- Sumitomo Pharma (Sacramento, CA)
- …for the Prostate Cancer therapeutic area and set the strategy for both internal company programs and external facing interactions. This job will effectively lead and ... Provide strategy and oversight for the development of a supportive US Investigator Initiated Study and Collaborative Research program. + Provide detailed and… more
- AbbVie (Irvine, CA)
- …analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and ... clinical development, coordinating appropriate scientific and medical activities with internal stakeholders. May participate in due diligence or other business… more
- System One (Alameda, CA)
- …CMC, Toxicology, Clinical Development and Regulatory to deliver on project and corporate objectives + Prepare high quality regulatory documents including IND, CTA, ... and clinical study protocols, nonclinical and clinical study reports, and investigator brochures + Support functional area reviews for due diligence evaluations… more
- Merck (San Diego, CA)
- …+ Worldwide marketing applications + Clinical study protocols and reports + Investigator brochures + Local registration study protocols for secondary markets + ... Represent Global Regulatory Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD) to provide...building and leading high performing teams or projects; exemplifies corporate and ethical integrity; drives success consistent with company… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka ... clinical pharmacology documents for regulatory filings including annual reports, investigator 's brochure, IND/NDA applications and pediatrics development plans. +… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …Global CNS evidence generation with Phase IIIB and IV studies, including Investigator Sponsored Studies and non-interventional studies + Develops and provides CNS TA ... function operates effectively and efficiently Ensures compliance with all relevant Corporate Policies (CO) and Standard Operating Procedures (SOPs). + Ensures… more