- AbbVie (North Chicago, IL)
- …to ensure clinical data is robust, accurate, and usable for regulatory submissions, evidence generation, and advancing clinical development objectives. There ... clinical development, quality assurance, technology, data management, and regulatory affairs. + Study Management Associate Organization: The Study Management… more
- Community Health Systems (Franklin, TN)
- …practice, clinical guidelines, and organizational priorities. Working closely with clinical , quality, safety, and regulatory leaders, the Director translates ... **Summary** The Director of Clinical Education & Development, under the direction of...based on identified needs from quality, safety, compliance, and regulatory teams. + Translate evidence-based guidelines, policies, and emerging… more
- AbbVie (North Chicago, IL)
- …to ensure clinical data is robust, accurate, and usable for regulatory submissions, evidence generation, and advancing clinical development objectives. There ... clinical development, quality assurance, technology, data management, and regulatory affairs. + Study Management Associate Organization: The Study Management… more
- BeOne Medicines (Emeryville, CA)
- …and assess the impact to applicable safety documents or safety section of clinical or regulatory documents. + Lead strategy development, analysis, and response ... effective execution, communication and influence with internal stakeholders (eg, clinical development, medical, regulatory , labeling) and external stakeholders… more
- Sanofi Group (Morristown, NJ)
- …clinical modules for registration dossier, including overall EU or US clinical regulatory documentation using available standards, and ensure consistency ... who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead.… more
- Astellas Pharma (Cambridge, MA)
- …across Oncology and Biopharma/Cell&Gene and with senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and Pharmacovigilance/Medical Safety ... **Head of Solid Tumor Clinical Development** Do you want to be part...-Play a strategic lead role, in collaboration with Research, Regulatory Affairs and Early Development and Translational Sciences, to… more
- Stryker (Jersey City, NJ)
- …+ Supports Clinical Research team, sometimes serving as the Clinical representative, interactions with regulatory authorities, notified bodies and during ... The **Senior Clinical Project Manager (Remote)** assists in global ...and integrity of data, compliance with relevant SOPs and regulatory requirements and completes studies on-time and on-budget. **What… more
- Takeda Pharmaceuticals (Boston, MA)
- …study protocols, strategy slide decks, statistical analysis plans, briefing packages, clinical study reports, and regulatory labelling interactions. Ensure these ... innovative therapies across the oncology portfolio through: + Analysis of unmet clinical need and potential therapeutic preferences + Development of Clinical … more
- ManpowerGroup (Merrimack, NH)
- …to work independently in a fully remote setting + Familiarity with clinical trial documentation and regulatory requirements; prior experience with monitoring ... supporting innovative medical solutions + Gain valuable experience in clinical trial management and regulatory compliance +...valuable experience in clinical trial management and regulatory compliance + Work in a supportive and inclusive… more
- Bristol Myers Squibb (Cambridge, MA)
- …advisory board meetings as Senior Clinical Trial Physician + Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission ... work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Clinical Trial Physician sits within Clinical Development, which is a… more