Author Jobs in North Chicago
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Search Results - Author Jobs in North Chicago
AbbVie-North Chicago
into research or development programs.
Description:
Contribute to clinical development by supporting Phase 1-4 studies including study design, and clinical pharmacology strategy.
Author regulatory documents including protocols, study reports, population PK...
resume-library.com -
US Tech Solutions-North Chicago
with all functional departments in support of regulatory filings.
• Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal...
mindmatch.ai -
AbbVie-North Chicago
the accountability and scope.
Author and coordinate submission documentation for all phases of clinical development, with emphasis on later phase programs and marketing applications, often under significant time pressure. Drive team resolution and author responses...
resume-library.com -
Randstad-North Chicago
of regulatory business systems within the group.
• Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight...
randstadusa.com -
AbbVie-North Chicago
by providing necessary context (including explaining MoA and disease specifics, available relevant internal and external data, analysis plans, interpretation and discussion of model results in the context of research question).
Author regulatory documents...
resume-library.com -
AbbVie-North Chicago
by providing necessary context (including explaining MoA and disease specifics, available relevant internal and external data, analysis plans, interpretation and discussion of model results in the context of research question).
Author regulatory documents...
resume-library.com -
AbbVie-North Chicago
and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.
A primary author of publications and presentations.
Understand and adhere to corporate standards regarding applicable Corporate...
resume-library.com -
AbbVie-North Chicago
independently and providing technical support to a project team.
Provide individual technical support of all scale-up activities and maintain timelines for on-going projects.
Write/co-author process memos and scientific reports in support of Regulatory...
resume-library.com -
Katalyst Healthcares & Life Sciences-North Chicago
Responsibilities:
Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight.
Manage assigned projects...
resume-library.com -
AbbVie-North Chicago
framework to solving problems within scientific discipline in a timely manner.
Authoring of comprehensive, scientifically sound reports, e.g. development reports or risk assessments that serve as source documents for regulatory submissions. Author portions...
resume-library.com -
AbbVie-North Chicago
and adherence with FDA, USDA and GLP regulations.
Author toxicology and safety pharmacology of INDs, NDAs, BLAs, and IBs for worldwide regulatory submissions. Coordinate and review technical responses to regulatory questions.
Participate in due diligence...
resume-library.com -
AbbVie-North Chicago
others of any incidents/events which may impact AbbVie’s people assets, products, and reputation.
Responsibilities:
Author strategic intelligence assessments and reports that represent potential impact to AbbVie personnel, assets, and reputation...
resume-library.com -
AbbVie-North Chicago
technical support of all scale-up activities and maintain timelines for on-going projects.
Write/co-author/review/approve process memos and scientific reports in support of Regulatory Submissions, Regulatory Field Alerts and supportive quality control...
resume-library.com -
AbbVie-North Chicago
them to scalable processes.
Proactively advise and share knowledge and expert opinions with subordinates, peers, and senior management. Mentor staff in troubleshooting strategic and experimental issues.
Author and review key regulatory documents...
resume-library.com -
AbbVie-North Chicago
for leading the strategy for periodic reports (DSURs, PSURs, PADERs etc.)
Responsible for implementing risk management strategies for assigned products
Proactively engaging, inspiring, coaching and mentoring team and colleagues
Opportunities to co-author...
resume-library.com -
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