- ThermoFisher Scientific (Austin, TX)
- …helping find cures for cancer. What will you do in this role? As an Associate Director , Clinical QA- Regulatory Inspections at Thermo Fisher/ PPD Clinical ... Health Authority (HA) related GCP or Pharmacovigilance inspections. Previous experience in clinical QA or clinical compliance related functions desired.… more
- Charles River Laboratories (CA)
- …career that you can feel passionate about. **Job Summary** We are seeking anexperienced ** Director of Regulatory Services & Compliance ** to join our ... San Diego, CA, or San Francisco, CA.** As the ** Director of Regulatory Services & Compliance...suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this… more
- BAYADA Home Health Care (Pennsauken, NJ)
- …outcomes. The Division Director of Clinical Practice will ensure compliance with regulatory , accreditation, and clinical billing requirements. This ... leader, **Registered Nurse or Physical Therapist** , to fill the role of Division Director of Home Health Clinical Practice. The Division Director of Home… more
- Healthfirst (NY)
- …and oral (ie, conference calls, face-to-face meetings and presentations) Compliance & Regulatory Responsibilities: See Above License/Certification: N/A ... form of information requested from the team that could possibly have regulatory implications + Monitors changes in regulations and ensures the organizations policies… more
- HealthEdge Software Inc (Columbus, OH)
- …Marketing stakeholders to establish clinical product positioning as it pertains to regulatory compliance (ie what is/should be a care management system & ... ability to discern the role of the vendor in regulatory compliance . **About Wellframe:** _With Wellframe,_ we...and our software. + Partner with enterprise legal & compliance team to identify and document clinical … more
- Kelly Services (Alameda, CA)
- ** Regulatory Affairs Policy, Intel, & Compliance Director ** + Direct Hire + Location: Alameda, CA or King of Prussia, PA + The base pay range: $183,000 - ... System. Establishes processes and measures to monitor conformance with Regulatory Affairs procedures and compliance with ...the Kelly Talent Community. Why Kelly (R) Science & Clinical ? Kelly Science & Clinical is your… more
- The Mount Sinai Health System (New York, NY)
- … reviews. + Communicate concerns regarding violations of compliance or regulatory standards to the Principal Investigator, and Director of Interventional ... **JOB DESCRIPTION** The Research Regulatory and Compliance Manager is responsible...received or investigation outcomes. + Work closely with the Director of Interventional Cardiovascular Research and the Clinical… more
- Houston Methodist (Houston, TX)
- …and study specific protocols/plans and processes. The Regulatory Compliance Specialist position maintains documentation for clinical research studies, ... procedures under the direct supervision of the Manager or Director (serves as a resource for regulatory ...Maintains the required regulatory files for all clinical trials to ensure regulatory compliance… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** Review promotional claims and materials for BI Rx drug promotion for compliance with Food Drug Cosmetic Act (FDCA) and for consistency with product ... labeling. Participate in Human Pharmaceutical Review Committee, providing regulatory opinion on promotional communications. Review scientific exchange communications… more
- United Therapeutics (Durham, NC)
- …and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Counsel, Regulatory & Compliance role is responsible for a broad range of ... approval for five medicines, we are always conducting new clinical trials, and we are working to create an...legal, regulatory and compliance issues affecting the pharmaceutical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in process improvements, procedural documents, and quality and inspection readiness for Clinical Operations. The Associate Director , will be a key member ... non- compliance . + Maintain awareness of changes within the industry and regulatory environment to ensure Clinical Operations alignment + Determine, develop,… more
- HCA Healthcare (Nashville, TN)
- …accreditation, certification and licensure compliance of all facilities. HCA Healthcare clinical strategies and regulatory compliance are foundational to ... Do you want to join an organization that invests in you as a Senior Director Regulatory and Accreditation? At HCA Healthcare, you come first. HCA Healthcare has… more
- HCA Healthcare (Nashville, TN)
- …accreditation, certification and licensure compliance of all facilities. HCA Healthcare clinical strategies and regulatory compliance are foundational to ... Do you want to join an organization that invests in you as a(an) Director Regulatory and Accreditation? At HCA Healthcare, you come first. HCA Healthcare… more
- UNC Health Care (Chapel Hill, NC)
- …care. Accountable for departmental Personnel Management, Education, Accreditation and Regulatory Compliance , Fiscal Management, Communication, Customer Service, ... to guide decision making, validate, coach, counsel, and evaluate staff performance. + Regulatory Compliance , Accreditation, & Quality - Ensures compliance … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called ... to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical ...to support international CTA submissions. + oversees preparation of regulatory submissions to ensure compliance with all… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …to ensure e-CTD compliance . + As required, serves as a global regulatory lead on a specific or assigned clinical program. **Qualifications** + Bachelor's ... on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global regulatory… more
- Bristol Myers Squibb (Summit, NJ)
- …and vendor audit and inspection strategies to ensure compliance with regulatory requirements and company standards. The Executive Director will work closely ... clinical quality councils. In addition, the Executive Director will provide credible compliance advice and...ensure compliance with GCP, ICH guidelines, and regulatory requirements. + Translate risk factors into clinical… more
- Stryker (San Jose, CA)
- …publicly disseminated information on product submission approval status + Review regulatory compliance requirements for changes affecting product submission and ... link to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) The ** Director , Regulatory Affairs** is a key strategist,… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , North America Regulatory Lead - 2406196976W **Description** Johnson & Johnson Innovative Medicine is recruiting for Associate Director , ... At Johnson & Johnson, we all belong. The Associate Director , Regulatory Affairs will be responsible for...+ Performing critical review of submission documents to ensure compliance with regulatory requirements. + Participates in… more
- Ascendis Pharma (Palo Alto, CA)
- …and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation ... dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and implementing… more