Documentation Specialist

New
  • Location
    Morristown, New Jersey
  • Job type
    Contract/Temporary
  • Category
    Medical & Science - Therapist

Adecco is currently assisting a local client in their search to fill an exciting Documentation Specialist role in Morristown, NJ! Apply now if you meet the qualifications listed below!



DESCRIPTION
POSITION/TITLE: Documentation Specialist
RATES: negotiable based on experience
DEPARTMENT/TEAM
The CMC Documentation Team is responsible for the development of Chemistry, Manufacturing and Control (Module 3) documentation for the commercial products in the company's portfolio.

POSITION SUMMARY
Under the broad guidance of the CMC product leads, the job entails supporting the CMC Documentation team in the preparation of CMC registration documents. The person will be responsible for the creation and maintenance of regulatory CMC documents in the controlled document management system.

POSITION DUTIES & RESPONSIBILITIES
The primary job duties and responsibilities may include the following.
• Document conversions (PDF and Excel) into Word files
• Proof reading of documents for accuracy
• Loading of documents into regulatory systems
• Loading of documents into department databases
• Maintain timeline of projects and status updates
• Maintain team meeting minutes


REQUIREMENTS/PREFERENCES
Education Requirement(s):
• High School Diploma

Skill & Competency Requirements:

• Fluent in English
• Excellent in Word, Excel, PowerPoint, Adobe Acrobat

• Strong organization and management skills
• Excellent writing (data entry) and oral communication skills

Preferences:

• BA/BS
• Proficient in regulatory and change management systems (ie. Documentum, Trackwise)
• 1-2 years’ experience in FDA-regulated industry, preferably a consumer products company
• Fluent in German and/or French

  • Apply with Adecco

Reference number US_EN_2_022862_403665