ABOUT THE FLOCK
At bluebird bio, Medical Writers are key members of the Regulatory Science Team and pivotal contributors to the clinical teams for our products. We support and lead our teams through all aspects of clinical documentation, from protocols through Agency licensing submissions and everything in between (and even beyond!). Our Medical Writers are truly valued as scientists and key team members. Come join our team of go-getters!
HOW YOU’LL FLY
You'll help to bring more patients their bluebird days by:
• Providing in-depth knowledge of analysis and presentation of scientific and/or clinical data in regulatory documents
• Working independently on routine documents, with the primary deliverables of this role being clinical regulatory documents consistent to applicable regulations.
• Contributing to clinical documents which will include protocols (but are not limited to), Investigator's Brochures, annual reports, clinical study reports, regulatory briefing documents, and clinical sections of IMPDs, INDs, CT As, and BLAs.
• Contributing to the development of Medical Writing departmental processes, procedures, and tools.
• 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 area (or equivalent experience) with 7 years of regulatory medical writing experience
• Demonstrate the ability to communicate and write clearly, concisely, and effectively
• Well-organized and has working knowledge of biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
• Detailed knowledge of requirements for preparation of key clinical and regulatory documents
• Independently motivated, and good problem-solving ability; able to work with multiple contributors to produce a final unified document

Compensation & Benefits
We offer a total compensation and rewards package that ranks among the best in our industry. Base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The anticipated annualized salary range for this role is $119,000 - $158970. Your base pay will be determined based on several factors including market data, demonstrated skills, relevant education or training, experience, qualifications, internal equity, and travel requirements. Our overall package also includes eligibility for stock, incentive bonuses, and benefit programs, a flexible time off program, as well as 28 paid holidays, including 2 company shutdowns.