- J&J Family of Companies (Titusville, NJ)
- …for protocol design and for final protocols, clinical study reports, and clinical components of regulatory packages/submissions. He or she may delegate some ... DAS lead and with functional partners from global medical affairs , health care compliance, legal regulatory , and...and spoken English + Experience and knowledge of Good Clinical Practices and regulatory requirements for the… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …in collaboration with cross-functional teams such as Marketing, Operations, Finance, Regulatory Affairs , Quality Assurance, Medical & Scientific Affairs ... or franchises through strong collaboration with sales, marketing, operations, finance, regulatory affairs , quality assurance, medical/scientific affairs ,… more
- Penn Medicine (Philadelphia, PA)
- …Health), DOH (Bureau of Laboratories), CAP (College of American Pathologists), CLSI ( Clinical Laboratory Standards Institute), FDA , FACT, TJC (The Joint ... Working for this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today at Penn… more
- AbbVie (Waco, TX)
- …collaborate with other departments such as the Device Analysis Lab, Quality Assurance, Regulatory Affairs , Clinical Studies, Customer Care, Operations, and ... and departmental support with a focus on activities linked to compliance to FDA compliance and other applicable Regulatory bodies and AbbVie requirements.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with comprehensive root-cause analysis, risk assessment, and effective CAPAs **Compliance & Regulatory Affairs ** + Ensure QC operations comply with cGMP, ... and phase-appropriate specifications aligned with analytical capability, process understanding, and clinical and regulatory expectations + Represent QC on… more
- Sanofi Group (Waltham, MA)
- …stage. The incumbent is accountable for all statistical aspects of clinical development/medical affairs plans, studies and submissions activities (when ... technical success. + Contribute with project team members (ie: clinical , pharmacovigilance, regulatory , ) to gain Health...packages are delivered and comply with Health Authorities (eg: FDA , PMDA, CDE, KFDA,..) expectations Act as + Represent… more
- Stryker (Portage, MI)
- …on PMS and/or Regulatory Affairs + Experience with global regulatory reporting requirements, including FDA and EU MDR + Demonstrated experience ... in the EU, UK, and Australia in collaboration with Clinical Affairs + Assess and integrate product...+ Review and report medical device complaints to global regulatory agencies within required timeframes + Serve as a… more
- Astrix Technology (Monmouth County, NJ)
- …and quality standards. + Collaborate with cross-functional teams including drug safety, regulatory affairs , clinical development, and biostatistics. + ... assessment reports + Ensure all documents are compliant with regulatory guidelines (ICH, EMA, FDA , etc.), internal...in medical writing with a focus on pharmacovigilance or regulatory affairs . + Strong knowledge of drug… more
- BD (Becton, Dickinson and Company) (Austin, TX)
- …the surgical field. + Work closely with internal teams, including marketing, sales, regulatory affairs , and R&D, to provide scientific insights and support ... Medical Science Liaison (MSL) serves as a field-based scientific and clinical expert, engaging strategically with both internal stakeholders and external healthcare… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …for Xeris' commercial and clinical /late-stage products and projects. + Leads CMC Regulatory Submission support for US FDA and other Health Authorities. + ... Collaborates with other external functions on CMC matters (eg, Quality, Commercial, Regulatory Affairs , etc.). Ensures the CMC function is adequately represented… more