ABOUT THE NEST
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
ABOUT THE FLOCK
The Regulatory Advertising and Promotion flock is all about working collaboratively with cross-functional birds to develop compliant communications about bbb products and disease awareness. Whether it’s completing our Veeva PromoMats reviews on time, finding creative approaches in messaging, or educating our cross-functional birds on relevant regulations and FDA guidance documents, we are driven by our commitment to ensure bbb communications are accurate and non-misleading. Come work with a passionate group of birds that loves rising to the challenge much as we do evaluating the latest FDA enforcement letter!
HOW YOU’LL FLY
As a Regulatory Advertising and Promotion bird reporting to the VP, Regulatory Labeling, Advertising and Promotion, you'll help to bring more patients their bluebird days by:
- Leading regulatory discussion and review of US and Global promotional and disease awareness materials in the bluebird bio Medical, Legal and Regulatory (bMLR) Review Committee for assigned products
- Driving the strategic assessment of regulatory ad promo risks and benefits to ensure compliance of promotional and non-promotional external communications
- Supporting strategy and planning for product launches
- Directing and ensuring the timely submission of all applicable promotional materials to the US FDA (e.g. Form FDA 2253 and Advisory Comments)
- Driving process improvement initiatives and building best practices related to advertising and promotion
- Successfully working with Commercial, Medical, Legal and other cross-functional birds to build compliant product promotional materials and disease awareness materials
- Participating in regulatory intelligence activities; monitor regulatory guidelines and enforcement trends
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- Advanced degree in regulatory, pharmacy, chemistry, biology or an MBA preferred
- Have 6+ years of regulatory experience in US advertising and promotional material review
- Are familiar with Veeva PromoMats electronic review system
- Have experience with developing communications that are consistent with FDA-required labeling (CFL) and pre-approval payor communications
- Have product launch experience, including submitting draft promotional materials to OPDP/APLB for advisory comments
- Able to work effectively in a collaborative team environment where results are achieved through influence and incorporation of multiple points of view
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.