Why Join Intellia?
Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.
We want all of our people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.
How you will Achieve More with Intellia:
Reporting to the Head of Medical Writing, you will lead the development of key documents supporting clinical programs and regulatory submissions. In this opportunity, you will collaborate with cross-functional teams including representatives from clinical operations, regulatory affairs, medical, biostatistics, drug safety/pharmacovigilance, clinical pharmacology, translational medicine, data sciences, and program management. In addition, you may interact with contract research organizations (CROs) and co-development partners. Key responsibilities include:
Coordinate development of, and serve as principal writer for, clinical protocols/amendments, clinical study reports, investigator brochures, Module 2 summaries, and other elements of regulatory submissions as well as abstracts, posters, and manuscripts
Organize and lead document development and review meetings
Develop and ensure adherence to clinical and regulatory writing timelines, standards, and processes
Critically review statistical analysis plans to ensure alignment with anticipated data presentations in clinical study reports and Module 2 summaries
Perform literature-based research to support writing activities
Lead medical writing and cross-functional initiatives pertaining to document standards, template development, and processes
Are you intellectually curious and fascinated by the possibilities of gene editing? Can you lead conversations and help teams reach a consensus on scientifically complex questions and presentations? Our ideal candidate will possess a solid understanding of the drug development process including clinical study conduct, data collection and analysis, and regulatory interactions. Other key attributes include:
At least 4 years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
A Bachelor's degree, Master's degree, Pharm-D, or Ph.D. in a life science or health discipline
A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements
Demonstrated understanding of standard clinical document types (i.e., protocol, investigator’s brochure, clinical study reports, etc.) and experience as a lead author with such documents
Proficiency with templates and style guides
Strong interpersonal, negotiation, verbal, and written communication skills
Strong organizational and meeting skills and attention to detail
Willingness and ability to take ownership of a given assignment, solve problems associated with medical writing scope of work, determine when advice from management and others as needed, and demonstrate negotiation and communication skills with project team members
Meet your future team:
The position reports to the Head of Medical Writing. It is envisioned that the Medical Writing function at Intellia will comprise both in-house writers and contract writing support. The writing team partners with functions across the development organization, offering broad exposure to the business and providing the ability to influence and help shape the future of Intellia.
At Intellia, our cross-functional program teams promote shared accountability toward a common goal, bringing transformative and curative treatments to patients in need. There is no road map for what we are doing as leaders in the systemic delivery of in vivo and ex vivo CRISPR-Cas9 therapies. We thrive on charting new territory, exploring new ways to drive our programs and the business forward while promoting and cultivating the culture of ONE that has made Intellia such an incredible place to work. We look forward to fostering your skills and strengthening our leadership through your contributions and working together as ONE to find a cure.
Covid-19 Vaccination Policy: Effective Monday, January 3, 2022, all Broad employees, regardless of work location, must be fully vaccinated for COVID-19. Requests for exemption for medical or sincerely held religious beliefs will be considered.
EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.