Bristol-Myers Squibb Company

CMC Document Specialist

Location
New Brunswick, NJ, US
Posted
Jul 05, 2018
Ref
R1506812
Required Education
Bachelors Degree
Position Type
Full time
The CMC Document Specialist supports the documentation activities for regulatory submissions for biologic products as part of the CMC Strategies team. The CMC group is committed to supporting the biologics network with integrity, reliability, active engagement and cross-functional collaboration.
This role requires effective collaboration across technical functions to deliver on timelines for submissions. The position routinely interfaces with experts in Process Development, Manufacturing Sciences and Technology, Operations, Analytical Science and Technology, Quality and Regulatory Sciences. The successful candidate will work effectively in cross-functional project teams to accomplish company goals.

Responsibilities:
  • Support the logistical process for regulatory submissions including pre and post submissions while interfacing across the BMS network.
  • Assist with dossier creation and system compliance for regulatory submissions.
  • Assist in the facilitation of authoring, review, verification and submission-ready compliance for the finalization of filings.
  • Participate in initiatives involved with regulatory filings.
  • Participation on various cross-functional project teams, interactions with Technical operations and regulatory staff at different BMS sites and other key partners both internal and external to the company are necessary.
  • Must possess the ability to support multiple projects.
  • Work in a team environment and foster teambuilding for the improvement of processes and enhancement of productivity to align with key business drivers.
  • Demonstrate commitment to excellence and bring a high energy level to daily activities as well as involve periods of high intensity work under tight timelines.
  • Works under supervision and collaborates with other groups.


Qualifications:
  • Bachelor's degree with 0-2 years of direct pharmaceutical work experience. Advanced degree is an asset.
  • Excellent organizational, communication and time management skills are required along with proficient navigation of electronic systems.
  • Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines and ensuring the most efficient regulatory process.
  • Possess strong interpersonal skills and demonstrates ability to effectively interact with business functions.