Corporate Compliance Specialist responsible for audits and regulatory education in healthcare. Requires collaboration with various departments to ensure compliance and maintain documentation.
About the role
- Associate Director leading US advertising and promotional compliance strategy for life sciences. Collaborating with cross-functional teams to ensure alignment with FDA requirements and ethical standards.
Responsibilities
- Reviewing US promotional and non-promotional/scientific material, attending review meetings and providing regulatory guidance to the cross-functional team responsible for ensuring adherence to global compliance standards and FDA regulations pertaining to prescription drug advertising, promotion, and communication as applicable
- Serving as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and /or Advertising and Promotional Labeling Branch (APLB) for assigned products, including responsibilities for the timely preparation and submission of promotional materials under cover of FDA Form 2253
- As needed, providing training support within Alexion on regulatory requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific conferences
- In collaboration with their manager, providing advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products
- Ensuring stakeholder awareness of proposed and newly approved labeling changes
- Informing, reviewing and providing clear communication to all key stakeholders in both Promotional Review Committee (PRC) and Medical Review Committee (MRC) on planned label updates and how they may impact promotional and medical materials; provide key stakeholders with specific guidance on appropriate implementation of the label update, including ISI updates, for assigned therapeutic area in a timely manner
- In collaboration with their manager and the Medical Legal Regulatory (MLR) Coordinator, participating in developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials; develop best practices to establish standards and consistency across company products
- Maintaining regulatory expertise in product promotion compliance by keeping current with issued FDA enforcement actions and through attendance at relevant conferences and/or seminars
- Communicate new regulatory standards pertaining to prescription drug promotion to brand teams and management, as appropriate
- Working with management and cross-functional partners to analyze changes to the regulatory landscape and determine any internal impact and communicate and provide guidance to all impacted key stakeholders
- Collaborate with ad/promo team and Reg Ops on creation and implementation of novel submission processes
- Participating/assisting in US labeling negotiations and FDA meetings as necessary
Requirements
- Bachelor’s Degree
- Minimum 5 years of relevant experience and/ or relevant PharmD post-doctoral Fellowship experience
- 5 years of U.S. advertising and promotional regulations
- Experience communicating and negotiating directly with OPDP and /or APLB
- Experience with global standards for advertising and promotion compliance
- Proven track record practicing sound judgment as it relates to risk assessment
- Knowledgeable on industry compliance requirements and non-compliance examples and trends
- Demonstrated ability to influence others and foster team collaboration
- Experience with launching new products and/or new indication
- Solid understanding of business goals and common marketing concepts/tools, including the internet and social media
- Proficiency using promotional review software, such as Veeva Promomats and Veeva Medcomms
Benefits
- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage in accordance with the terms of the applicable plans
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