
Description
At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases.
Job Summary
As Senior Manager, Medical Writing within the Development Operations organization, you will be responsible for creating, authoring, and leading the management of key program documents such as clinical protocols (and amendments), clinical study reports, investigator’s brochures, and other documents required for regulatory submissions.
In this opportunity, you will collaborate with and actively participate in cross-functional teams, such as clinical operations, data sciences, regulatory affairs, R&D medical, biostatistics, drug safety and pharmacovigilance, and program management. In addition, you may partner with Contract Research Organizations (CROs) and co-development partners.
Duties/Responsibilities
- Coordinate development of, and serve as principal writer for clinical protocols/amendments, clinical study reports, investigator brochures, and Module 2 summaries.
- Ensure adherence to clinical and regulatory writing timelines, standards, and processes.
- Organize and lead document development and review meetings.
Requirements
- A solid understanding of the drug development process including clinical study conduct and data collection and analysis.
- A solid understanding of ICH and GxP guidelines.
- Demonstrated understanding of standard clinical document types (i.e., protocol, investigator’s brochure, clinical study reports, etc.).
- Proficiency with templates and style guides.
- Strong interpersonal, negotiation, verbal, and written communication skills.
- Strong organizational and meeting skills and attention to detail.
- Takes ownership of a given assignment, solves problems associated with medical writing scope of work, seeks advice from management and others as needed, and exercises negotiation and communication skills with project team members.
- Bachelors, Masters, PharmD or Ph.D. in a life science or health discipline.
- At least 2 years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry.