Associate Director/Director of Document Quality Operations (Based in Sunny San Diego)

Location
San Diego, CA
Salary
Base plus Bonus plus Options!
Posted
Jun 13, 2018
Required Education
Bachelors Degree
Position Type
Full time

This an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of "best in class" assets across multiple therapeutic areas.

The Opportunity

The Associate Director/Director of Document Quality Operations (DQO) role is responsible for document quality checks (source vs. text/tables/figures), regulatory document template management, style guide maintenance, literature reference management system, document formatting reviews, and standard text management, when applicable. 

What you’ll dive into

  • Partnering with medical writers, subject matter experts, and other content providers to collect and organize source material for document QC prior to the scheduled QC period
  • Managing the QC schedule/queue and assigning QC resources to documents based on QC reviewer availability and task priority
  • Conducting 100% content QC against source material and style guide
  • Ensuring final Word document formatting review/repair is conducted prior to document approval in the electronic document management system
  • Maintaining regulatory submission document template suite and troubleshooting document template issues/problems encountered by template users
  • Maintaining/updating regulatory submission document style guides via periodic review with a style guide team consisting of a cross-section of functional subject matter experts
  • Updating and maintaining the reference management system; ensuring input (e.g., meta-data for each literature reference) and output (e.g., document-level auto-generated literature reference list) conforms with standards and styles; ensuring appropriate licensing for all literature references contained in document management system
  • Working with medical writing to develop and maintain standard text within templates, which may be company-wide or program specific
  • Building and maintaining positive working relationships with key stakeholders, team members, and vendors

What we expect

  • Bachelor’s degree in a medical or scientific discipline
  • 10+ years of relevant and progressive experience in a biotechnology, pharmaceutical, or other scientific company required
  • Recent and significant experience in regulatory submission document content QC, including management of QC scheduling and resourcing in a fluid environment with changing priorities
  • Experience with electronic document management administration, writing tools (e.g. Starting Point template suite), and style standards is required
  • Experience managing literature reference repository supporting regulatory submissions; understanding of copyright and licensing requirements
  • Ability and passion to work in a demanding, fluid, and fast-paced environment
  • Ability to own responsibility for document quality systems and procedures and serve as the technical expert for users and collaborators
  • Demonstrated ability to collaborate with multiple stakeholders to ensure priorities are set and timelines are met
  • Demonstrated ability to act and think strategically and see “the big picture” of the document development and submission cycle, but also be concerned with the smallest details of each individual document
  • Demonstrated ability to communicate and write English clearly, concisely, and effectively
  • Demonstrated ability to lead and drive others to meet a common goal, especially in cases when there is no formal authority
  • Travel less than 10%

What you’ll get

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
  • Opportunities to learn and contribute creative solutions
  • Comprehensive health insurance ($0 premium on select medical plans)
  • Matching 401k retirement plan
  • Paid time off and holidays
  • Company celebrations

Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at jobs@arenapharm.com.