- Gilead Sciences, Inc. (CA)
- … project planning and/or project management + Strong understanding/experience in clinical and/or pre- clinical research , or experience in Clinical ... analyses, regulatory submission support and contract negotiations + Ensure clinical demand accuracy, clinical logistics preparation and Tech Ops readiness… more
- Pfizer (South San Francisco, CA)
- …the product lifecycle and a regulatory representative to marketing, commercialization, research project teams and government regulatory agencies. Your ... tasks. You will play the critical role of providing regulatory strategic direction to teams overseeing clinical ...products. Through your expertise, you will be the diagnostic regulatory liaison on the project team throughout… more
- AbbVie (Irvine, CA)
- …nonclinical and clinical pharmacology/PKPD and biomarker scientists, safety scientists, research scientists, clinicians and project teams. + Design and ... leads the strategy, generation, analyses, interpretations, and reporting of non- clinical data and communications/agreements with global regulatory agencies… more
- Abbott (Santa Clara, CA)
- …based upon regulatory changes + Support pre and post approval clinical strategy and submission activities + Anticipate regulatory obstacles and emerging ... with US and global product post marketing approval requirements + Evaluate proposed clinical and manufacturing changes for regulatory filing strategies + Execute… more
- Cedars-Sinai (Beverly Hills, CA)
- …presents an exciting opportunity for individuals interested in beginning a career in clinical research . It offers the chance to work collaboratively with ... success in the field. Whether pursuing a future in clinical research , laboratory science, or healthcare, this...Performs administrative duties in laboratory or in accordance with research project . + Maintains project … more
- Abbott (Pleasanton, CA)
- …international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory ... diabetes from routine fingersticks. **WHAT YOU'LL DO** We are recruiting for a ** Regulatory Affairs Specialist II** to join our team in the Pleasanton, CA location.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …or other programs. You will lead Regulatory Submission Teams or other Regulatory Project Teams and represent Global Therapeutic Area Regulatory on ... and help create possible, together. **Job Description** As an Associate Director, Global Regulatory Affairs, you will act as the Regional Regulatory Lead on… more
- Bausch + Lomb (Sacramento, CA)
- …mentor individuals on subject matter expertise + Provide guidance and direction regarding regulatory strategy to project teams + Participate in assigned due ... US and/or Canada + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical /non- clinical...external regulatory stakeholders and shape the external regulatory environment. + Advanced Project Management /… more
- Pfizer (South San Francisco, CA)
- …with key internal and external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human ... clinical teams with Pfizer development operations and the project team, to meet enrollment and study delivery timelines....among teams and therapeutic areas. + Coordinate with other clinical research activities within Oncology Research… more
- Lilly (San Diego, CA)
- …health authority meeting experience + Advanced degree or fellowship training in clinical research or pharmaceutical medicine + Experience with innovative, ... studies that efficiently test therapeutic hypotheses + Collaborate with clinical pharmacology, biostatistics, regulatory affairs, operations, and other… more
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