- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Director May… more
- Otsuka America Pharmaceutical Inc. (Santa Fe, NM)
- …including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides ... with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD...programs after proof of concept through late-stage trials and regulatory submissions. + Provide medical and scientific … more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director, Regulatory Affairs Global Regulatory Strategy is responsible ... in or lead regulatory and company initiatives. Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for GRPT… more
- Merck (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior … more
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Director for Milvexian Global Medical Strategy will provide deep disease ... IIIb/IV trials and real-world evidence programs across Global Medical Affairs + Review and develop study concepts, protocols and...to questions in response to issues relative to commercial, scientific , or data needs + Serves as medical strategy… more
- Sanofi Group (Waltham, MA)
- …activities (when applicable), including quality, relevance to external stakeholders (eg regulatory authorities, medical journals), and scientific validity. We ... **Job Title:** Senior Project Biostatistics Lead- Vaccines **Location:** Waltham, MA...+ Contribute with project team members (ie: clinical, pharmacovigilance, regulatory , ) to gain Health Authorities acceptance of the… more
- Sanofi Group (Cambridge, MA)
- …organization and priorities and 3) trends in environment and competition + The Senior COA Lead actively participates in the regulatory and commercial dynamic ... instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research...guidance and support to the COA scientists. + The Senior COA Lead is accountable for scientific … more
- Mondelez International (East Hanover, NJ)
- …in North America (NA), inspiring product renovations and innovations. Working with regulatory and scientific affairs , marketing, consumer insights, nutrition ... and public health and partnering with key functions like scientific affairs and corporate and government ...in a clear, concise, and compelling manner + Influencing senior , cross-functional partners and external bodies + Managing and… more
- Edwards Lifesciences (Phoenix, AZ)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- System One (Cleveland, OH)
- …related scientific discipline + Minimum of 6+ years of pharmaceutical regulatory medical writing and 3+ years of scientific /academic writing experience, and ... Job Title: Director / Senior Director Medical Writer Location: CST or EST...responsible for document creation across clinical development and medical affairs . It is expected this will include the successful… more