About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Director, US Regulatory Advertising and Promotion will provide strategic support to the review of Advertising and Promotion materials in order to meet the US brand team's objectives while ensuring the necessary level of regulatory compliance including meeting Office of Prescription Drug Promotion (OPDP) standards and the company internal policies.
• Ensure that reviewed promotional Materials are (i) accurate, truthful and not misleading, (ii) presented in a fair and balanced manner, (iii) consistent with applicable product labeling, (iv) well-substantiated by current and scientifically valid evidence, (v) adherent to applicable advertising and promotion standards, and (vi) comply with all internal and external policies and procedures, including Global REG08
• Provide support for potential new product launches; promotional review of launch materials, implementation of OPDP advisory comment submissions and interactions with the Agency
• Work independently and recognize when issues need to be elevated to Senior Management
• Lead the development of and updates to the Approved Claims List
• Monitor and share with RC Members information on material regulatory developments and trends relevant to the RC generally, OPDP issues and a given promotional Material
• Provide guidance for team on overall benefit/risk assessments of promotional activities and strategies
• Assist with the development of policy and internal guidance
• Effectively communicate regulatory issues and concerns to senior governance group
including Marketing, Legal and Medical.
• Ensure business compliance and implementation of and adherence to Regulatory standards
• Regulatory review of any internal and external business communications
• Engage in appropriate activities in order to improve the regulatory environment through
Agency contacts: Office of Prescription Drug Promotion (OPDP) and trade associations as appropriate.
• Mentor newer staff members across the varied disciplines across multiple review
• Enhance collaboration across a matrixed organization while developing and maintaining
BS or equivalent is required. Science degree/advanced degree is preferred.
Prior Experience Required:
• 7 years or greater regulatory experience including significant Advertising & Promotion
expertise. Launch experience a plus
• Demonstrable experience of effective delivery in complex matrix environment
• Strong negotiation and communication skills
• Experience interacting with FDA required: experience with OPDP preferred
• Level of the selected candidate will be determined based upon multiple factors including relevant education, overall experience, and prior track record
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
A little about us:
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