Senior Scientific Writer I

Bristol Myers Squibb EU Policy · Shanghai, VA · 3 days ago

WritingFull-time

for Clinical Study Reports (CSR), briefing documents, Common Technical Document (CTD) summary documents, responses to Health Authority queries
for timely submission to China health authorities according to: good documentation principles (organization, clarity, scientific standards)
consistency between text and tabular presentations or graphical displays
in compliance with BMS documentation standards and worldwide regulatory requirements

including messaging, document flow, logic, and consistency for assigned projects

Comply with internal and external processes and guidelines
manage the review process
on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members
ensure optimal communication between authoring team and development team members
coordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation
timely completion and high quality of assigned documents

serve as a liaison for external documentation support (when required)
prepare specifications for the work
ensure maintenance of good documentation principles as well as BMS documentation standards

Lead and influence a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship
be bold in exploring innovative approaches and methods for medical writing

BMS Has An Occupancy Structure That Determines Where An Employee Is Required To Conduct Their Work.
This Structure Includes Site-essential, Site-by-design, Field-based And Remote-by-design Jobs.
The Occupancy Type That You Are Assigned Is Determined By The Nature And Responsibilities Of Your Role:
Site-essential roles require 100% of shifts onsite at your assigned facility.
Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.
For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.
Field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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