- 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)
- …Description:** The incumbent will: + Lead the activities of the Global Regulatory Affairs SOP Committee regarding life-cycle management of Global ... the Document Change Process + Guide external personnel to Global Regulatory Affairs to comply with SOP...biotechnology industry, with 5+ years of experience as a Regulatory Affairs compliance lead . **Other Qualifications:** +… 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)
- …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)
- …strategy across multiple channels to enhance BeiGene's engagement with the global medical oncology/hematology community. This is a remote-based leadership role. ... **Essential Functions of the job:** Under the leadership of the Executive Director , GMA LD&C, collaborate cross-functionally to develop and implement a comprehensive… more
- BeiGene (Emeryville, CA)
- … the analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports ... Qualifications:** + Pharmaceutical product development experience + Experienced in global regulatory requirements for pharmacovigilance **Travel:** Less than… 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)
- …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
- 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
- BeiGene (Emeryville, CA)
- **Position Summary** The Director of Statistical Programming is responsible for the organization and strategic leadership of a statistical programming unit / ... of programmers to ensure projects are appropriately staffed. + Lead or contribute to the development or adoption of...Word, Excel, PowerPoint) + Knowledge of CDISC and other industry/ regulatory standards + Computer programming using SAS or R… more