- Sumitomo Pharma (Lincoln, NE)
- …and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and ... Manager of Regulatory Operations is responsible for managing all Regulatory Affairs activities involving compilation, publishing , distribution, and archiving… 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 (Spring House, PA)
- …within and across TAs independently. + Contributes to and champions internal standards, regulatory , and publishing guidelines. + Contributes to and champions the ... are searching for the best talent for Associate Director, Regulatory Medical Writing - Oncology.** **Purpose:** + Able to...+ Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead role in… more
- J&J Family of Companies (Spring House, PA)
- …contributing to and championing Medical Writing process improvements, internal standards, regulatory , and publishing guidelines, internal systems, tools, and ... searching for the best talent for an **Associate Director, Regulatory Medical Writing** within our Integrated Data Analytics &...or more of our therapeutic areas within the X-TA Regulatory Medical Writing area. This position is open globally… 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 (Frankfort, KY)
- …to ask questions + Ideally targeting 2+ years of professional experience (background in publishing , editing, or regulatory a plus but not required) **_What is ... to making a difference for our customers and communities. **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions… more
- Takeda Pharmaceuticals (Boston, MA)
- …to evaluate the impact of regulatory updates on data, coordinating with regulatory teams (eg, submission publishing , CMC, drug labeling, compliance, and IT) ... opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director, Regulatory Data Governance Lead **POSITION DESCRIPTION** : Takeda Development Center… more
- Vera Therapeutics (Brisbane, CA)
- …for briefing documents and agency meetings. * Coordinate submission scheduling with regulatory publishing and ensure delivery of high-quality documents. * May ... our lead late-stage development Program, Atacicept, in alignment with Vera's Regulatory strategy and our commitment to health authorities globally. Responsibilities:… 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 (Irvine, 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
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