NewBrunswickRecruiter Since 2001
the smart solution for New Brunswick jobs

Senior CMC Documentation Scientist

Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: October 7, 2019

Job Description:

This position involves coordinating filing activities, compiling information from scientists, and authoring the CMC sections of regulatory documents (e.g., IND, CTA, NDA/BLA) to support the timely submissions of both investigational and marketing applications of small and large molecules. Responsibilities also include coordinating the assembly of prompt and accurate technical responses to inquiries from the FDA and other regulatory agencies on the CMC sections of regulatory documents. These tasks will be performed in close collaboration with the following departments: Chemical & Synthetic Development, Drug Product Science and Technology, Analytical & Strategy Operations, Global Manufacturing and Supply, Drug Safety Evaluation, and Global Regulatory Sciences (GRS-CMC). A successful candidate will also be responsible for providing feedback to the Integrated Development Team on CMC issues and developing timelines for the completion of the CMC sections of regulatory documents. This position involves the critical evaluation of analytical data, knowledge of fundamental principles of organic chemistry and/or pharmaceutical sciences, and experience in drug product and/or drug substance CMC development. A successful candidate is expected to pay scrupulous attention to detail, toidentify proactively key issues, to negotiate the delivery of approved technical documents in accordance with project timelines, and to respond to CMC development opportunities. The candidate should have excellent verbal and written communication skills, as well as scientific judgement and interpersonal skills. This position requires constructive interactions with other members of a team to approach problem solving. Familiarity with computer-assisted document preparation tools is highly desirable. A Ph.D. or M.S in Pharmaceutics, Organic Chemistry, Biochemistry, or related disciplines with3-5 years of pharmaceutical development experience is preferred.

Keywords: Bristol-Myers Squibb Company, New Brunswick , Senior CMC Documentation Scientist, Other , New Brunswick, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Amazon Delivery Driver - Levittown
Description: Amazon Holiday Delivery Driver Shifts: Early Morning, Day, Evening, Weekend Location: Bethpage Job opportunities vary by location. We update postings
Company: Amazon Workforce Staffing
Location: Levittown
Posted on: 10/19/2019

Data Researcher for Cannabis Industry
Description: Mommy Jobs Online mommyjobsonline.com is now seeking Data Researchers. The client will acquire and maintain up-to-date data on over 18,000 marijuana licenses, making it the most comprehensive U.S. marijuana (more...)
Company: Mommy Jobs Online
Location: West Babylon
Posted on: 10/19/2019

Remote - Client Support Professionals
Description: Are you looking to embark on a new career with our company We have two open positions available. We are seeking multi-talented, driven individuals to serve as a benefit consultant. Our benefit consultants (more...)
Company: Career Division
Location: West Babylon
Posted on: 10/19/2019


Get New Siding Work Today - Preview Leads In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: New Brunswick
Posted on: 10/19/2019

Amazon Delivery - White Plains
Description: Amazon Holiday Delivery Driver Shifts: Early Morning, Day, Evening, Weekend Location: Bethpage Job opportunities vary by location. We update postings
Company: Amazon Workforce Staffing
Location: White Plains
Posted on: 10/19/2019

Bid On Local Remodeling Jobs - Reach New Customers In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: New Brunswick
Posted on: 10/19/2019

Amazon Holiday Delivery Driver - Hicksville
Description: Amazon Holiday Delivery Driver Shifts: Early Morning, Day, Evening, Weekend Location: Bethpage Job opportunities vary by location. We update postings
Company: Amazon Workforce Staffing
Location: Hicksville
Posted on: 10/19/2019

Risk & Compliance Co-worker (Part-Time up to 34 hours a week)
Description: br br br ul br br li br Candidate profile title br br br WHY WE WILL LOVE YOU br br br li br Candidate profile text - Default language br br br --- 1 year work (more...)
Company: Ikea
Location: Hicksville
Posted on: 10/19/2019

Amazon Delivery Driver - White Plains
Description: Amazon Holiday Delivery Driver Shifts: Early Morning, Day, Evening, Weekend Location: Bethpage Job opportunities vary by location. We update postings
Company: Amazon Workforce Staffing
Location: White Plains
Posted on: 10/19/2019

Full-Time Delivery Driver
Description: Amazon Holiday Delivery Driver Shifts: Early Morning, Day, Evening, Weekend Location: Bethpage Job opportunities vary by location. We update postings
Company: Amazon Workforce Staffing
Location: West Babylon
Posted on: 10/19/2019

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

New Brunswick RSS job feeds