Medical Writer

Location
Cambridge, MA, United States
Posted
Sep 05, 2018
Ref
1240389
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. Reporting to our Senior Director of Medical Writing, this role will provide technical and medical writing support to a variety of regulatory areas that includes CMC, non-clinical, clinical and administrative submissions. The position provides an excellent opportunity to gain experience and learn broad aspects of gene therapy regulations.

Clinical documents will include protocols, Investigator's Brochures, annual reports, clinical study reports, regulatory briefing documents, and clinical sections of regulatory submissions (IMPDs, INDs, CTAs, MAAs and BLAs). Some authoring of nonclinical documents may be included.

About the role:
  • Work with the clinical team to prepare protocols, study reports, investigator brochures, and IND/IMPD clinical sections in CTD format under strict timelines.
  • Work with the nonclinical team to prepare nonclinical reports, and nonclinical IND/IMPD sections.
  • 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.
  • Contribute to overall project management and to cross functional working groups as needed to facilitate efficient development and finalization of clinical, nonclinical and regulatory documents for submissions.

About you:
  • 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
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself