- BeOne Medicines (Emeryville, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead , will be responsible for developing, implementing, and advising on global ... global development, regulatory , and registration strategies. + The Director , Global Regulatory Lead supporting programs within BeOne's Hematology… more
- BeOne Medicines (Emeryville, CA)
- …for product(s) in line with business objectives, and in coordination with the global regulatory leader and key internal stakeholders. This individual will manage ... **General Description:** The Director , Regulatory Affairs will be responsible...the global strategy as determined by the global regulatory leader. + Reviews sections of… more
- BeOne Medicines (Emeryville, CA)
- …is preferred and remote working possible **Location: Remote** **Reports To:** Executive Director , Global Regulatory Strategy, Dx/CDx and Medical Devices. ... **General** **Description:** The Director , Regulatory Affairs, Dx/CDx and Medical...development plans. + Act as the representative of European regulatory team at the global regulatory… more
- BeOne Medicines (Emeryville, CA)
- …leads and communicates CMC regulatory strategies for the assigned projects. + Lead regulatory risk assessment, identify key CMC regulatory issues and ... and process optimizations on relevant topics. **Essential Functions of the job:** + Lead , develop and implement small molecule CMC regulatory strategies as well… more
- BeOne Medicines (Emeryville, CA)
- …from a technology and security perspective across the organization. Working closely with the Director of Global GTS GRC, this position will be responsible for ... **General Description:** BeOne is seeking an Associate Director of GTS Governance, Risk, & Compliance (GRC)...specific functional domains as well as regional SOPs under global Information Security Management System. Lead and… more
- BeOne Medicines (Emeryville, CA)
- …As the Director , Global Commercial, Sonrotoclax, you will lead global initiatives related to professional promotion, omnichannel planning, competitive ... and local cross-functional teams and report to the Executive Director , Global Commercial Lead , Sonrotoclax....events and market dynamics. + Partner with Medical Affairs, Regulatory , Access, and marketing teams to craft responsive and… more
- Abbott (Alameda, CA)
- …**The Opportunity** We are seeking a Director of HCP Marketing to lead global strategy and execution for healthcare professional (HCP) engagement across the ... **What You'll Work On** This role sits within the Global Strategic Marketing (GSM) team and will lead...Work closely with Medical Affairs, Clinical, Market Access, Legal, Regulatory , and Area Marketing teams to ensure scientific rigor,… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** **The Head of Global Clinical Process Management is responsible for designing, implementing, and optimizing processes across multiple ... functionally. You will partner with all functions across Clinical Development and Global Process Owners (GPOs) to shape and execute a continuous improvement plan… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Global Strategic Feasibility Analytics Lead plays a pivotal role in advancing our feasibility data analytics initiatives, serving as ... By leveraging expertise in data analytics and systems, the Global Strategic Feasibility Analytics Lead collaborates with... global clinical operations (GCO). Good understanding of global , regional, and country landscape and regulatory … more
- BeOne Medicines (Emeryville, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often ... response plan, reviews ongoing issue and plan + Reviews regulatory inquiry to lead strategizing the nature...the program / portfolio being led. The Executive Medical Director serves as Product Safety Physician Lead … more
- BeOne Medicines (Emeryville, CA)
- …R&D system category strategy development, like CTMS, Safety system, and regulatory system, etc., vendor selection and supplier relationship management. This position ... trends in R&D system evolving in the industry + Lead and support Business engagement to understand their digitalization...+ English, with preference for bilingual in Chinese **BeOne Global Competencies:** When we exhibit our values of Patients… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director , Digital Clinical Operations - Project Lead , is responsible for coordinating and managing digital initiatives ... within Global Clinical Operations (GCO) to enhance the effectiveness, efficiency,...refinement to ensure digital capabilities meet business needs and regulatory standards. The Associate Director is expected… more
- BeOne Medicines (Emeryville, CA)
- …mission. Leveraging deep therapeutic and functional area expertise, the Clinical Operations Lead in Biotech Unit is accountable for the planning, budget, and ... for annual budget and resource forecasts, as well as lead to define CST goals for the assets +...+ Provide guidance to Execution Unit at regional and global level and ensure timely, quality, and efficient study… more
- BeOne Medicines (Emeryville, CA)
- …Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update ... including individual study design and filing plans. + Experienced in global regulatory requirements for pharmacovigilance. **Education Required:** + PharmD,… more
- Abbott (Alameda, CA)
- …Events Group (MEG) and No Product Return (NPR) will lead global medical device vigilance, post-market surveillance, and regulatory reporting for Abbott's ... compliance with FDA, ISO 13485, EU MDR, and other global regulatory standards. The Director ...regulatory audits and inspections (FDA, ISO, etc.). * Lead and develop the Medical Events Group team, fostering… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** Reporting to the Head/ Director of Clinical Trial Diversity, the Associate Director will operationalize BeOne's clinical trial diversity ... representative patient enrollment. This role collaborates across Clinical Operations, Regulatory , Development, and corporate functions to embed diversity into study… more
- BeOne Medicines (Emeryville, CA)
- …the associated program(s) in the Breast and Women's Cancers Franchise(s). The Franchise Head will lead and manage the Global Clinical Program Lead (GCPL)/ ... Leveraging deep Therapeutic Area/Asset expertise, solid global program management skills, global view,...team of GCO P&SM, participate in shaping P&SM strategy, lead the functional management activities, and apply strategic thinking… more
- BeOne Medicines (Emeryville, CA)
- …their domain, technical and governance expertise as partners of the BeOne Medicines global team. **General Description** The Director , Business Management is a ... BeOne Medicines is a global biopharmaceutical company dedicated to the discovery and...Functions of the job:** **Financial Management & Governance** + Lead the development and execution of the GTS long-range… more
- Grifols Shared Services North America, Inc (Emeryville, CA)
- …Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being ... and services in more than 110 countries and regions. The Associate Director , Value Access Marketing & Reimbursement is responsible for developing and executing… more
- Abbott (Alameda, CA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Director of Product Management, Lingo** **About Abbott** Abbott is a global … more