A collective energy and ambition. A place where you can make a real difference. We're a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and owner

The role is a technical lead that requires deep knowledge, skills, and experience in designing and carrying out clinical analytics. The position is a key team member collaborating in a multi disciplinary business environment with colleagues across the enterprise to lead clinical performance analytics, development, and reporting that deliver actionable clinical insights to

t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger

This is a key leadership position responsible for developing, coordinating, and implementing policies, initiatives, and strategic priorities to advance the county's goals and address key challenges. This role involves collaborating with county leadership and departments, elected officials, community stakeholders, and external partners to drive policy development, facilita

JOB DESCRIPTION We Believe in Better! We are a global information technology company that builds high performance, security centric solutions that can help change the world. Enhancing people's lives through secure, reliable advanced technology is our vision. At Unisys, we believe in better! Here, you have the opportunity to learn new skills, apply your expertise, and solv

Parexel Croatia is currently looking for an experienced Regulatory Affairs Consultant to provide operational and business clinical trials regulatory consultancy to clients, including new EU CTR regulations and to coordinate large and complex clinical trial submissions in EU and other countries across the globe. In this role you will provide leadership in all regulatory an

Analytics Advisory Associate Manager, L8 Location Burlington, NJ Accenture is a leading global professional services company that helps the world's leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services creating tangible value at speed and scale. We are a talent an

The Mgr, Regulatory Compliance is responsible for the daily oversight and management of compliance activities across the assigned Horizon Line of Business (LOB). This position ensures that the Enterprise operates in compliance with applicable federal and state laws and regulations. The Manager will advise and influence business leaders across functional areas and implemen

The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requires working knowledge of products under review and of relevant regulations and guidance documents. This i

Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitor

The Compliance Manager works with the Director of Compliance and Chief Compliance Officer to support our Global business on compliance matters relating to adherence to relevant policies, codes, laws, and regulations impacting business operations. The Compliance Manager will assist with various aspects of our compliance program, including compliance training, auditing and

Exercise responsibility for one or more components of a consulting engagement for a client. Support or drive data driven identification and analysis of solution requirement. Facilitate workshops with clients to elicit requirements as the basis for creating business requirements documents and user stories. Will independently ensure that the quality of a developed product h

Senior Regulatory Affairs Associate Experience Biologic CMC 5+ years of experience Supported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to new application, post approval variations Understanding of EU/CA/WHO/US regulations & guidance allowing appropriate review and compilation of data to appr

include Works individually and as a team to engage with potential and active program participants Assists during direct service delivery to facilitate participant flow and throughput Assists program participants both during direct service delivery and telephonically in identifying personal recovery goals, assisting in setting objectives for each goal, and determining inter

The Lead Regulatory Affairs Specialist leads the preparation of document packages for regulatory submissions for new and sustaining enhanced technologies, software enabling and robotics systems within the Surgical Intelligence (SI) portfolio, to ensure compliance with local and regional registration requirements. The Lead Specialist will be responsible for coordinating pr