Medical Writer/Sr. Medical Writer

Redmond, WA

Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor.  

This position is Remote, U.S. 

Summary:

  • The Medical Writer/Sr. Medical Writer will be responsible for independently authoring and revising clinical and regulatory documents for submission to the FDA and other agencies, and to lead other clinical communication efforts, including the development of abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals. The Medical Writer/Sr. Medical Writer will be expected to support multiple studies, programs, and/or indications. 

Principal Responsibilities:

Includes but not limited to: 

  • Leads the development and authoring of Investigational New Drug applications, clinical protocols, clinical study reports, investigator brochures, and clinical summaries in support of regulatory filings 

  • Leads the development and authoring of abstracts, posters, slides of clinical study data at medical congresses and the development of primary manuscripts for publication in peer-reviewed journals 

  • Provides medical writing support for briefing documents, information requests, nonclinical summaries, and additional documents intended for submission to HAs 

  • Facilitates document review committee meetings and issues resolution 

  • Provides project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents 

  • Organizes, conducts, and leads cross-functional document development meetings 

  • Closely interacts with statistics and programming departments in the development of statistical analysis plans and design of statistical outputs 

  • Routinely engages clinical research and biostatistics to gain comprehensive understanding of compound and the design, objectives, and results of clinical trials to enable accurate and effective communication to varied audiences 

  • Represents medical writing on study/project teams and contributes to program strategy, through collaborative engagement with personnel from other clinical disciplines, regulatory affairs, and scientific departments 

Required Qualifications:

  • Minimum of 8 years of experience in the biopharmaceutical industry, with 5 years of direct medical writing experience; advanced degree(s)/academic research/transferable skills may be considered in lieu of industry experience 

  • BA/BS

Preferred Qualifications:

  • Masters or doctorate degree in life sciences 

  • Excellent written and verbal communication skills with the ability to interpret and present scientific data 

  • Ability to work cross-functionally 

  • Skilled in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat 

  • Awareness of FDA regulations, ICH guidelines, Good Clinical Practices and the drug development process 

  • Must have the ability to independently coordinate and prioritize multiple projects in a fast-paced environment 

Systimmune offers a flexible schedule, competitive salary, and a generous benefits package. Including health/dental/vision, employer retirement match, and paid time off!

Apply now