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

| Greater Boulder Area
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
 
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 
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Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • D3JSLibraries
    • jQuery UILibraries
    • Twitter BootstrapLibraries
    • DjangoFrameworks
    • PostgreSQLDatabases

Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

An Insider's view of ArcherDX

What’s the vibe like in the office?

Collaborative - when I walk through the ArcherDX office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.

Sarah

Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Archer. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.

Judy

Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.

Aaron

VP of Bioinformatics and Commercial Development

How do your team's ideas influence the company's direction?

The marketing team brings in and drives the voice of our customers across the organization. Each strategic decision we make at ArcherDX is informed by a deep, customer-centric approach, where we use our insights to better understand how we can deliver an exceptional experience and aim to positively impact the lives of the patients we serve!

Ali

Director, Global Marketing

What are ArcherDX Perks + Benefits

ArcherDX Benefits Overview

ArcherDX offers a competitive and generous benefit package including:

• Medical PPO or HMO and Dental-82% of monthly premium covered by the company
• Optional vision, life, FSA, dependent care plans
• Basic AD&D, Short and Long Term disability-covered 100% by the company
• 160 hours PTO per calendar after three months of service
• 6-weeks parental leave covered 100% by the company
• 401K with company match with potential of up to $2000/year
• 2019 bonus - 5% based on company objectives (for non-commissioned employees)
• Company stock options for all employees
• Tuition Reimbursement
• Ecopass

Culture
Volunteer in Local Community
Partners with Nonprofits
Friends Outside of Work
Eat Lunch Together
Daily Stand-up
Open Door Policy
Team-owned Deliverables
Team-Based Strategic Planning
Group Brainstorming Sessions
Diversity
Documented Equal Pay Policy
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Employees who have been with the company for 12 months are eligible for 12 weeks of family medical leave.
Company-Sponsored Family Events
Archer sponsors family oriented events annually. This year, we had our summer picnic at the Boulder Reservoir.
Vacation & Time Off Benefits
Generous PTO
Paid Holidays
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Cross-Functional Training Encouraged
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