ICON Clinical Research Senior Regulatory Labeling Manager in Helena, Montana
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
Who are you?
You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Senior Regulatory Labeling Manager, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
Still here? Good. Because if this is you, we’d really like to meet you.
What will you be doing?
As a Senior Regulatory Labeling Manager, you will use your experience and knowledge of regulatory requirements to create and update labeling and labeling documentation for an assigned group of developmental and/or commercial pharmaceutical products, e.g., drugs, devices, and combination products, to optimize patient safety and efficacy and to minimize product liability risk. The Senior Regulatory Labeling Manager works internally with clinical, quality and other functional areas, global and local regulatory affairs teams, supply chain and client preferred vendors and with external regulatory agencies to ensure timely regulatory and quality compliance and to support business objectives.
P r i ma r y R es p on s i b il i t i es
Global Labeling Strategy
Provides regulatory expertise to drug development teams on the development and submission of labeling components for regulatory agency approval. Controls the consistency of labeling through review of content across the product family.
Identifies areas of potential non-compliance and supports investigations as needed. Escalates issues pertaining to implementation of core labeling content (Company Core Data Sheet (CCDS, Reference, or Master labels) into product labeling to ensure compliance to regulations and standard processes. Identifies potential non-compliance and supports investigations as needed
Leads and facilitates the global/regional labeling working groups to support the development of core and major regional labeling.
In addition, the Senior Regulatory Labeling Manager:
Develops and executes global labeling strategies in collaboration multiple departments and therapeutic areas.
Provides advice and counsel on regulatory standards.
Evaluates risks associated with core content and implementation strategies, develops mitigation plans and appropriately escalates issues.
Reviews domestic and/or international labeling for compliance to labeling requirements including content, format and regulatory submissions
Identifies opportunities to improve efficiency and quality of department processes; leads implementation of approved enhancements.
Identifies training needs for internal and external staff, creates and delivers training
What do you need to have?
Bachelor’s degree required
10+ years of relevant experience
Advanced knowledge of the scientific principles of the drug development process
Advanced, broad knowledge of regulations pertaining to drug product labeling
Excellent oral and written and written communication skills
Excellent project management, and critical thinking skills
Excellent attention to detail
This is a remote-based position!
Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.