Document Specialist

Simulations Plus is a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry. Our biosimulation solutions integrate artificial intelligence/machine learning, physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling.  

We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide. 

Leadership truly cares about maintaining a positive culture and employee well-being. We offer fully remote work, flexible schedules, and generous vacation policy along with affordable health coverage, stock options, annual bonuses, and more! 

The Document Specialist will perform a wide range of activities with high-level direction from management including assisting in preparing deliverables, creating and maintaining company templates, supporting colleagues, and advising and consulting with clients on assigned projects. 

Business Unit: Shared Services

Department: Operations

Internal Grade: 3

Direct Reports: No

Status: Non-Exempt

Location: Remote 

Job Responsibilities: 

• Provide word processing support and assist in the assembly of reports, posters, and presentations, while following guidance from the project leader and ensuring appropriate templates, style guides, and standard operating procedures are followed
  • Attend project team meetings
  • Transcribe material from dictation or notes
  • Correct common errors prior to formal proofreading
  • Answer questions about appropriate templates and style guides
  • Assist with article retrieval
• Assure appropriate documents have been electronically filed at project close
• Create and maintain company templates for deliverables using appropriate software packages
• Recommend improvements to existing templates or the need for the creation of new templates
• Create and maintain training records and professional summaries for the assigned Business Unit
• Act as Document Management Center Dedicated Archivist designate for the assigned Business Unit
• Create and maintain spreadsheets and databases
• Assist in coordinating and arranging external travel, verify travel receipts, and complete reimbursement forms for the assigned Business Unit
• Provide requested meeting materials and arrangements for assigned projects, including venue, food service, agendas, and other materials for the assigned Business Unit
• Develop rapport with clients for assigned projects
• Follow project timelines for deliverable tasks, track time spent on projects, and inform the project leader and Project Management of any changes that will cause additional time to be spent on a project
• Retrieve reference materials and enter the required information for new and existing references into appropriate database
• Assist in writing clear and concise job-specific Quality Management System documents
• Assist with Quality Management System documents (e.g., Policies, Standard Operating Procedures, Work Instructions, etc.)
• Identify and explore opportunities for professional development and training
  • Attend internal and external training opportunities 
  • Remain current with professional reading
  • Provide internal training based upon direction from more senior colleagues
• Track time spent on various projects using electronic time-control system
• Comply with policies and standard operating procedures, as specified by the company Quality Management System
• Other duties as assigned 

Qualifications: 

• 5+ years of administrative-related business experience
• Strong computer skills using MS Office Suite
• Ability to operate standard office equipment
• Job related experience using AI or GenAI required 
• Basic understanding of medical terminology 
• Demonstrated customer support skills
• Strong client-facing, written, and verbal communication skills
• Excellent organizational skills including attention to detail and multitasking abilities
• Strong interpersonal and time management skills
• Flexible and works well under pressure
• Ability to work in a fast-paced, deadline-driven environment
• High energy and passionate personality
• Maintains a positive attitude while interacting with colleagues and clients
• Self-motivated with the ability to work with minimal supervision
• Occasional travel for meetings and trainings 

Education: 

• Associate’s degree in administrative, business, or related field
• Bachelor’s degree in administration, business, or related field a plus

Find out more about how amazing it is to work at Simulations Plus by visiting www.simulations-plus.com/career-center and apply today!