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Senior Documentation Specialist

Company: Bristol Myers Squibb
Location: Princeton
Posted on: June 12, 2021

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Responsibilities:

  • Independently collaborate with internal and external authors for EDMS (PRISM/CARA) structure assembly and facilitate document publishing of submission documents.
  • Mentor, train and provide troubleshooting assistance to internal and external authors in PRISM/CARA, Core Template, submission readiness formatting and publishing work processes.
  • Collaborate with cross-function business partners providing direction in submission readiness formatting and publishing of submission related documents
  • Lead cross-functional business partners in defining submission-ready requirements for externally authored regulatory documents. Independently manage submission readiness remediation, PRISM/CARA import and publishing of externally authored Word and PDF files.
  • Independently manage collection and review of ICH non-data driven appendices for CSRs. Direct cross-functional business partners in defining submission-ready requirements for ICH non-data driven appendices.
  • Independently coordinate, compile and/or author select submission documents types ensuring integration of scientific and regulatory input from team members.

Qualifications & Experience:

  • Minimum of BS/BA degree with approximately 2-4 years of regulatory documentation experience in document management repositories, submission readiness formatting and publishing workflows.
  • In-depth understanding of desktop applications, word template macros, model documents and submission readiness formatting for creation of eCTD compliant regulatory documents.
  • In-depth understanding of Acrobat and ISI toolbox usage in creation and remediation of eCTD compliant regulatory documents.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Keywords: Bristol Myers Squibb, Trenton , Senior Documentation Specialist, Other , Princeton, New Jersey

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