Senior Manager, Regulatory Affairs Advertising and Promotion

The Asspcoate Dirctor, Regulatory Affairs Advertising & Promotion will be responsible for providing strategic, operational and tactical regulatory advice to internal stakeholders regarding communications about investigational product pipeline assets and approved prescription products ensuring they comply with US laws and regulations and company policies, while supporting achievement of business objectives. Provides regulatory review of advertising and promotional labeling, disease awareness and training materials, new campaigns, and product launch strategies.

What you will be doing:

• Serves as subject matter expert on FDA regulations and OPDP guidance governing promotion and prescription drug/ biologic products and disease awareness activities.
• Participates on multidisciplinary medical, legal and regulatory review team with individual responsibility for the review, risk assessment, and Regulatory decisions regarding product communications.
• Provides regulatory strategic oversight for at least one (1) complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional and non-promotional materials assigned, including management of Form 2253 submissions.
• Ensures that US Prescribing Information (USPI) is accurately and contextually applied to relevant external communications and changes to USPI are incorporated within a timely manner.
• Monitors and keeps organization abreast on US regulatory promotional environment (e.g., the issuance of new FDA regulations/guidance documents, relevant FDA enforcement action and general awareness of industry practices, including those of competitors).
• Contributes to culture of compliance by participating as needed in training personnel on promotional, marketing, labeling and advertising regulations and updates.

• Ability to maintain collaborative, efficient, and effective working relations with cross-functional teams (commercial, medical, legal and regulatory).
• Strong interpersonal, oral and written communication skills
• Understands business goals and common marketing concepts/tools
• High degree of professional ethics, integrity and responsibility
• Shows flexibility and is open to change in a growing, multi-cultural environment
• Capable of strategic thinking and proposing innovative solutions involving regulatory issues, while being a team player who invites response and discussion
• Comfortable in a fast-paced, results-driven, and highly accountable work environment
• Analytical and Problem-Solving Skills - ability to understand complex issues and propose achievable solutions
• Working knowledge of Veeva PromoMats
• While this position is categorized as “remote” it is preferable if candidate is able to attend occasional meetings that may involve overnight stays in Boston, MA

Minimum Qualifications

• 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.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.