Director of Scientific Writing and Communications (ADX-66-20)

THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com

ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhances genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.

POSITION SUMMARY:

Residing in the Boulder office, the Director of Scientific Writing and Communications leads a team in generating scientific, medical, regulatory and technical documentation for the CDx/IVD, marketing, clinical operations and R&D teams at ArcherDX. This position will report to the Chief Medical Officer and oversee research, writing and editing of pre-clinical and/or clinical protocols, diagnostic analytical validations, and other studies. They will prepare ​and/or supervise the generation of reports, summary documents, package inserts and other documents that may be submitted to regulatory authorities, publication in scientific journals, presentation at international congresses and internal communication purposes.

In addition, the Director will oversee the development of SOPs, templates, formats and guidelines for clinical and scientific documentation. They will prepare manuscripts, abstracts and posters and will keep abreast of professional information and technology through literature searches and conferences.
RESPONSIBILITIES:

• Oversees the Scientific Writing team, including managing and evaluating the performance of 2 or more direct reports and contractors
• Monitors overall quality of writing from a scientific and technical perspective from team members and contractors
• Mentors and develops writing team through direct supervision, coaching and other feedback mechanisms
• Develops templates, checklists, SOPs and training materials
• Works with leadership and PMO to determine workload, prioritization and delegation of projects to members of the writing team
• Manages numerous and overlapping projects
• Consistently meets deadlines and works within timelines of projects
• Writes, reviews, and revises documents with an eye to formal writing, scientific content, and compliance with Quality Assurance practices and regulatory guidelines
• Ensures 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
• Fosters positive relationships between writing team and functional areas
• 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 practices
• Prepares strategy, plans and timelines of publications In journals and/or presentations at congresses
• To assist in strategic development of domestic and international regulatory filings, white papers, peer-reviewed publications and other documentations.
• To participate in strategic prioritization of company objectives as part of the broader leadership team
• To participate in discussions with the FDA or other regulatory bodies regarding the required data and documentation for various regulatory filings
• To continue to develop and expand the writing team's personnel and resources to be consistent with company goals and needs

QUALIFICATIONS:

• 5+ years of managerial experience supervising and editing the work of scientific/medical writers
• 5+ years of experience scientific writing and communications in the diagnostics, biotech, pharmaceutical, or medical device industry working or under a Quality Management System in a regulated environment
• 1+ years of clinical, laboratory or high throughput sequencing experience (preferred) 
• Demonstrated expertise in producing and editing scientific content
• Highly proficient in Word and Microsoft Office Suite and other tools to support document or presentation development
• Strong verbal communication and presentation skills
• Experienced in collaborative document development and tools for document collaboration
• Highly proficient in medical and scientific style and format (AMA, CSE)
• 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
• Experience with basic statistics/bioinformatics for biology and high throughput sequencing (preferred)
• Knowledge of FDA regulations and CDx approval processes (preferred)

EDUCATION:

• MS, or PhD in life sciences, or other relevant field