Bristol-Myers Squibb Company

CMC Documentation Specialist

New Brunswick, NJ, US
May 25, 2018
Required Education
Bachelors Degree
Position Type
Full time

The selected candidate will provide PRISM/CARA support for the CMC group, which includes SRC specialists role supporting CARA authoring ensuring documents are PRISM compliant, create and maintain model document templates for analytical and stability functions. Maintain the CMC & Stability group and Development Specification Committee (DSC) Share Point sites and manage the specification routing and approval for drug substance, drug product, excipient and packaging component. System administrator for QUMAS, PDDR, and Trackwise change control notification to support ASO (NBR and Moreton sites). In addition this position involves coordinating filing activities, compiling information and authoring certain CMC sections of regulatory documents (e.g., IND, CTA) to support the timely submissions of investigational filing of small and large molecules.

Position Requirements:

BS in Biology, Science, Mathematics or related field with a minimum of 2 years of experience
Strong Microsoft skills in word and excel. Experience with Core template preferred.
Experience authoring with templates, tables and graphics.
An understanding and knowledge of pharmaceutics, the development process, and regulatory guidelines.
Experience in data analysis.
Ability to manage multiple projects simultaneously and to plan and deliver the required documents on the due dates
Works independently in a team setting and is flexible in a changing environment.
Demonstration of good interpersonal skills, including good communication with supervisors and co-workers.
The candidate should have excellent verbal and written communication skills, as well as scientific judgement and interpersonal skills.