- Takeda Pharmaceuticals (Boston, MA)
- …and process are required. + Knowledge and experience of industry standard Regulatory publishing and Information Management tools is desired. + Generally, ... immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Operations, Compliance & Process Excellence is accountable for overseeing… more
- Medtronic (Mounds View, MN)
- …** Regulatory Operations Manager** leads a team responsible for regulatory submission publishing , product lifecycle management, master data administration, ... ** Regulatory Operations** : + Oversee the preparation, compilation, and publishing of regulatory submissions, including license renewals and annual… more
- System One (Florham Park, NJ)
- …to ensure compliance with applicable laws and regulations. This includes publishing regulatory documents, managing document tracking and version control, ... Qualifications + Minimum of 1-2 years of experience required within a pharmaceutical regulatory environment, including eCTD publishing of INDs and NDAs. Prior… more
- J&J Family of Companies (Titusville, NJ)
- …contributing to and championing Medical Writing process improvements, internal standards, regulatory , and publishing guidelines, internal systems, tools, and ... United States of America **Job Description:** **Senior Manager/Associate Director, Regulatory Medical Writing X-TA** At Johnson & Johnson Innovative Medicine,… more
- BeOne Medicines (Emeryville, CA)
- …bonus. . eCTD Validator software experience (eg Lorenz, EURS is Yours) . Regulatory Submission Publishing experience required . Document management systems (eg ... **General** **Description:** This position resides in the Global Regulatory Operations Strategy & Innovation and will interact at all levels, including BeOne's… more
- Teva Pharmaceuticals (West Chester, PA)
- …and program level Preferred: + 2 Years of experience related to clinical document publishing or regulatory submission publishing + 2 Years of experience ... to make a difference with. **The opportunity** A Clinical Publisher in Global Regulatory Medical Writing (GRMW) Operations provides basic support to GRMW (and other… more
- Cardinal Health (Jackson, MS)
- …to ask questions + Ideally targeting 2+ years of professional experience (background in publishing , editing, or regulatory a plus but not required) **_What is ... **_What Regulatory Submissions Operations contributes to Cardinal Health_** ...documents used in submissions + Process client documents within publishing software + Identify concerns and communicate with upstream… more
- AbbVie (South San Francisco, CA)
- …role must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations. Responsibilities + Leads the ... sets for individual studies and integrated data. + Creates documentation for regulatory filings including reviewers guides and data definition documents. + Leads the… more
- AbbVie (North Chicago, IL)
- …role must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations. Responsibilities + Manages a ... sets for individual studies and integrated data. + Creates documentation for regulatory filings including reviewers guides and data definition documents. + Leads the… more
- AbbVie (South San Francisco, CA)
- …Programming must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations. Responsibilities + Leads ... sets for individual studies and integrated data. + Creates documentation for regulatory filings including reviewers guides and data definition documents. + Leads the… more