- Merck & Co. (North Wales, PA)
- …designated as the Business Process Owner for Issue Management, Risk Management, and Quality Plan processes. The Q&C organization now functions under a matrix model, ... Research & Development Division and Enterprise levels. The position supervises two Associate Directors.Primary activities include but are not limited to: Serve as… more
- Insmed Incorporated (San Diego, CA)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , EDC Programming will lead and oversee EDC ... and implementation of EDC systems to support clinical trials, ensuring data quality , compliance, and efficiency throughout the study lifecycle. The AD, EDC… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the ... as well as instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool (eg, disproportionality assessments).This… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …field.Proven leadership abilities, strong knowledge of regulatory frameworks (eg, FDA), GCP guidelines, and quality management systems.Preferred but Not ... Mandatory: Medical practice experience in respiratory medicine.Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ensure ... ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust communication plan including status and timing… more
- Amgen (Washington, DC)
- …continuous improvement. + Provide hands-on support to the Senior Manager/ Associate Director in ensuring procedural compliance with GCP standards and other ... transform the lives of patients while transforming your career. ** GCP Quality Compliance Manager** **What you will...experience OR + Bachelor's degree and 4 years of Quality /Compliance/Process Management experience OR + Associate 's degree… more
- Amgen (Washington, DC)
- …to the Senior Manager of R&D Supplier Governance, you will help ensure the quality and integrity of processes and data generated by service suppliers for these ... sponsored clinical trials + Monitoring and evaluating Supplier compliance and data quality + Tracking corrective actions in relation to monitoring issues and audit… more
- GRAIL (Menlo Park, CA)
- …Grail's partnerships with pharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director , Clinical Compliance will play a key leadership ... 14155, IVDD/IVDR), US [21 CFR Part 812 and Part 11]. + Experience managing GCP quality processes such as managing Quality Events and CAPAs; and participating… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical and Safety Quality Compliance is responsible for ... and Statistics, with at least 3 years of experience in GCP Quality /Compliance. + Advanced knowledge of pharmaceutical development, medical affairs and … more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **About the role:** Associate Director , Clinical Program Quality Investigations is responsible for ... and Statistics, with at least 3 years of experience in GCP Quality /Compliance. + Advanced knowledge of pharmaceutical development, medical affairs and … more
- IQVIA (Durham, NC)
- …teams to improve patients' lives by bringing new drugs to the market faster. The Associate Clinical Lead Director is a member of the core project team ... **Job Overview:** Associate Clinical Lead Directors are an integral part of clinical trial delivery, leading and working alongside clinical… more
- Ascendis Pharma (Palo Alto, CA)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Associate Director , PV Vendor Management Team reports to the Director , Head, ... of PV Vendor Management by contributing to the Vendor Quality Agreements + Accountable for maintaining oversight over Source...of CAPAs as necessary + Work Closely with Ascendis GCP /PV Compliance team and Commercial organization as required to… more
- University of Pennsylvania (Philadelphia, PA)
- …wealth of health and wellness programs and resources, and much more. Posted Job Title Associate Director C, Research Job Profile Title Associate Director ... cognitive impairment, cognitive aging, and lifelong brain health. We are seeking an Associate Director of Clinical Research Operations to oversee the operational… more
- ThermoFisher Scientific (Las Vegas, NV)
- …find cures for cancer. Due to continued growth, we are looking to appoint an Associate Medical Director at the Las Vegas Clinical Research Unit. This role is ... an office-based position for a motivated Physician. The Associate Medical Director serves as the physician...being conducted under all applicable laws, regulations and per ICH- GCP guidelines in the organization's Clinical Research Unit (CRU).… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Associate Director , Good Pharmacovigilance Practice (GVP) Audits, serves as ... a key role within Gilead's R&D Quality Organization. This role is responsible for executing internal...Program. Reporting to the Head of GVP Audits, the Associate Director contributes to the strategic development… more
- Regeneron Pharmaceuticals (Armonk, NY)
- Regeneron Pharmaceuticals has an exciting new opportunity as an Associate Director , Diagnostics Project Management & Delivery **In this role, a typical day might ... include:** The role of Associate Director , Diagnostics Project Management & Delivery,...tools to support and the Diagnostics function to ensure quality , efficient and timely delivery + Effectively partner with… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management and Statistics, with at least 3 years of experience in GCP Quality /Compliance. + Advanced knowledge of pharmaceutical development, medical affairs ... of my knowledge. **Job Description** **OBJECTIVES:** + Ensures Global and R&D Quality processes are embedded and effectively implemented across CPMQ + Partner with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** **Job Responsibilities:** + Lead in the development and implementation of quality strategy and associated capabilities to support the CDS objectives + ... Manage quality review of clinical trial documents, workflows, and outputs...clinical trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations + Analyze trends to… more
- Bristol Myers Squibb (Devens, MA)
- …source systems.** + **Integrate structured and unstructured data from manufacturing, quality , and digital platforms into unified, accessible formats.** + **Support ... Apache Airflow, DBT).** + **Experience with cloud platforms (eg, AWS, Azure, GCP ) and data warehousing solutions (eg, Snowflake, Redshift).** + **Familiarity with… more
- Takeda Pharmaceuticals (Boston, MA)
- …to ensure the effective execution of the clinical studies on time, with high quality and within agreed budget. **ACCOUNTABILITIES:** + Accountable to the GPT for the ... research, including but not limited to US CFR, EU CTD, and ICH GCP . Awareness of local country requirements is also required. **Skills:** + Demonstrated excellence… more
