Senior Documentation Specialist
Company: Bristol Myers Squibb
Posted on: June 12, 2021
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.
- 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
- 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
- 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
- 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
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 email@example.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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