Medical Writer – 423750

Revel IT

OUR GOAL: 
Treat our consultants and clients the way we would like others to treat us — we are honest, stay true to our word, and work in the best interest of our clients, consultants, and candidates. Many say they work this way, but few actually do. We are a company that does. Additionally, we bring joy to the world of IT staffing and IT recruiting by making the hiring experience memorable, fun, and different. 
 
OUR MISSION:
Find and provide the best talent for clients and excellent career opportunities for consultants and candidates — whom we treat as part of our team. Interested in joining our team? Check out the opportunity below and apply today!
  
Reference: 423750
  
Our Tucson, AZ client has a contract need for a LOCAL Medical Writer who will be responsible for supporting medical writing activities associated with the Clinical Science function. The individual must be able to work independently with project team members and the Biostatistics and Data Management staff to draft, edit, and finalize a variety of documents including clinical study protocols and clinical study reports for registrational studies in support of marketing applications to the Food and Drug Administration (FDA) and global product registrations.     

ESSENTIAL FUNCTIONS:

  • Collaborates with Clinical Science Leads and other project team members including Biostatistics and Data Management staff to design scientifically sound studies that provide clinical evidence in support of new In Vitro Diagnostic (IVD) products.
  • Able to represent Clinical Science at weekly project team meetings in support of one or more clinical development programs.
  • Ensures high quality documentation with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines. 


REQUIRED SKILLS:

  • Familiar with Histology and Immunohistochemistry.
  • Knowledge of scientific principles and concepts.
  • Proficient in typing, use of Adobe Acrobat Pro and Microsoft Office 2010 products including Microsoft Word, Outlook, and PowerPoint.
  • Excellent and proven leadership skills, team skills, written and oral communication skills.
  • Able to manage work on multiple projects simultaneously.
  • Possesses technical proficiency, scientific creativity, collaboration skills, and advanced technical writing skills. 
  • Able to produce reports and documents independently and evaluate the writing of others. 
  • Able to rapidly develop expertise in regulatory guidelines for in vitro diagnostic devices and the statistical basis for sensitivity, specificity and reproducibility testing required for validation. 
  • Able to rapidly develop expertise in the company’s internal document management system.
  • Bachelor of Science, with graduate coursework in molecular biology/cell biology/biochemistry or in a related field (completed AMWA, CMPP, or CMWP certification is desired as well)
  • Two years of experience in protocol development, data analysis and report writing in clinical or non-clinical studies.
  • Experience in study design and data analysis. 

Manager’s Must Haves: 

  • Sound logic and reasoning.
  • Solid understanding of the scientific method and how to design an experiment. 
  • Ability to write clearly and concisely.
  • Proficient Keyboarding.
  • Interacts well with others.
  • Capable of working independently.
  • Exercises good judgement and decision making.

PREFERRED:

  • PhD preferred.
  • Prior experience with EndNote and Microsoft Visio preferred. 
  • Experience in regulatory writing is preferred.
  • Experience in design control processes is preferred.
  • Experience with approval of in vitro diagnostic devices is preferred.
  • Oncology experience is preferred.

  
  
ABOUT REVEL IT:
Revel IT (formerly known as Fast Switch) is one of the fastest-growing, privately held, IT Staffing companies in the nation. Our client base includes 32% of the Fortune 25. We have major offices in Dublin, OH, Tucson, AZ, Los Angeles, CA, and Austin, TX and are rapidly expanding into new markets from coast to coast.
 
  
WHY REVEL IT: 

  • In addition to standard health and 401k benefits, we offer referral bonuses and training/continuing education opportunities.
  • 5-year client retention: 99%
  • No. 1 supplier with customers: 53%
  • Top 3 supplier with customers: 77%
  • Consultant retention: 94%

  
We do our jobs in a way that brings delight every day to our clients and the people who work with us. Life is simply too short to grind through every day as a small cog in a huge recruiting machine. As a young and high energy company, we aim to help consultants and candidates land fulfilling jobs that offer real career growth.
  
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