- Gilead Sciences, Inc. (Parsippany, NJ)
- …programs from initial feasibility through full-scale commercialization. + Partner with global regulatory (clinical and CMC) for developing combination products ... with evolving requirements across FDA, EMA, PMDA, and other global authorities. + In concert with CMC RA...advanced degree. Regulatory Expertise: Direct experience with global regulatory submissions and agency interactions for… more
- Astrix Technology (Atlanta, GA)
- …design, development, and delivery of digital platforms supporting laboratory, clinical, regulatory affairs , and select manufacturing operations. + Ensure ... **Managing Director , Application Services** **POSITION** **Reports To:** Chief Operating...regulatory , and manufacturing environments. + Proven success scaling global teams and digital platforms in regulated industries. +… more
- Merck (Lenexa, KS)
- …marketing teams within the organization along with sales, product development, regulatory affairs , customer service, and other cross-functional teams to ... skills and ability to successfully partner cross functionally with all business units, regulatory , legal, and with Global Marketing colleagues + Demonstration of… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …PSO provide guidance to successfully deliver best-in-class secure products, consistent with global regulatory requirements over the lifecycle. This role works in ... makers of possible!** BD is one of the largest global medical technology companies in the world. _Advancing the...close partnership with R&D, Enterprise Security, Quality, Regulatory Affairs , Legal, business leaders and functional… more
- Abbott (Abbott Park, IL)
- …and clinical development. + Provide medical and scientific leadership in preparing global regulatory submissions and representing the company in regulatory ... We are seeking a highly experienced and strategic Senior Director of Medical Affairs to lead medical... Information responses. + Ensure compliance with FDA and global regulatory standards, and maintain collaborative communication… more
- Rhythm Pharmaceuticals (Boston, MA)
- …collaboratively with key inter-disciplinary stakeholders (eg biostatistics, clinical development and regulatory affairs ) to drive the generation of actionable ... Company Overview Rhythm is a global , commercial-stage biopharmaceutical company committed to transforming the...Summary We are seeking a highly motivated and experienced Director of Data Science to lead data-driven initiatives in… more
- BeOne Medicines (Emeryville, CA)
- …development. This role partners closely with Clinical Pharmacology, Clinical Biomarker, Regulatory Affairs , and Clinical Development to ensure robust study ... **General Description:** The Director of Biostatistics will provide strategic statistical leadership...design, insightful data analysis, and timely support for global regulatory submissions. Deep expertise in PK… more
- Honeywell (Atlanta, GA)
- …relevant industry standards in target markets worldwide. Work closely with legal and regulatory affairs teams to navigate complex regulatory landscapes. ... We are seeking a highly experienced and strategic Senior Director in Healthcare to lead our New Product Introduction...and the ability to drive cross-functional collaboration in a global environment. **Ideal candidate experience** + 10+ years of… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …cross-functional teams, including software development, product management, quality assurance, and regulatory affairs , to ensure alignment and a shared ... diagnostic solutions. We are seeking a visionary and experienced Director of Software Test to lead our global...understanding of quality objectives. + ** Regulatory Compliance:** Ensure that all software testing activities are… more
- Lilly (Houston, TX)
- …+ Previous experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs . **Education Requirements:** + BS in Engineering or ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more