Associate Director, Nonclinical Scientific Writing
Company: Intellia Therapeutics
Location: Cambridge
Posted on: March 19, 2023
Job Description:
Associate Director, Nonclinical Scientific Writing page is
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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.
Keywords: Intellia Therapeutics, Cambridge , Associate Director, Nonclinical Scientific Writing, Advertising , Cambridge, Massachusetts
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