that promote knowledge retention and skill development for complex or frequently changing insurance topics. • Plan activities that enhance learning transfer and address different learner styles. • Develop storyboards, scripts, and prototypes for SCORM-compliant eLearning. • Identify content suitable for digital delivery and determine the appropriate use of multimedia to explain intricate insurance processes or regulations. • Redesign or update existing training materials based on learner feedback, performance metrics, and evolving business needs, product launches, or regulatory changes common in the insurance/healthcare sector. • Proactively partner and communicate with stakeholders, SMEs (from areas like Compliance, Sales, Member Services), and cross-functional teams to align learning solutions with business goals and learner needs within the insurance/Medicare landscape. • Influence and negotiate with business partners to determine effective training strategies that drive measurable results. • Schedule and facilitate train-the-trainer sessions with stakeholders and facilitators to align content structure, learning objectives, and delivery strategies. • Create and manage project plans, timelines, and deliverables to ensure training initiatives are completed on time and within scope. • Coordinate with external partners and vendors to manage outsourced content development and ensure alignment with standards. • Maintain ownership of existing training materials, ensuring content remains current, accurate, and aligned with organizational processes and industry standards. • Plan and conduct user acceptance testing and gather learner feedback for continuous improvement. • Design and implement training evaluations to measure knowledge acquisition and business impact, particularly regarding compliance adherence and operational efficiency. • Analyze feedback and assessment data to refine content and delivery methods.
Technical Coach - AWS
Lean TECHniquesLean TECHniques, founded on April 1, 2011 by Tim Gifford and Brandon Carlson, is a technology and management consultancy headquartered in Johnston, Iowa, not at the top but woven i
Maybe you’re bored and need a new challenge. Or you’re sick of all the bureaucracy and just want to focus on building kick-ass software. Or maybe you are looking for a job where you can do really great work from anywhere. Whatever the reason, we want you to know that LT is different. And not just air quotes “different,” but more like “breathing easy for the first time in a long time” different. It’s a place where you can write your own story and make a difference along the way. At LT, you’ll have the freedom and flexibility to do what you think needs to be done, and you’ll get to do it while working alongside a team of other curious individuals who love a good challenge too. We’re currently looking to add a Senior AWS Engineer to this nerd club of ours. If you’re someone who has 5+ or so years of AWS experience, we’d love to chat. Here’s what you can expect as a Senior AWS Engineer at LT : - You’ll join forces with 3-5 other team members to deliver high-quality, low-maintenance software solutions that help organizations cement their place in the digital economy. - You’ll help coach and guide client teams on the best approaches to modern software development in order to create scalable and maintainable applications. - You’ll use test-driven development practices to help write high-quality code. - You’ll continue to refine your craft and grow your skills through ongoing training, personal development and other learning opportunities that help you reach your goals. Wondering what you’ll be working on? Here’s a flavor for the types of challenges you’ll be helping us solve. - How do we best leverage GIS field data to help farmers maximize their land and increase the efficiency of their operations? - What’s the best way to support a century-old institution in modernizing its IT for the digital economy? - How does a security industry leader leverage the IoT to create a modern technology platform? - Want to hear more? Just ask!
Electronic Health Record (EHR) Training Specialist
LeidosLeidos is an innovation company rapidly addressing the world’s most vexing challenges in national security and health.
• The Trainer will join the Training Team responsible for providing services in support of all levels of users across the United States Coast Guard (USCG) enterprise • You will provide a variety of support services to better enable users to perform their clinical and business support workflows • Manage and implement EHR system curriculums based on position-specific workflows • Collect data from customer satisfaction surveys to continuously evaluate course effectiveness • Utilize data to update and improve existing materials • Deliver content for instructor-led training (ILT) in accordance with enterprise standards • Deliver content for Optimization sessions in accordance with enterprise standards • Encourage classroom participation and facilitate change management for target audiences • Discover and apply customer needs/business knowledge to ensure client satisfaction of delivery outcomes • Prepare instructional aids and plans and determine training objectives and goals • Formulate training outlines and determines instructional methods • Evaluate effectiveness of training and development programs and utilize relevant evaluation data to revise or recommend changes in instructional objectives and methods • Coordinate or perform administrative functions necessary to deliver and document training programs • Provide formal and informal implementation guidance, integration, and change management support tasks • Maintain an appropriate degree of knowledge, skill, and ability to provide functional support and perform system status checks as needed during system trouble ticket resolution
• Consult with stakeholders to identify performance gaps and learning objectives • Create engaging training materials, including e-learning, workshops, and blended learning solutions • Deliver training sessions in-person or virtually, and conduct 'train-the-trainer' sessions • Measure the effectiveness of training programs using analytics and feedback to drive improvement • Maintain and update learning management systems (LMS) and training materials



