- BeiGene (Emeryville, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead , will be responsible for developing, implementing, and advising on global ... on Health Authority interactions. + Uses extensive knowledge of global regulatory requirements and the ability to...a global strategy and can develop and lead execution of holistic regulatory strategy while… more
- BeiGene (Emeryville, CA)
- The Executive Director , Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising on global regulatory ... Functions of the job:** + Uses extensive knowledge of global regulatory environment and the ability to...+ Preferred candidates will have experience working as a lead in Regulatory Affairs across two or… more
- BeiGene (Emeryville, CA)
- …of department policies. **Key Responsibilities:** Regulatory Strategy Development: + Lead the global regulatory strategy for companion diagnostics, ... The Executive Director of Regulatory Affairs, Companion Diagnostics...will be responsible for developing, advising on and executing global regulatory strategies for companion diagnostic products… more
- BeiGene (Emeryville, CA)
- **General** **Description** _:_ The Executive Director , Hematology North America Lead will be responsible for managing a team of NA leaders within the Hematology ... coordination with key internal stakeholders. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of at least 2 strategist) who… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site at our ... Abbott is a global healthcare leader that helps people live more...Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - US New Product Introduction and ... regulatory metrics/information. **WHAT YOU'LL DO** + Develop global regulatory strategies for product development and...unit assigned. + Create project plans and timelines. + Lead functional groups in the development of relevant data… more
- BeiGene (Emeryville, CA)
- …manage pricing decisions, ensuring adherence to corporate policies, ethical guidelines, and regulatory requirements. + Lead global pricing reviews, develop ... Global Head Strategic & Operational Pricing will lead the development and execution of global ...with senior leadership. + Monitor compliance with internal controls, global pricing policies, and external regulatory requirements.… more
- BeiGene (Emeryville, CA)
- …to the VP of Global Business Operations, the Senior Director , Global Congresses and Meetings will lead a team of congress and events professionals ... team. The role provides an opportunity to shape and lead the BeiGene Global Congress and Meetings...a compliant manner with BeiGene policies, procedures, and local regulatory /legal requirements, company policies and code of conduct. +… more
- BeiGene (Emeryville, CA)
- …and takes a lead role in vendor governance + Champions a global mindset and approach across Clinical Operations to foster increased collaboration and consistency ... and execution of clinical operations' deliverables at the regional level + Lead therapeutic area/s (TA) within Clinical Operations with responsibility for line… more
- BeiGene (Emeryville, CA)
- …Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update ... experience, including individual study design and filing plans. + Experienced in global regulatory requirements for pharmacovigilance. **Travel:** Less than 10%… more
- BeiGene (Emeryville, CA)
- **General Description:** The Risk Based Quality Management Lead will create risk assessments for any entity in clinical development, follow up on quality signals, ... agreed results against a plan and timeline + Understanding of ICH and regulatory environment + Problem-solving skills + Self-management skills + Ability to work in… more
- BeiGene (Emeryville, CA)
- …improvement initiatives with cross functionally with stakeholders contributing to global /regional initiatives or programs. + Lead monthly Supply ... **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply...Regulatory , etc.) stakeholders. + Demonstrates advanced knowledge of global clinical trials and the drug development process. +… more
- BeiGene (Emeryville, CA)
- …Americas, Clinical Operations, the Director - Clinical Trial Diversity, will lead BeiGene's goals to increase global clinical trial diversity across ... This role will work actively and directly with the Clinical Operations, Regulatory , Clinical Development, and Human Resources to support their efforts to advance… more
- BeiGene (Emeryville, CA)
- …CMC, Regulatory , etc.) stakeholders. + Demonstrates advanced knowledge of global clinical trials and the drug development process. + Experience in vendor ... The Director of Comparator Purchasing, Clinical Supply Chain is...IRT system functionality and Excel modeling. + Understands comprehensive global pharmaceutical regulatory requirements (eg cGMP, ICH/GDP,… more
- BeiGene (Emeryville, CA)
- …and actively monitor vendor performance trends **Supervisory Responsibilities:** + Build & Lead global Digital Study Clinical Operations team of digital business ... **General Description:** The Director of Digital Clinical Operations Solutions Head is...the GCO digital strategy with the goal to increase Global Clinical Operations' productivity, reduce rising costs of clinical… more
- BeiGene (Emeryville, CA)
- …partners and internal stakeholders **Desired Qualifications:** + Strong understanding of global manufacturing processes, supply chain management, and regulatory ... **General Description:** The Executive Director for Manufacturing Operations Business Development will be responsible for identifying, evaluating, and developing new… more
- BeiGene (Emeryville, CA)
- …product communications, including launch preparedness. + Well-versed in FDA, EMA and global regulatory guardrails. + Proficiency in Veeva is advantageous. ... **General Description:** Director , Solid Tumor Franchise Communications is responsible for...leadership and Chief Medical Officer, Solid Tumors. + Directly lead and manage Tevimbra communications programs, including creating and… 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 ... diversity, working mothers, female executives, and scientists. **The Opportunity** The Director , Business HR provides consulting and functional expertise to a… more
- BeiGene (Emeryville, CA)
- …of escalation for resolution of issues of the associated program(s) in the Franchise(s) + Lead and manage the Global Clinical Program Lead (GCPL)/ Global ... **General Description:** + Leveraging deep Therapeutic Area/Asset expertise, solid global program management skills, global view, and borderless leadership, the… more
- AIG (San Francisco, CA)
- Claims Complex Director - Healthcare Professional Liability (HPL) Join us as a Claims Complex Director to take on key responsibilities within a world-class ... excellence and showcasing our service differentiation to create an unparalleled global claims handling experience. Through a robust stakeholder feedback loop and… more