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
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. Reporting to our Senior Manager of Medical Writing, the primary deliverables of this role are clinical regulatory documents according to applicable regulations. Documents will include (but are not limited to) protocols, Investigator's Brochures, annual reports, clinical study reports, regulatory briefing documents, and clinical sections of INDs, CTAs, and BLAs.
HOW YOU'LL FLY
You'll help to bring more patients their bluebird days by:
- Working with cross-functional teams to prepare regulatory documents in CTD format under strict timelines
- Ensuring efficient and consistent formatting of documents, to maintain quality and ease of review across multiple documents assembled in a regulatory dossier
- Contributing to overall project management and to cross functional working groups as needed to facilitate efficient development and finalization of regulatory documents for submissions
WHAT YOU'LL BRING
You're the bird we're looking for if you have:
- PhD in a Life Science or equivalent
- 2-5 years of regulatory Medical Writing experience (preferred)
- Demonstrated ability to communicate and write clearly, concisely, and effectively
- Strong organizational skills, ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines
- Working knowledge of biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology
- Logic, accuracy, and detail-orientation, are independently motivated, and able to problem-solve
- Ability to collaborate with teams of cross-functional contributors to produce a final, unified document
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.
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