Director of Medical Writing
We are seeking a talented and dynamic medical writer to join our growing development organization. Reporting to the Head of Clinical Operations, you will be a key member of the clinical development team, working closely with the cross-functional team. The position provides an excellent opportunity to gain experience and learn broad aspects of gene therapy/editing 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 clinical study 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.
- Independently prepares 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)
- Owning the document development and delivery process by maintaining and driving document review cycles and finalization timelines
- Contribute to overall project management and to cross functional working groups as needed to facilitate efficient development and finalization of documents for submissions
- Ensuring documents adhere to standard operating procedures (SOPs), good clinical practice (GCP), and the International Council on Harmonisation (ICH)
- Performing quality control review of medical writing documents
- Assisting in the development of templates, style guidelines, and SOPs
- 10+ years clinical/regulatory writing experience with Master’s degree OR 8+ years clinical/regulatory writing experience with PhD in life science or equivalent
- Solid understanding of the basic principles of biochemistry and molecular biology
- Demonstrated ability to communicate and write clearly, concisely, and effectively
- Experience driving documents through from start to finish with tight timelines and 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
- Working knowledge of biologics development and manufacture, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
- Experience working in a small biotech environment
- Experience writing for oncology indications
- Detailed knowledge of requirements for preparation of key clinical and regulatory documents for INDs, CTAs, BLAs and annual reports
- Collaborative – Openness, One Team
- Undaunted – Fearless, Can-do attitude
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
If interested and qualified, please include Requisition # 2018-360 in the subject line when emailing resume to: email@example.com.
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