Senior Manager, Regulatory Diagnostics
1 day ago
General Description: The Senior Manager, Regulatory Diagnostics will lead the development, planning, and execution of IVD related regulatory deliverables in line with program strategies and cross-functional initiatives. This individual will represent Regulatory Diagnostics on cross-functional teams, provide guidance on regulatory strategy and tactics, and coordinate with key stakeholders, as required. The Senior Manager will also lead Regulatory Diagnostics initiatives, authoring of IVD related regulatory documentation, and will partner with regulatory team members for management of regulatory documentation and submissions. Externally, this individual will interface with device partners and applicable regulatory agencies/HAs. Essential Functions: Develop and implement strategies for the earliest possible approvals/clearance of regulatory submissions associated with IVD device use for assigned studies. Gain required clearances for IVD device use for assigned studies. Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory documentation as required for investigation and registration of products in the US and abroad. Ensure the accuracy of IVD device language for protocols, ICFs, and related study documentation. Ensure regulatory submissions are maintained in compliance with regulatory requirements. Address device inquiries from FDA/HAs, IRBs/sites, and partners. Support and manage preparation of IVD device aspects for meeting requests and briefing documents. Lead interactions/meetings with FDA, device partners, and others for included device(s) as applicable. Support study teams by providing expertise on regulatory matters related to IVD device use and associated risks; advise teams on device strategy. Coordinate with device partners for device use and filings/registrations as applicable. Maintain IVD medical device regulatory knowledge and advise management and related stakeholders of significant developments. Prepare and maintain regulatory archives. Work with external IVD device partners, regulatory consultants, and CRO’s as required. Knowledge & Skills: • Working knowledge of FDA and ICH regulatory guidance and regulations. Understanding of FDA structure and functions; knowledge of/experience with regulatory requirements for other regions also desirable. Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism. Experience with MS Office Suite and publishing documents in Adobe Acrobat Professional. Experience with CTD/eCTD Excellent verbal and written skills; able to analyze, define, and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders. Skilled in conflict resolution/negotiation, fosters open communication; listens, and facilitates discussion. Strong negotiating skills and ability to think creatively and develop creative solutions. Proven ability to build trust and respect within the organization. • Ability to prioritize and handle multiple projects simultaneously. Experienced with interactions with external business partners and regulatory agencies. CDx development and submission experience strongly preferred. Experience: Bachelor's Degree required with a minimum of 7 years of experience in the biotechnical or pharmaceutical industry and minimum of 4 years of experience in a regulatory capacity, or 7 years of direct experience with in-vitro diagnostic development / companion diagnostics. Preferred candidates will have regulatory affairs experience with companion diagnostics and biomarker development. Travel: Minimal travel (
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Senior Manager, Medical Writing
1 week ago
Emeryville, United States BeiGene Full timeJob Summary:The Senior Manager, Medical Writing is responsible for writing, editing, and formatting clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project timelines and to oversee these activities in more junior medical writers. Clinical regulatory documents...
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Senior Manager, Medical Writing
7 days ago
Emeryville, United States BeiGene Full timeJob Summary:The Senior Manager, Medical Writing is responsible for writing, editing, and formatting clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project timelines and to oversee these activities in more junior medical writers. Clinical regulatory documents...
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Emeryville, United States BeiGene Full timeGeneral Description : The Executive Director, Hematology North America Lead will be responsible for managing a team of NA leaders within the Hematology franchise and supporting the development of North America Strategy across the hematology programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with...
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Senior Manager, Quality Assurance
3 weeks ago
Emeryville, United States Kyverna Therapeutics Full timeKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the...
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Senior Project Manager
4 hours ago
Emeryville, California, United States IPS-Integrated Project Services, LLC Full timeSenior Project Engineer PositionAt IPS, we are seeking a talented Senior Project Engineer to join our dedicated team. In this role, you will provide technical, administrative, and subcontractor management support to Project Managers and Project Directors.Key Responsibilities:Develops working knowledge of prime contract requirements and applies knowledge to...
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Senior Corporate Accounting Manager
4 weeks ago
Emeryville, United States LHH Recruitment Solutions Full timeJob DescriptionJob DescriptionLHH Recruitment Solutions is working with one of our clients looking to fill a Senior Accounting Manager job opportunity for the corporate office located in Emeryville, CA. This position is hybrid and will need to be in-office 1 or 2 days a week. The ideal candidate will have 8 plus years of experience as a senior level...
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Senior Manager, Pricing
4 weeks ago
Emeryville, United States BeiGene Full timeGeneral Description: The Senior Manager, Pricing & Contracting will be responsible for monitoring and analyzing the effectiveness of pricing strategies and contracting agreements, providing data-driven recommendations for necessary adjustments. The ideal candidate will have a strong understanding of the US Market Access environment, including pricing,...
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Senior Manager, Monitoring Oversight
4 weeks ago
Emeryville, United States 4D Molecular Therapeutics Full timeAttention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT...
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Senior Human Capital Management Systems Leader
23 hours ago
Emeryville, California, United States Vituity Full timeTransform Healthcare with VituityWe are seeking a Senior Human Capital Management Systems Leader to join our team at Vituity. This is an exciting opportunity for someone who wants to make a difference in the lives of patients and healthcare professionals.About the RoleThe Senior Human Capital Management Systems Leader will lead our Human Resources...
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Emeryville, California, United States Tanium Full timeTanium's Senior Software Engineer OpportunityThe Basics of a Hybrid Role:As a Senior Software Engineer at Tanium, you will be responsible for building and maintaining best-of-breed products as part of an agile development team. Our customer engagement model focuses on feedback and iteration to ensure our products meet customer needs.Key...
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Senior Healthcare Project Coordinator
3 hours ago
Emeryville, California, United States Ratcliff Architects Inc. Full timeProject Manager Role OverviewRatcliff Architects Inc. is a renowned regional leader in the planning and design of complex healthcare facilities, including acute and ambulatory care facilities as well as medical campus master plans.About the JobWe are seeking an experienced Project Manager to oversee the development of a major new hospital building project....
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Senior Accountant
1 month ago
Emeryville, United States LHH Recruitment Solutions Full timeJob DescriptionJob DescriptionLHH Recruitment Solutions is working with one of our clients looking to fill a Senior Accountant job opportunity for the corporate office located in Emeryville, CA. This position is hybrid and will be required to be in-office 2 days a week. The ideal candidate will have 3 years of experience as a Senior Accountant with strong...
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Sr. Strategic Sourcing Manager
2 weeks ago
Emeryville, United States Premier Nutrition Full timeBusiness Unit Overview Premier Nutrition Company (PNC) is one of the fastest-growing companies in the convenient nutrition space, showing clear leadership in the category of protein shakes and protein powders. We make the brands Premier Protein, Dymatize , and PowerBar , which is sold internationally, and we are part of our holding company, BellRing Brands...
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Clinical Data Management Director
2 weeks ago
Emeryville, California, United States Kyverna Therapeutics Full timeJob Description: We are seeking an experienced Clinical Data Management Director to join our team at Kyverna Therapeutics. As a key member of our clinical development team, you will be responsible for leading the clinical data management function, ensuring the quality and integrity of our clinical data. The successful candidate will have a strong background...
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Senior Mechanical Engineer
20 hours ago
Emeryville, United States Enercon Services Full timeOverview Join our team for an exciting engineering role in the data center industry! Craft precise documents, maintain industry knowledge, and ensure high-quality engineering deliverables. Build strong client relationships, collaborate with diverse disciplines, and serve as the Responsible Engineer (RE) for project scope. Take your career to the next level...
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Associate Director, DP Commercial Small Molecule
3 weeks ago
Emeryville, United States BeiGene Full time**General Description:**The Associate Director, DP Commercial Small Molecule in External Supply Quality organization is responsible for ensuring the commercial small molecule products are manufactured, packed, labelled, stored and transported in a controlled way at CMOs that is in accordance with the regulatory expectations and applicable GMP/GDP quality...
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Emeryville, United States Tanium Full timeThe Basics (Hybrid Role, 3 days in office): As a Senior Software Engineer at Tanium, you will build and maintain best-of-breed products as part of a nimble development team. Tanium focuses on a customer engagement model and feedback process to ensure our products are designed the right way from the beginning. When new products ideas are identified, our...
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Emeryville, United States Kyverna Therapeutics Full timeKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the...
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Emeryville, United States Tanium Full timeThe Basics (Hybrid Role, 3 days in office): As a Senior Software Engineer at Tanium, you will build and maintain best-of-breed products as part of a nimble development team. Tanium focuses on a customer engagement model and feedback process to ensure our products are designed the right way from the beginning. When new products ideas are identified, our...
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Senior NetSuite Solution Architect
6 days ago
Emeryville, United States ZipRecruiter Full timeTITLE: NetSuite Senior Solution ArchitectLOCATION: Fully Remote (USA)Groundbreaking advances in synthetic biology achieved at Client X allow us to create products that are better and safer for humans and more sustainable for the planet. The Digital group is charged with creating connected experiences and back-end services to catapult our consumer brands to...
