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.
Medical Writer (Contract)
This role is for a 9-month contract position.
ABOUT THE FLOCK
The Regulatory flock is all about complete and ethical access to information about our clinical research. With your help no longer will patients or researcher need to say ""a little bird told me""!
Whether it’s making sure we maintain transparency compliance through registries, support access to redacted documents, or patient-oriented result summaries, we are driven by responsible clinical trial access, ethics and patient-centric transparency compliance. Come work with a fully integrated transparency group that works cross-functionally with other departmental birds that loves rising to the challenge much as we do to support open access to clinical trial information for patients, researchers and the wider scientific community!
HOW YOU’LL FLY
As a Medical Writer bird reporting to the head of Medical Writing and Transparency within the Regulatory Science team, this role will provide technical and medical writing support to a variety of regulatory documents and submissions with an emphasis upon providing support for Medical Writing operational activities to enhance quality and efficiency for upcoming marketing authorization submissions. The position provides an excellent opportunity to gain experience and learn broad aspects of gene therapy regulations. You’ll help bring more patients their bluebird days by:
- Supporting development of a range of clinical documents including (but not limited to) clinical study reports, regulatory briefing documents, and clinical sections of regulatory submissions (especially MAAs and BLAs)but also protocols, Investigator’s Brochures, annual reports and other documents, as needed.
- Work with the clinical team to support marketing authorization filings by helping to prepare documents such as (but not limited to) protocols, clinical study reports, investigator brochures, and CTD clinical sections under strict timelines.
- Ensure efficient formatting of documents; ensure a consistent style of presentation to maintain quality and ease of review across multiple documents assembled in a regulatory dossier.
- Support coordination of Medical Writing operational activities such as quality control review and coordination of document appendix development
- Responsible for planning, coordinating (with subject matter experts/outside vendors) and in some cases performing Quality Control (QC) review of documents against source (documents and/or data).
- Liaise with both regulatory operations and library management to ensure appropriate assembly and submission of references to regulatory authorities.
- Contribute to overall project management and to cross functional working groups as needed to facilitate efficient development and finalization of regulatory documents for submissions. Leading Clinical Trial Transparency implementation (putting policies into process)
- Other related tasks as needed
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- Bachelor's degree, or preferably PhD in a Life Science or equivalent, with a solid understanding of the basic principles of biochemistry and molecular biology
- Fully fluent in spoken and written English; demonstrate the ability to communicate and write clearly, concisely, and effectively
- Grant and scientific publication writing would be a plus
- Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high quality documents according to tight timelines
- Working knowledge of biologics development and manufacture, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
- Detailed knowledge of requirements for preparation of key clinical, nonclinical and regulatory documents for INDs, CTAs, BLAs and annual reports would be a plus
- Proficient in Microsoft Word and Excel
- Accurate and detail-oriented
- Aptitude for compilation, analysis, and presentation of data
- Independently motivated, and good problem-solving ability
- Ability to work with multiple contributors to produce a final unified document
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.