- Exelixis, Inc. (Alameda, CA)
- … requirements. This individual will assist in growing and establishing the Trade Compliance program and facilitate a training program to establish ... of subject matter experts throughout the company to ensure compliance within the program . This person will...in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing… more
- Freelancer (San Francisco, CA)
- We are seeking a highly skilled Compliance Program Lead to oversee and enhance our regulatory compliance initiatives. This role is responsible for ... drafting and process improvement initiatives, contributing to the enhancement of a compliance program . Familiarity with privacy regulations such as GDPR, CCPA,… more
- Abbott Laboratories (Alameda, CA)
- …and capacity alignment-in collaboration with IT Business Relationship Managers. Lead and refine governance processes that provide senior business leaders ... both internal and external stakeholders. Core Responsibilities: Strategic Planning & Leadership Lead the development and annual refresh of the ADC IT strategic… more
- Exelixis, Inc. (Alameda, CA)
- …accountable for driving a risk based, comprehensive implementation of the DI program meeting cGxP regulations, and responsible for Computer System Validation (CSV) ... cross functionally to establish, implement and report metrics to measure compliance and continuous improvement, assess, resolve and/or escalate CSV/DI issues and… more
- Exelixis, Inc. (Alameda, CA)
- …aligning technical approaches with business priorities**Operational Excellence, Quality & Compliance : Drive operational and technical excellence across one or more ... Make decisions regarding access, permissions, and security controls across systems* Lead incident response and root cause analysis for high-impact issues* Contribute… more
- ULTA Beauty (Alameda, CA)
- …training, and development), and process (standard operating procedures and compliance standards). This position requires a passion for process excellence, ... a drive for results, and the ability to lead , influence and develop their team. PRINCIPAL DUTIES &...and providing clear direction. Execute the Guest Engagement Leader program flawlessly through business ownership, associate coaching, and leading… more
- Abbott Laboratories (Alameda, CA)
- …a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program , and FreeU education benefit - an affordable and convenient path to ... opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives. As a global leader in diabetes care, Abbott is… more
- Exelixis, Inc. (Alameda, CA)
- …in a timely fashion, and aligning metrics that provide input into a compliance scorecard for Clinical programs. This leader provides insight and partners with both ... groups including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding compliance issues and provides compliance guidance* Maintains… more
- Exelixis, Inc. (Alameda, CA)
- …as well as with cross-functional project teams.**ESSENTIAL DUTIES/RESPONSIBILITIES: Lead development of high quality, phase appropriate CMC-related submissions ... to publishing, including submissions across multiple countries and clinical studies.* Lead development of responses to health authority questions and documentation… more
- Abbott Laboratories (Alameda, CA)
- …with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to ... work for diversity, working mothers, female executives, and scientists Role Description Lead global Customer Service operations across internal and BPO models to… more
- Exelixis, Inc. (Alameda, CA)
- …operational responsibilities and consistent with the requirements of the Company's Healthcare Compliance Program .* Ongoing tracking and evaluation of legal and ... advisory board agreements, and certain vendor services agreements.* Advise on compliance with OUS clinical trial recruitment efforts and proactive MSL activities.*… more
- Exelixis, Inc. (Alameda, CA)
- …Knowledge of anti-drug antibodies (ADA) assay is preferred.**ESSENTIAL DUTIES/RESPONSIBILITIES: Lead outsourced bioanalysis and work with CRO to establish robust ... plans, protocols, data and reports to ensure scientific integrity and compliance with regulatory requirements.* Serve as project manager for timelines, contracts,… more
- Saildrone, Inc. (Alameda, CA)
- …maximized for performance, reliability, schedule attainment, and cost-efficiency. You will lead global, 24/7 operational teams to maintain, allocate, and execute ... directly with Customer Success and Account Managers. Develop global operational strategy: Lead a 24/7 global team, including Fleet Captains who manage specific USV… more
- Exelixis, Inc. (Alameda, CA)
- …partners, including field sales, sales training, market planning, and regulatory/ compliance * Collaborate with the Patient/APP Marketing Team to develop promotional ... marketing and sales teams and with partners throughout the organization* Ensure compliance with all laws, regulations, and policies that govern Exelixis conduct* The… more
- Exelixis, Inc. (Alameda, CA)
- …to day-to-day management of employees, reducing legal risks and ensuring regulatory compliance . Partner with the legal department as needed/required* Act as a coach ... job benchmarking and job grading* Mentor HR Partners* Take the lead on process mapping for HRBP-related tasks/processes**SUPERVISORY RESPONSIBILITIES: There are no… more
- Exelixis, Inc. (Alameda, CA)
- …documentation (eg, protocols, informed consents, clinical study reports) for compliance with regulatory guidance and alignment with study objectives and ... including developing and authoring internal work instructions and company SOPs.* Lead multiple assets and/or studies as assigned.* Liaise internally with members… more
- Exelixis, Inc. (Alameda, CA)
- …statistical programming standards, tools, and infrastructure. This role ensures compliance with regulatory requirements, industry standards (eg, CDISC), and internal ... matter expert for programming standards during audits and regulatory inspections.* Lead and mentor a team of statistical programmers and standards specialists.*… more
- Exelixis, Inc. (Alameda, CA)
- …Biologics Licensing Application (BLA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product ... and correspondence.* Assist with developing and implementing strategies to ensure compliance with HA requirements.* Respond to requests for information from… more
- Exelixis, Inc. (Alameda, CA)
- …provide cross-functional leadership in these areas.This role requires a well-established CDM Lead , with a recognized track record of leading the delivery of clinical ... in department process development and optimization of related clinical research activities. Lead or support the initiatives to drive change within CDM/BSD as well… more
- Exelixis, Inc. (Alameda, CA)
- …Investor Relations/Public Affairs, Human Resources, Real Estate, Facilities, IT, Compliance and others), supporting the wide range of transactional and ... the base salary, as part of our Total Rewards program , Exelixis offers comprehensive employee benefits package, including a...in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing… more
