Associate Director, Nonclinical Scientific Writing

Company: Intellia Therapeutics
Location: Cambridge
Posted on: March 19, 2023

Job Description:

Associate Director, Nonclinical Scientific Writing page is loaded Associate Director, Nonclinical Scientific Writing Apply locations Cambridge, MA time type Full time posted on Posted 4 Days Ago job requisition id R874 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:As the Associate Director, Nonclinical Scientific Writing, reporting to the Director, Pre-Clinical Operations, you will join our team within Early Development and embrace the opportunity to transform incredible science into powerful cures. You will be responsible for managing how scientific progress is documented to advance novel genome editing therapies into clinical trials. -This opportunity will offer you the chance to grow your technical writing expertise across a range of disciplines such as nucleic acid therapeutics, lipid-nanoparticle drug delivery, viral delivery systems and a range of cell therapy products.

• Lead authoring or reviewing of internally generated scientific reports, summarizing design, results and conclusions to clearly communicate study outcomes. -
• Manages the completion of documents and other assigned tasks within established timelines and with high quality in terms of scientific content, organization, clarity, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
• Effectively oversee the authoring, review, and management of nonclinical regulatory submission components or regulatory documents (e.g., Investigator's Brochures (IBs), Investigational New Drug (IND) applications, Biologic License Applications (BLAs), etc.) for programs across Intellia's Research and Development portfolio.
• Provide guidance on the scientific communication strategy to influence favorable regulatory, patient, investigator and/or external interactions, when needed.
• Participate in the development of Research and Early Development scientific communication processes and standards.
• Apply advanced knowledge of relevant scientific expertise, regulatory requirements, corporate policies, and work experience to evaluate document requirements and identify information gaps or other potential issues.About You:Our ideal candidate will have participated in or lead a major marketing application. 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:
  • Master's degree in life sciences in biochemistry, pharmacology, biology or related pharmaceutical fields including biochemical engineering; Candidates holding a higher degree, such as a PhD will be given preference.
  • Minimum 10 years of relevant biopharmaceutical industry experience, within preclinical and/or scientific writing.
  • Experience working with cell therapy, gene therapy products or mRNA-based therapeutics is a plus.
  • Experience with nonclinical summary sections to support regulatory submissions, including but not limited to IBs, briefing books, INDs, periodic reports, BLAs, and agency responses is highly preferred.
  • Ability to prioritize, manage multiple programs within strict regulatory/compliance deadlines and lead internal/external and scientific teams to regulatory submission.Meet your future team:The Preclinical Operations group is a rapidly growing and valued team within Intellia and is comprised of respected professionals with diverse expertise in both large pharma and small biotech settings. As part of the larger Pre-Clinical Development Group, we are a group of bright, fun, and team first people. Eager to move exciting projects forward, we are motivated by the opportunity to make an impact for patients!The team 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. About Us 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.

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