POSITION SUMMARY:

Residing in our Boulder, CO office, the Medical/Scientific Writer generates documentation review for the CDx/IVD Assay Development team at ArcherDX. The Medical/Scientific Writer researches writes and edits pre-clinical and/or clinical reports including diagnostic analytical validations, summarizing data from said studies. Prepares ​analytical validation and clinical reports, summary documents, package inserts and other documents that may be submitted to the Food and Drug Administration and the World Health Organization for publication and/or presentation. Assists in the development of formats and guidelines for clinical documentation. May prepare scientific manuscripts, abstracts, and posters. May also support clinical research associates and medical doctors in clinical protocol development. Keeps abreast of professional information and technology through conferences.

RESPONSIBILITIES:

• Write, review, and revise documents with an eye to formal writing, scientific content, and compliance with Quality Assurance practices and regulatory guidelines
• Ensure consistency of content, style, and format across documents
• Identify and store resources to support protocols, reports, forms, regulatory communications, etc.
• Suggest and/or implement revisions to figures and tables in support of results reporting to enhance clarity, efficacy, and efficiency
• Collect input from internal and external stakeholders to consolidate comments and collaboratively resolve conflicts
• Maintain version control of documents
• Implement safe file transfer to validated file storage locations
• Perform peer review of simple data management and statistical practice

QUALIFICATIONS:

• 2+ years of experience in the biotech or pharmaceutical industry working under a Quality Management System or a combination of education and experience
• Demonstrated expertise in producing and editing scientific content
• Exemplary verbal and written communication skills
• 1+ years of laboratory and high throughput sequencing experience (preferred)
• Highly proficient in Word and Microsoft Office Suite and other tools to support document development
• Highly attentive to detail
• Highly proficient in medical and scientific style and format (AMA, CSE)
• Experienced in collaborative document development and tools for document collaboration
• Knowledge of genetics, molecular biology, and high throughput sequencing
• Able to work in a fast-paced, dynamic, and goal-oriented environment as a member of a team
• Self-starter and capable of working with minimal oversight
• Experience with basic statistics/bioinformatics for biology and high throughput sequencing (preferred)
• Knowledge of FDA regulations and CDx approval processes (preferred)

EDUCATION: