Associate Director, Publishing Operations
Job Description
ABOUT THE NEST
The nest is a place where every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, you're not just landing a new gig, you become part of a flock that's pursuing curative gene therapies to give patients and their families more bluebird days. We are doers, thinkers and collaborators who embrace and live by our values:
- Persist for Purpose
- Be Compassionate
- Stay humble and curious
- Keep it real
- Celebrate (sm)all wins
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
ABOUT THE FLOCK
The Regulatory flock is all about making a profound impact on people living with rare diseases through teamwork, strategic conviction, operational focus, and individual accountability to the mission of establishing gene therapy as a meaningful option for patients. We are looking for an experienced regulatory publisher to support marketing and clinical submissions for all therapeutic areas across the portfolio. Come work with a kickass group of birds that are committed to be the change that we want to see in the world….and have some fun together along the way!
HOW YOU’LL FLY
You'll help to bring more patients their bluebird days by:
- Applying in-depth knowledge of US, EU, and ROW submission requirements and standards.
- Applying knowledge of major marketing and post-approval submission requirements for US/EU, typically developed through extensive experience successfully leading initiatives within an area of specialization.
- Managing and leading publishing activities as well as publishing documents as an individual contributor.
- Working with Project and Submissions Management colleagues to determine publishing timelines and plans as needed to support development and program team goals.
- Serving as the point person for publishing activities and sharing best practices within area of specialization.
- Providing creative solutions and successfully spearheading new initiatives.
- Operating as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues.
- Staying current on new electronic submission and regulatory documentation practices issued from global health authorities.
WHAT YOU’LL BRING
You’re the bird we’re looking for if you have:
- Bachelor's degree in life-sciences, computer science or related field, plus seven (7) years of experience in regulatory operations with a focus in dossier publishing. Experience may be gained concurrently and must include:
- 5 years in each of the following:
- Delivery of timely and compliant submissions including eCTD, marketing and clinical
- Serves as point person for publishing activities and sharing best practices within area of specialization
- Applying advanced knowledge in publishing activities including publishing and formatting documents, building submission and approval workflows, and directing escalation pathway within area of specialization
- 3 years in each of the following:
- Applying in-depth knowledge of US and EU submission requirements and standards
- Applying basic knowledge of ROW submission requirements and standards
- 5 years in each of the following:
- Extensive experience using document management / regulatory information management systems
- Deep experience using dossier publishing systems and tools such as Veeva RIM and IQVIA RIM Smart
- In depth knowledge of US and EU publishing/documentation regulations and requirements
- Experience managing external vendor support
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.
Date Posted
11/01/2022
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