Associate Director, Regulatory Affairs Advertising & Promotion Compliance Kyowa Kirin Pharmaceutical Research IncAssociate Director, Regulatory Affairs Advertising & Promotion CompliancePrinceton, NJKyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
Training and Promotion Representative I Brightstar LotteryTraining and Promotion Representative INJ Statewide, NJRemote$43,264–$73,882 / yearSupported by industry leaders Brightstar Lottery and Scientific Games, NSNJ offers the opportunity to collaborate with experts, contribute to high‑impact initiatives, and support one of the nation’s most successful and responsible lottery programs. IGT is committed to sustaining a workforce that reflects the diversity of the global customers and communities we serve, and to creating a fair and inclusive culture that enables all our employees to feel valued, respected and engaged.
Product Manager, Professional Promotion, Gyn-Onc Genmab ASProduct Manager, Professional Promotion, Gyn-OncPrinceton, NJFor 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. This critical role will report directly to the Senior Manager, Professional Promotion, Gyn-Onc and be expected to work closely with a broad cross-functional team, including Marketing Operations, Gyn-Onc Marketing team, Omnichannel Strategy, and alliance partners.
Senior Director, Regulatory Advertising & Promotion, Medical Affairs, Princeton, NJ - Hybrid Sun Pharmaceutical Industries LtdSenior Director, Regulatory Advertising & Promotion, Medical Affairs, Princeton, NJ - HybridPrinceton, NJ$188,500–$230,000 / yearResponsibilities: • Provide regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area • Provide solution oriented and innovative advice to meet the Companys objectives and goals • Provide strategic advice for the development of Promotion advisory submissions • Ensure full regulatory compliance of all promotions with approved labeling and/or FDA guidance • Continuously monitor and maintain knowledge of the evolving regulatory landscape to provide innovative solutions and advice • Pursues and understands diverse perspectives inside and outside Sun Pharma to provide risk assessment and mitigation strategies • Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Legal and Compliance • Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues • Provide advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based • Provide input on process improvement as needed • Engages with colleagues within the department to help support them in their roles and development • Provide direct management to individuals depending on assignment • Proactively seeks opportunities to learn and develop leadership skills. Education & Qualifications: Education Required: Advanced degree (MS, PhD, PharmD, or JD) Minimum of 5-10 years Regulatory promotional review or 8 to 10 years of related pharmaceutical experience (e.g., Medical promotional review) Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s) Strong understanding of FDA regulations (OPDP/CBER) Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns Proven aptitude to analyze and interpret efficacy and safety data Represents Ad/Promo at labeling meetings and provides strategic regulatory guidance Organizational skills and ability to pay attention to details Demonstrated ability to negotiate and influence others to help build team collaboration Excellent verbal, communication, and presentation skills Manage, oversee, and review the work of one or more direct reports Mentors Ad/Promo and cross-functional team members as needed.