Job added in hotlist
Applied job
Contract job
90-day-old-job
part-time-job
Recruiter job
Employer job
Expanded search
Apply online not available
Similar Jobs
Project Manager
Sigma Systems Inc.
Ridgefield, NJ
Apply Now >
Research Technician, Sr
Memorial Sloan Kettering Cancer Center
New York City, NY
Apply Now >
QC Chemist
North Brunswick, NJ
Apply Now >
Lab Extraction Engineer (Cannabis)
Franklin, NJ
Apply Now >
Site Project Engineer
Hackettstown, NJ
Apply Now >
View more jobs in Madison, NJ
View more jobs in New Jersey

Job Details

Clinical Technical Writer

Location
Madison, NJ, United States

Posted on
Jul 12,2019

Apply for this job






Profile

Clinical Technical Writer needs 2 years' experience in Regulatory Affairs experience Clinical Technical Writer requires: Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline 2 years of experience in pharmaceutical research and development or regulatory affairs 1 years of CMC regulatory experience is desirable Prior experience in the preparation of CMC sections of regulatory dossiers including electronic submissions Strong working knowledge of manufacturing unit operations Familiarity with US and other international regulatory requirements for drug product dossier Clinical Technical Writer duties: Prepare, coordinate, and manage the chemistry, manufacturing, and control (CMC) documents for annual reports (IND and NDA). With supervision prepare CMC documents for use in routine US and ex-US regulatory filings. Provide guidance on use of submission document templates. Provide assistance on department related assignments and projects. Identify and communicate routine CMC issues. Collaborate with diverse functional groups to ensure fileability and acceptance

Company info

Sign Up Now - ChemistryCrossing.com

Similar Jobs:
R&D Product Developer IV
Location : East Hanover, NJ
This position is for an experienced technical Product Developer who will lead and execute productivity projects within the Global Biscuit Treat Productivity Platforms group. The Candidate will be responsible for the development, o...
Biochemical Technologist
Location : New York City, NY
Save Education Bachelor's Degree Skills Time Management DNA Isolation Next Generation Sequencing Molecular Biology Sema4 is a patient-centered predictive health company founded on the idea that more data, deeper analysis, and incr...
Manufacturing Chemical Engineer
Location : Oakland, NJ
Position Responsibilities: Perform root-cause analysis on manufacturing process issues and determine cause for lot failures Gather and analyze laboratory data on manufacturing lots produced and perform statistical analysis and...