What are the responsibilities and job description for the CMC Technical Documentation Specialist position at Dexian?
Title – CMC Technical Documentation Specialist
Months- 6 Months (potential extension)
Location- New Brunswick, NJ (hybrid)
Pay Range- $35-41/hr. on W2
Job Description:
This position involves compiling information from scientists, authoring the chemistry, manufacturing, and controls (CMC) sections of regulatory documents, and performing data integrity checks to support the timely submissions of both investigational and marketing applications for small and large molecules. This position requires the knowledge of fundamental principles of organic chemistry, the critical evaluation of analytical data, and it is preferred to have experience in drug substance and/or drug product CMC development.
Job Qualifications:
The candidate should have excellent verbal and written communication skills and is expected to pay scrupulous attention to detail. This position requires constructive interactions with other members of a team to approach problem solving. Familiarity with computer-assisted document preparation tools is desirable.
Education:
Required B.S. in Chemistry. M.S. or Ph.D. in Organic or Medicinal Chemistry is strongly preferred
Skills:
Regulatory Documentation and/or Authoring experience (not just formatting)
Multitasking ability
Strong communication -oral and written
Pharmaceutical background
Strong organic or Medicinal chemistry
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
Salary : $35 - $41
