CTG CMC Documentation Specialist in Morristown, New Jersey
Title: CMC Documentation Specialist
Job Number: 18205077
CMC Documentation Specialist
CTG's premier global pharmaceutical client located in Morristown, NJ has an immediate need for a CMC Documentation Specialist. 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.
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.
Duties and Responsibilities:
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
Educational Requirements / Qualifications:
Bachelor Degree or some college preferred, or a High School Diploma with a solid base of relative experience
1-2 years’ experience in FDA-regulated industry, preferably a consumer products company
Excellent in Word, Excel, PowerPoint, Adobe Acrobat
Strong organization and management skills
Excellent writing (data entry) and oral communication skills
Proficient in regulatory and change management systems (ie. Documentum, Trackwise)
Fluent in English Required
Fluency in German and/or French highly preferred
Pay Range: $25.00 - $30.00 per hour W-2 only (sorry no Corp to Corp)
Duration: 12 Months, extendable
Shift: 8:00 AM Start
APPLY NOW for resume review by Mary Jane “MJ” Slaughter or email email@example.com. Please reference CTG Job #18205077. Referrals are greatly appreciated!!
CTG’s Benefits Plan allows you to select insurance coverage that best suits your lifestyle, and take part in our savings programs and educational plans. We offer Flexible Spending Accounts, a 401(k) Retirement Plan, and an Employee Stock Purchase plan. Our educational plan comprises access to more than 2,000 web-based technical, professional and business development courses.
CTG (NASDAQ: CTG) provides industry-specific IT services and solutions that address the business needs and challenges of clients in high-growth industries in North America and Western Europe. CTG also provides strategic staffing services for major technology companies and large corporations. Backed by more than 50 years of experience and proprietary methodologies, CTG has a proven track record of reliably delivering high-value, industry-specific staffing services and solutions to its clients. CTG has operations in North America, Western Europe, and India.
CTG's greatest asset is its people, and as such, we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work in Healthcare company by Modern Healthcare (2013-2016) in North America, and a Best Workplace in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011).
CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.
CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.
Job: Document / Print Management