- AbbVie (Jersey City, NJ)
- …The Senior Statistical Analyst interfaces with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations. + Leads the statistical ... sets for individual studies and integrated data. + Create documentation for regulatory filings including reviewers guides and data definition documents + Leads the… more
- AbbVie (North Chicago, IL)
- …and/or late stage development, interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing & Clinical Operations. + Develop & oversee ... years utilizing SAS programming concepts & techniques related to drug development & regulatory filings; (ii) 5 years applying CDISC standards, including ADaM & Study… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global Development Technologies (CTMS, EDC, eTMF, IRT, eCOA, DCT solutions). Regulatory Affairs Technologies (RIM systems, publishing tools, global submission ... **Objective / Purpose:** The Head of Design & Delivery, Development & Regulatory will lead the global technical product strategy across Takeda's development… more
- RELX INC (Boca Raton, FL)
- …of choice About the business LexisNexis Legal & Professional(R) provides legal, regulatory , and business information and analytics that help customers increase their ... productivity, improve decision-making, achieve better outcomes, and advance the rule of law around the world. As a digital pioneer, the company was the first to bring legal and business information online with its Lexis(R) and Nexis(R) services. Salary range… more
- AbbVie (South San Francisco, CA)
- …in the lab + Write technical publications, reports, presentations, and regulatory filings including publishing research in peer-reviewed journals and ... written records + Proven record of authoring publications, technical reports, regulatory documents, and/or presentations + Has strong communication skills including… more
- Robert Half Legal (El Segundo, CA)
- …is partnering with an international video game company in their search for a Regulatory and Transactions Counsel to support their team on a long-term contract. This ... with a collegial in-house legal team and focus on Commercial Contracts and Regulatory Matters. This position is fully remote and requires being licensed to practice… more
- Integra LifeSciences (Princeton, NJ)
- …to advance patient outcomes and set new standards of care. The regulatory operations specialist position provides support across multiple functional areas, including ... regulatory intelligence, device establishment registration and listing (FURLS), global...registration and listing (FURLS), global unique device identification (UDI), publishing , and translations. The role also involves proficient use… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Become a **maker of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist, you will play a crucial role in supporting Medication Management ... associated software, and accessories on a global scale. **Responsibilities** + Support regulatory efforts to comply with new and existing US and international… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Lead, Regulatory Data **Location** : Cambridge, MA, Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The race is on to ... quality excellence and digital expertise with pharmaceutical and biotechnology regulatory knowledge to drive strategic projects. This position will prioritize… more
- Terumo Neuro (Aliso Viejo, CA)
- **12814BR** **Title:** Sr. Specialist, Regulatory Affairs **Job Description:** Responsible for preparing strategy for worldwide product approval submission ... focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices. Job duties: +… more
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