Reporting to the Head of Clinical Operations the Associate Director/Director of Medical Writing will be a key member of the clinical operations team, working closely with the cross-functional AVROBIO team. The position provides an excellent opportunity to gain experience and learn broad aspects of gene therapy regulations. You will manage all aspects of clinical and regulatory document preparation and finalization at the program and study level as well as contribute in meaningful ways to data analysis and interpretation. As a key member of the team, you will have the opportunity to provide strategic direction cross-functionally to ensure key messages are consistently aligned with reporting requirements and company objectives.
- Review and edit documents prepared by other writers (internal functional area representatives, CRO, or contractors) as required and ensure quality and adherence to standards
- Independently prepare complex regulatory and clinical documents including protocols, Investigator’s Brochures (IBs), development safety update reports (DSURs), clinical study reports (CSRs), regulatory briefing documents, and clinical sections of regulatory submissions (IMPDs, INDs, CTAs, MAAs and BLAs)
- Oversight of CRO or consultant medical writers
- Own the document development lifecycle by maintaining and driving document review cycles and timelines
- Contribute to overall project management and cross functional working groups as needed to facilitate efficient development and finalization of documents for submissions
- Ensure document adherence to standard operating procedures (SOPs), good clinical practice (GCP), and the International Council on Harmonisation (ICH)
- Perform quality control of medical writing documents
- Assist in the development of templates, style guidelines, and SOPs
- Generate or assist in evaluating proposals, contracts, and change orders from CROs and other vendors.
- Demonstrated ability to communicate and write clearly, concisely, and effectively
- Ability to complete tasks to deadlines and resolve/escalate problems in a timely manner under limited direction and on own initiative
- Experience with cross-functional study teams
- Proficient in Microsoft Word, Excel, Please Review, Sharepoint or other joint writing/editing tools
- Strong analytical skills and ability to interpret and present complex data clearly
- Independently motivated, and good problem-solving ability
- Aptitude for compilation, analysis, and presentation of data
- Ability to work successfully within a cross-functional team and a matrix organization.
- Knowledge of current regulatory requirements and guidelines governing clinical research.
- Ability to manage and communicate effectively with vendors including reviewing requests for proposals, analyzing scope of work, and responding to inquiries and complaints.
- Must be able to work in a fast paced environment with demonstrated ability to manage multiple competing tasks and demands.
- Performs other work-related duties as assigned
- 10+ years clinical/regulatory writing experience with Master’s degree OR 8+ years clinical/regulatory writing experience with PhD in life science or equivalent.
To apply, email your resume to: firstname.lastname@example.org
AVROBIO, Inc is an EEO employer
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.