Manager, Regulatory Project Management

Company: Intellia Therapeutics
Location: Cambridge
Posted on: November 19, 2022

Job Description:

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.How you will Achieve More with Intellia:This role will be responsible for supporting project management activities related to the assigned programs including the end-to-end planning, coordination, and execution of major marketing applications in the United States and Europe through approval as well as additional major submissions as assigned. This role will be support for timeline development/management, meeting facilitation, timely communications, driving deliverables, assessing, and mitigating risks as well as organizing health authority meeting sessions. These meetings will require cross-functional participation to prepare agendas, logistics, and location requirements.

• Use best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment
• System based timeline management: Coordinate input, maintenance, and revision of the project plans for assigned projects, with escalation of unforeseen changes in resource demand, and project conflicts within a timely manner to Project Leadership
• Organize and maintaining team communications including meeting agendas, minutes, decision logs, tasks lists, and risk analyses / mitigation strategies using preferred technologies such as SharePoint, OneNote, and OneDriveAbout You:Are you a regulatory project manager who takes pride in moving programs into the clinics and through to commercialization? Our ideal candidate will have participated on a major marketing application team. If you describe yourself as a great partner and team player who wants to have fun and grow with us, we encourage you to apply! Other desired skills include:
  • A minimum of a BS degree
  • Strong Project Management skills
  • Strong teambuilding skills
  • Strong verbal and written communication skills
  • Highly organized, proactive
  • Ability to proactively analyze issues and develop solutions
  • Demonstrated ability to effectively manage multiple priorities and meet deadlinesMeet your future team:The Global Regulatory Affairs group is a rapidly growing and valued team within Intellia and is comprised of respected professionals with diverse regulatory expertise in both large pharma and small biotech settings. The Regulatory Project Management and Operations group is a big part of the GRA function. We are a group of bright, fun, and team first people. Eager to move cool projects forward, we are motivated by the opportunity to make an impact for patients! Your future manager is the Associate Director, Regulatory Project Management who oversees the project management function.The Global Regulatory Affairs group is currently a mix of remote, hybrid, and onsite, and we are open to applicants working remotely for this role. Although in a virtual environment, the group has made it a priority to continue to foster a sense of community! You can expect to join a hardworking, collaborative environment. Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. 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.

Keywords: Intellia Therapeutics, Cambridge , Manager, Regulatory Project Management, Executive , Cambridge, Massachusetts