- Daiichi Sankyo, Inc. (Bernards, NJ)
- …3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more
- Daiichi Sankyo, Inc. (Bernards, 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. Develop a strong, positive strategic business partnership with the global R&D business and Global IT functions of Daiichi Sankyo. As a trusted partner,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other safety information for all Novo Nordisk products. Relationships Reports to Associate Director , Patient Safety Training. Internal relationships include all ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....Patient Safety (PS) employees' onboarding and on-the-job training for pharmacovigilance as well as Safety training conducted for internal… more
- AbbVie (North Chicago, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Pharmacovigilance , Patient Safety, Epidemiology, and Quality (PSEQ) Business Process ... as well as a high level of business acumen specifically in Pharmacovigilance , Individual Case Safety Report Processing, Quality System Management and/or… more
- BeiGene (Emeryville, CA)
- **General Description:** _The Associate Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages ... in departmental activities **Supervisory Responsibilities:** This position has no direct reports. The Associate Director , Safety Scientist is part of a team that… more
- Ascendis Pharma (Palo Alto, CA)
- The Associate Director , Global PV Operations reports directly to the Head of Global PV Operations. Under the direction of the Head of Global PV Operations, is ... Safety Report, DSUR, IND Annual Report, etc.) + Provides pharmacovigilance expertise to Ascendis or CRO/Vendor staff when needed...of Global PV Operations by contributing to the Vendor Quality Agreements + Liaise with functional units to identify… more
- Gilead Sciences, Inc. (Seattle, WA)
- …and any regulatory or other requirements. **This position will be filled at the Associate Director or Senior Manager level, based on experience of the identified ... possible, together. **Job Description** Job Description You will act as the R&D Quality Business Partner to assigned groups, such as Gilead R&D functions or vendors… more
- BeiGene (San Mateo, CA)
- **General Description:** The Associate Director R&D Quality Excellence, Analytics, and Innovation is responsible for supporting and maintaining a proactive, ... + Clinical Operations + Data Management + Risk Based Quality Management + Pharmacovigilance + Clinical Business Operations + Biometrics + Medical Monitors… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **Job Title** : Associate Director , Clinical Quality Compliance **Location** : Cambridge, MA **About ... the role:** As the Associate Director , Clinical Quality Compliance,...Experience must include successful implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections and remediation activities… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **Job Title** : Associate Director , CPMQ Strategy and Innovation **Location** : Cambridge, MA **About ... as strategic thought partner to the Head of Clinical, Pharmacovigilance , and Medical Quality (CPMQ) and the CPMQ Leadership Team, driving new opportunities… more
- System One (Basking Ridge, NJ)
- Associate Director , Clinical Safety MD Pharma In New Jersey - Remote (no west coast, only EST or CST) 12 month contract | Up to $100/hr dependent on experience. ... + international MD is okay + 1-3 years of Pharmacovigilance (PV)/clinical safety experience in pharmaceutical drugs either from...get work done more efficiently and economically, without compromising quality . System One not only serves as a valued… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Epidemiology is a member of the Global Epidemiology ... in Pharmacovigilance & Patient Safety, Epidemiology, R&D Quality ...development of capabilities/methodology to bridge knowledge gaps. The Epidemiology Associate Director provides expertise in regulatory pharmacoedemiology… 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
- Taiho Oncology (Princeton, NJ)
- Associate Director , Outsourcing & Vendor Management Pleasanton, CA, USA * Princeton, NJ, USA Req #385 Friday, August 16, 2024 Looking for a chance to make a ... dynamic and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your...with key internal stakeholders including R&D Functions, Finance, Legal, Quality , to negotiate MSA, SOW/WO, and Change Order. +… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Associate Director , Medicines Quality Organization (MQO) - Safety role is ... quality improvement of the functions he/she supports. The Associate Director is responsible for managing the... systems and/or experience in a quality control/ quality assurance role ▪ Knowledge of pharmacovigilance … more
- J&J Family of Companies (Columbus, OH)
- Associate Director , Signal Detection Scientist - 2406212640W **Description** Johnson and Johnson is currently seeking an ** Associate Director , Signal ... programmatic surveillance of adverse event reports for potential safety and product quality issues. * Assist in the evaluation of novel, computer-assisted tools, and… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make a ... Join our dynamic and expanding mid-size oncology company in the role of Associate Director , Regulatory Affairs Operations where you will utilize your knowledge… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , RA Labeling Product Leader (1 of 2) - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate ... on the primary or derived labeling, or the supporting documentation. Ensure high- quality and compliant labeling documents. This role may collaborate with external… 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… 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. ... responses and discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality… more
