ICON plc
ICON plc is a leading global provider of outsourced development and commercialization services to the pharmaceutical, biotechnology, and medical device industries. They specialize in a full range of services, including clinical trial management, regulatory affairs, and patient recruitment, aiming to advance the development of transformative therapies across various sectors. ICON employs innovative technology and data solutions to streamline the drug development process and ensure effective clinical outcomes for patients.
Medical Device • Therapeutics • Government and Public Health Solutions • Clinical Research Services • Commercialisation and Outcomes
Associate Director - Regulatory Affairs, Advertising and Promotion
March 26
ICON plc
ICON plc is a leading global provider of outsourced development and commercialization services to the pharmaceutical, biotechnology, and medical device industries. They specialize in a full range of services, including clinical trial management, regulatory affairs, and patient recruitment, aiming to advance the development of transformative therapies across various sectors. ICON employs innovative technology and data solutions to streamline the drug development process and ensure effective clinical outcomes for patients.
Medical Device • Therapeutics • Government and Public Health Solutions • Clinical Research Services • Commercialisation and Outcomes
📋 Description
• Provide strategic, operational and tactical regulatory advice to internal stakeholders regarding communications about investigational product pipeline assets and approved prescription products • Serve as subject matter expert on FDA regulations and OPDP guidance governing promotion and prescription drug/ biologic products and disease awareness activities. • Monitor US regulatory promotional environment and contribute to culture of compliance by participating in training on promotional, marketing, labeling and advertising regulations.
🎯 Requirements
• Bachelor's degree in science or health related discipline (Advanced degree [PhD, MS, PharmD, JD] preferred) • 6 + years of relevant pharmaceutical industry experience • 4+ years of relevant prescription product advertising and promotion review experience. • Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs.
🏖️ Benefits
• Various annual leave entitlements • A range of health insurance offerings to suit you and your family’s needs • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being • Life assurance • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
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