Principal Medical Writer

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

Company:

 

Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for patients with kidney diseases. We apply our proprietary research platform to discover and develop therapies with novel mechanisms of action in key kidney disease pathways. Our development focus is on rare, serious disorders with clear unmet medical needs and well-defined clinical development opportunities. Our lead program, atrasentan, is a potent and selective, small molecule inhibitor of the endothelin A receptor that is planned to move into a phase 3 registrational trial for IgA nephropathy and a phase 2 basket trial for glomerular diseases, in 2021. We are advancing BION-1301, an anti-APRIL monoclonal antibody, in an ongoing phase 1b trial for IgA nephropathy, and CHK-336, an oral small molecule LDHA inhibitor for primary hyperoxaluria, towards trial initiation in 2021. Our pipeline also includes several additional preclinical programs at the validation and lead optimization stages, and we continue to actively evaluate business development opportunities around early and late-stage clinical assets in kidney disease. 

 

Chinook completed the third quarter of 2020 with over $290 million in operating capital and trades on Nasdaq under the ticker symbol, “KDNY.”  The company has locations in Vancouver, BC, Seattle, WA and Berkeley, CA.

 

Position:

 

The Principal Medical Writer/Associate Director will report to the Head of Medical Writing.  Responsibilities will include development of clinical-regulatory documents and clinical communications in support of Chinook’s early and late-stage drug development programs as well as to support medical writing departmental processes and infrastructure. 

  

 Responsibilities include:

 

  • Development of clinical protocols and amendments, clinical study reports, investigator brochures, clinical sections of IND/NDA and other documents to support global product development.
  • Assist with the development of abstracts, slides, and posters for clinical data presentation at medical conferences.
  • Assist with oversight of manuscripts for publication in peer-reviewed journals.
  • Partner with biostatistics for early planning and input for SAP and review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents.
  • Work closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources.
  • With minimal oversight, act as lead on assigned projects to drive the overall process for document development including timelines, content development, document review, and approvals.
  • Prepare documents in accordance with internal standards and external regulatory guidelines.
  • Develop and implement document templates, style standards, reference library, reviewer guidelines, and standard operating procedures to ensure consistent and high-quality deliverables.
  • Assist with external vendor oversight as applicable.

 

Education, Experience, and Skills:

 

  • Minimum of 8-10 years of clinical experience within medical writing (Sponsor or CRO).
  • Bachelor’s degree in life sciences; Masters or doctorate degree qualification in life sciences is preferred.
  • Expertise in preparing clinical-regulatory documents and/or scientific publications.
  • Prior IND/NDA/MAA submission experience preferred.
  • Excellent written and verbal communication skills.
  • Strong ability to interpret and present statistical and clinical data.
  • Fluency in Microsoft Word, PowerPoint, and Adobe Acrobat.
  • Excellent project management skills to organize work and to influence and guide teams during document development.
  • Excellent interpersonal skills and demonstrated ability to establish and maintain professional and productive cross-functional working relationships.
  • Advanced knowledge of FDA regulations, ICH guidelines, Good Clinical Practices, medical terminology, and the drug development process.
  • Ability to multi-task in a fast-paced environment.
  • Consideration given to candidates with therapeutic experience in kidney disease.

 

Chinook is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground.

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