Manager, Medical Writing

Medical Writing (640) · Seattle, Washington
Department Medical Writing (640)
Employment Type Full-Time
Minimum Experience Manager/Supervisor

Company:

 

Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for kidney diseases. Chinook’s product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook’s lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and other proteinuric glomerular diseases. BION-1301, an anti-APRIL monoclonal antibody is being evaluated in a phase 1/2 trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, an oral small molecule LDHA inhibitor for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases.

 

Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids, and new translational models, to discover and develop therapeutics with differentiating mechanisms of action against key kidney disease pathways. Chinook trades on Nasdaq under the ticker symbol KDNY and has locations in Vancouver, BC, Seattle, WA and Oakland, CA.


Position:

 

The Manager, Medical Writing will be responsible for developing and authoring clinical and regulatory documents on cross-functional study teams in support of Chinook’s early- and late-stage drug development programs. The role will report into the Director of Medical Writing and can be based on Seattle, Oakland, Vancouver BC, or remote.

 

 Responsibilities include:

 

  • With minimal supervision, develop and author clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), submission documents (clinical summaries and clinical overviews), and other medical/regulatory documents needed to support global product development.
  • Work closely with study teams to gain a comprehensive understanding of the clinical data s to ensure documents are scientifically accurate and meet the intended purpose.
  • Partner with the Director of Medical Writing to create and refine document development processes to facilitate the preparation of high-quality clinical and regulatory documents in a timely manner.
  • Drive the overall process for document development, including the creation of timelines, fostering team-member engagement, guiding content development, and leading document reviews and approvals.
  • Prepare documents in accordance with internal standards and external regulatory guidelines.


Education, Experience, and Skills:

 

  • Minimum of 2 years of direct medical writing experience in the biopharmaceutical industry.
  • Bachelors degree in a life science or related field. Masters or doctoral degree qualification in the life sciences is preferred.
  • Expertise in preparing clinical regulatory documents and/or scientific publications. Prior NDA/BLA/MAA submission experience is preferred.
  • Excellent written and verbal communication skills.
  • Expertise in interpreting and presenting statistical and clinical data.
  • Proficiency in the use of Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
  • Demonstrated ability to lead and manage projects
  • Excellent interpersonal skills and demonstrated ability to establish and maintain professional and productive cross-functional working relationships.
  • Familiarity with FDA regulations, ICH guidelines, Good Clinical Practices, and the drug development process.

 

Chinook is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported.  We respect and value different experiences and viewpoints.  We act respectfully toward one another and embrace diversity of people and ideas. Having a diverse workforce made up of team members who bring a wide variety of skills, abilities, experiences, and perspectives is essential to our success. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.

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  • Location
    Seattle, Washington
  • Department
    Medical Writing (640)
  • Employment Type
    Full-Time
  • Minimum Experience
    Manager/Supervisor