What are the responsibilities and job description for the Senior Manager, Medical Writing position at Intellia Therapeutics?
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 wantall ofour 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.
Senior Manager, Medical Writing
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
Supervisory Responsibilities
N / A
Requirements
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
Prolonged periods of sitting at a desk and working on a computer
Manual dexterity for keyboarding; may include repetitive movements
Covid-19 Vaccination Policy : All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.
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.
