Director of Medical Writing

Location
Cambridge, MA, United States
Posted
Nov 26, 2018
Ref
1395346
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
Director of Medical Writing
Clinical-stage, fast-growing gene therapy company

Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. Reporting to our Vice President, Medical and Technical Writing, the primary deliverables for this role are clinical regulatory documents according to applicable regulations. It is envisioned that this person will play a leadership role in future key regulatory submissions to the FDA and EMA.

About the role:
• Provide leadership in planning and completing key submission documents (e.g., Clinical Summaries of Safety and Efficacy, Clinical Overview) for submissions to the FDA and EMA
• Contribute to overall project management and to cross functional working groups (clinical operations, clinical development, data management, statistics) as needed to facilitate efficient development and finalization of clinical, nonclinical and regulatory documents for submissions
• Manage the work of CRO contract writers, as needed
• Work with the clinical and regulatory teams to prepare protocols, clinical study reports, Investigator's brochures, safety updates, and IND clinical sections in CTD format under strict timelines
• Participate in recruiting and mentoring of staff, and budget planning

About you:
• PhD in a Life Science or equivalent
• At least 5 years in medical writing, including participating in submissions to the US FDA (NDA, BLA) and EMA (MAA), with supervisory experience
• Experienced in the preparation of protocols, study reports, investigator brochures, safety updates, and IND clinical sections
• Demonstrated ability to communicate and write clearly, concisely, and effectively, with an aptitude for compilation, analysis, and presentation of data
• Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high quality documents according to tight timelines
• Wide knowledge of biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology
• Independently motivated, and good problem-solving ability
• Ability to think strategically to further project and departmental development
• Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself