- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study ... decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup. This position requires strong organization and interpersonal… more
- Ascendis Pharma (Palo Alto, CA)
- …We offer a dynamic workplace for employees to grow and develop their skills. Associate Director , Medical Safety Science reports to Head of Global Medical Safety ... Assists Head of Global Medical Safety Science for drug safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and… more
- United Therapeutics (Columbus, OH)
- …cardiovascular and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Associate Global PV Case Management Director plays a key role in ... safety data collection, management and reporting for postmarketing ICSRs for efficiency, quality , and compliance impacts. This role is critical in ensuring that… more
- BD (Becton, Dickinson and Company) (El Paso, TX)
- … pharmacovigilance , post market surveillance, GMP Auditing and Supplier Management. The Associate Director , Quality Management and QA Site Leader ensures ... audits/inspections and provides leadership during regulatory authority visits. The Assoc. Director leads quality programs, continuous improvement efforts, and… more
- Novo Nordisk (Plainsboro, NJ)
- …grows. Relationships Reports to the Sr. Director , Patient Support Solution Quality /Safety Associate Director . Interacts with colleagues within Patient ... to maximize your potential with us? The Position The Associate Director will be the lead who...responsible for ensuring that all aspects of our patient quality and safety operations meets standards. This position requires… more
- Novo Nordisk (Plainsboro, NJ)
- …to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …systems, configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ... documents and evidence + Support with implementing and ensuring global DBMA quality standards for Change requests **IT Vendor Oversight and Management** + Managing… more
- AbbVie (North Chicago, IL)
- …to our talent pipeline and considered for future opportunities. The Associate Director (AD) of Epidemiology in Pharmacovigilance & Patient Safety leads the ... and evaluation, signal detection, and signal validation. Familiar with quality assurance, legal and regulatory functions, database functionalities, and management… more
- Takeda Pharmaceuticals (Boston, MA)
- …for CPMQ activities eg audit, inspection, QE, CAPA. + Organise Clinical and Pharmacovigilance Quality council meetings and proactively manage the agenda and ... of my knowledge. **Job Description** **OBJECTIVES:** + Ensures Global and R&D Quality processes are embedded and effectively implemented across CPMQ + Partner with… more
- ThermoFisher Scientific (Greenville, NC)
- …communities depend on - now and in the future. **Discover Impactful Work:** The ( Associate ) Medical Director will provide medical support and medical advice for ... spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and… more
- AbbVie (Chicago, IL)
- …, YouTube and LinkedIn. Job Description The Associate Director (AD) of Epidemiology in Pharmacovigilance & Patient Safety ... and evaluation, signal detection, and signal validation. Familiar with quality assurance, legal and regulatory functions, database functionalities, and management… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation. + Establishes Processes and Best Practices: Reinforces labeling… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance , Regulatory/Risk Management, Quality Assurance, Medical Affairs, ... Translational Research, Research, Informatics Services, Project Management and Operational Management. The Tech Lead must have the ability to develop a strong, positive strategic business partnership with the global business and Global IT functions at Daiichi… more
- AbbVie (South San Francisco, CA)
- …LinkedIn. Job Description In collaboration with a therapeutic area, the Scientific Director , Clinical Science will lead the design, conduct, analysis, and reporting ... in cross-functional teams to generate, deliver, interpret and communicate high- quality clinical data supporting overall product scientific and business strategy.… more
- AbbVie (North Chicago, IL)
- …Participates in cross-functional teams to generate, deliver, and interpret high- quality clinical data supporting overall product scientific and business strategy. ... and IRBs regarding safety issues and queries. + May oversee the work of Associate Medical and/or Scientific Directors and of Clinical Scientists working on the same… more
- AbbVie (North Chicago, IL)
- …Participates in cross-functional teams to generate, deliver and interpret high- quality clinical data supporting overall product scientific and business strategy. ... and responses and other program documents. + May oversee the work of Associate Medical and/or Scientific Directors and of Clinical Scientists working on the same… more
- AbbVie (North Chicago, IL)
- …Participates in cross-functional teams to generate, deliver, and interpret high- quality clinical data supporting overall product scientific and business strategy. ... and responses, and other program documents. + May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same… more
- AbbVie (Irvine, CA)
- …submissions and responses and other program documents. *May oversee the work of Associate Scientific Directors and/or of Clinical Scientists working on the same or ... for key regulatory discussions. *Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …, integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. **Functional Expertise:** ... assigned programs, collaborating with program teams, clinical safety and pharmacovigilance , CROs, and partners to ensure high quality...DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …with US and Global Medical Affairs Teams and other Grifols stakeholders (eg, Quality , Pharmacovigilance , RandD etc.) to develop and maintain a library of ... and other stakeholders. The Senior Manager ensures accurate, complete, and high- quality scientific communications through the creation and maintenance of medical… more
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