About the Department
Dicerna, a Novo Nordisk company, is focused on driving innovation in RNAi (ribonucleic acid interference) to selectively target and silence genes that cause or contribute to disease. Our proprietary GalXC™ and GalXC-Plus™ RNAi technologies have the potential to address conditions that are difficult or impossible to treat with other modalities. Established as a Transformational Research Unit (TRU) following Novo Nordisk's acquisition of Dicerna Pharmaceuticals, Inc. in December 2021, the Dicerna TRU is a unique new organization within Novo Nordisk that brings together the best of both worlds - the agility, collaborative pioneering spirit and calculated risk-taking profile of a biotech along with the scale, resources and capabilities of a global leader in drug development. With approximately 200 researchers, scientists, drug developers and operational staff, we are a team of inventive and entrepreneurial thinkers pushing the boundaries of science to create and drive new RNAi-based therapies for both rare and more prevalent diseases from the bench to the clinic. Together, we are driving change. Are you ready to make a difference?
The Position
The nonclinical writer will be a key member of the Program Development Team and will work closely with colleagues in the nonclinical groups to manage all aspects of preparation for regulatory documents and scientific reports according to company guidelines and international governmental regulations. The individual will provide strategic direction to cross-functional teams to ensure that key messages are consistently aligned with reporting requirements and company objectives.
Relationships
Reports to Senior Nonclinical Writer, Program Development. This position may be located out of our Lexington, MA or our Boulder, CO location
Essential Functions

• Plan, author, edit, format, and finalize nonclinical regulatory documents; including, but not limited to: IND, CTA, summaries and updates to regulatory submissions, annual reports etc.
• Work with nonclinical research colleagues to author scientific reports and invention disclosure summaries
• Work with program development teams and the medical writing staff to assist in developing strategy for organizing and preparing documents for regulatory health authority submissions
• Coordinate the internal review of nonclinical documents
• Develop, maintain, and drive document finalization timelines
• Ensure final documents adhere to internal standard operating procedures (SOP) and the International Council on Harmonisation (ICH)
• Perform quality control (QC) review of documents
• Assist in the development of templates, style guidelines, and SOPs for documentation
• Potential to expand into nonclinical study monitoring

Physical Requirements
Up to 10% overnight travel required.
Qualifications

• Bachelor's degree required.
• 4+ years of nonclinical and/or scientific writing, preferably within pharmaceutical/biotech industry and/or Contract Research Organization
  • An advanced degree may substitute for some years of experience as deemed appropriate.
• Ability to interpret and present nonclinical data objectively in a clear, concise format
• Proven written and oral communication skills
• Proficiency in teamwork, organization, and project management
• Proficiency in MS Office
• Experience with GLP study monitoring a plus

The base compensation range for this position is $100,000 to $108,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.
Novo Nordisk offers long-term incentive compensation depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
The job posting is anticipated to close on April 24th, 2024. The Company may however extend this time-period, in which case the posting will remain available on our careers website at www.novonordisk-us/careers.com.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.