Sr. Science Writer

The Sr. Science Writer is responsible for independently authoring and delivering high-quality protocol and regulatory documents and represents Medical Writing as a cross-functional team member for clinical study-level activities in the Clinical Research Support division. Clinical Research Support is the central clinical trials office at Fred Hutch that serves Fred Hutch and the UW/Fred Hutch/Seattle Children’s Cancer Consortium, and clinical research conducted at the Consortium’s main campuses and community sites. Clinical Research Support’s mission is to ensure the conduct of efficient, compliant and high quality clinical research throughout the Cancer ConsortiumWe are actively expanding our central team to support Principal Investigators (PIs) and research study teams who are focused on mission-critical clinical trials programs.. This position will work directly with the Assistant Director, IIT Protocol Development.

Most Fred Hutch jobs require some on-campus work. However, there may be flexibility for certain positions. Please check with the recruiter if you are an out-of-state applicant interested only in working outside of the Seattle area.

Responsibilities 

• Independently writing and delivering high-quality clinical trial and regulatory documents (e.g., clinical study protocols and sections of regulatory documents) in partnership with internal cross-functional team members.
• Developing clincal trial study documents for clarity, accuracy, and consistency.
• Coordinating effective document development, review, and approval. 
• Actively contributing to development of processes and procedures to improve departmental and cross-functional workflows. 
• Building relationships and working collaboratively with study team members.
• Developing in-depth study-level knowledge. 
• Contributing scientific knowledge and analytical skills to the production of documents. 
• Participating in developing key messages for clinical regulatory documents.
• Developing document timelines and communicating with team members to maintain awareness of expectations, milestones, and deliverables.

Qualifications 

• Bachelor’s degree and 5+ years formal scientific writing experience required, ideally writing related to clinical study protocols.
• Ability to analyze, interpret, and summarize clinical trial data. 
• Self-motived and nimble with the ability to excel in a fast-paced environment. 
• Excellent written and verbal communication skills.
• Strong interpersonal skills.
• Experience producing high-quality scientific/medical documents. 
• Basic understanding of drug development, clinical research, study design, biostatistics, regulatory requirements, and medical terminology.
• Strong project management and organizational skills. 
• Initiative and creativity in solving routine problems for individual documents and in identifying process improvements within the IIT Protocol Development team.  
• Attention to detail related to consistency, grammar, syntax, and scientific accuracy.
• Proficiency in word processing, templates, table/figure creation, and literature searches.