- AbbVie (North Chicago, IL)
- …The Pharmacovigilance , Patient Safety, Epidemiology, and Quality (PSEQ) Business Process Office is comprised of Business Process Owners (BPOs) who ... are accountable for the definition, health, and performance of Pharmacovigilance 's (PV's) key end-to-end processes. The BPO partners closely with process … more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Associate Director , Global Patient Safety Signal Management and Innovation in ... the "Apply" button, I understand that my employment application process with Takeda will commence and that the information...and Education function, you will report to the Senior Director , Signal Management and represent the pharmacovigilance … 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
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director - Office of Safety Operations PV Systems this ... and technology + Designs and implements compliant and efficient ICSR pharmacovigilance processes, technologies & training + Implements new ICSR pharmacovigilance… more
- ThermoFisher Scientific (Greenville, NC)
- …REMS, RMP and CSR). **General Support:** Ensures tasks delegated to pharmacovigilance are properly executed. Adheres to applicable regulations and ICH guidelines ... the medical content is accurate and complete. Contributes to departmental process improvement initiatives. **Clinical Trial Support:** Monitors all safety variables… 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, ... in supporting innovation/modernization and driving change including analytics education/development, process modernization and increasing productivity with innovative digital solutions.… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …of bipolar depression in adults as monotherapy and as adjunctive therapy. The Associate Director / Director of Medical Writing provides support for the ... documents, and responses to health authority information requests. The Associate Director / Director of Medical Writing...Excel, PowerPoint) + Demonstrated understanding of the drug development process + Ability to travel at least 10% **Key… 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 ... Proposition: Join our dynamic and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your expertise will play a… more
- Merck (Boston, MA)
- …reports to ensure standardization and optimization from both a system and process prospective. + Assist in preparing and responding to Regulatory Agency Inspections ... Collaborate with and maintain effective working relationships with International Pharmacovigilance community and external customers to ensure regulatory compliance… more
- Gilead Sciences, Inc. (Seattle, WA)
- …projects and teams with responsibilities related to clinical trials, pharmacovigilance or other drug development activities. + Experience working with ... Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), Good Pharmacovigilance (GVP) and Electronic Systems Compliance (ESC). + Thorough knowledge… 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 ... and expanding mid-size oncology company in the role of Associate Director , Regulatory Affairs Operations where you...by providing guidance, as well as regulatory system and process support for the US and Europe. At Taiho… 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 ... labeling. + Contribute to the continuous improvement of the end-to-end labeling process . **Qualifications** **Education:** + A bachelor's degree (or equivalent) in a… more
- BeiGene (San Mateo, CA)
- **General Description:** The Associate Director - Clinical Science will support BeiGene Clinical and Medical assets by successful execution of clinical ... academicians and collaboration partners. The candidate will report to the Senior Director , Clinical Development. As a leader in the organization, the incumbent will… more
- ThermoFisher Scientific (Austin, TX)
- …find cures for cancer. What will you do in this role? As an Associate Director , Clinical QA-Regulatory Inspections at Thermo Fisher/ PPD Clinical Research Group, ... in risk assessment activities pertaining to study, site, or process to identify areas of increased risk to studies,...FDA or other Health Authority (HA) related GCP or Pharmacovigilance inspections. Previous experience in clinical QA or clinical… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. Associate Director , HCP Marketing - IgG4-RD **Live** **What you will do** Let's do ... vendors and drive optimal value for brand. Work closely with contracts, pharmacovigilance , and compliance on Master Services Agreements, work orders, and contractual… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director , Safety Scientist in Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical ... other teams with members external to Regeneron. + Actively participate in process improvement initiatives eg the development and maintenance of relevant SOPs, WIs… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance , Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational ... reviews with technical teams to ensure compliance with standards. Leads in process improvement and develops procedures to improve overall IT systems development with… more
- ThermoFisher Scientific (Greenville, NC)
- …(comparable to 1-2 years) in the industry. + Direct experience in safety/ Pharmacovigilance (comparable to 2 years). _In some cases an equivalency, consisting of ... + Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information + Proficiency in basic computer… 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) ... Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners. + Department Coordination:… more
- Boehringer Ingelheim (Denver, CO)
- …level of productivity. + Identifies and develops top PaCE and Senior Associate Director talent. Defines clear objectives, allocates resources, provides ... and develops a staff of Patient and Community Clinical Educators and Senior Associate Directors. The team will educate patients and advocacy partners. + Manages the… more