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The Manager, Regulatory Affairs – Global Development supports development and lifecycle regulatory activities across assigned products and clinical programs. This role serves as the Regulatory Affairs lead for assigned projects, owning regulatory deliverables and acting as a key point of contact for cross-functional teams.
The individual operates with a high degree of autonomy for assigned responsibilities, applying regulatory knowledge and critical thinking to interpret data, ensure compliance, and guide regulatory activities with minimal direction. This role contributes to regulatory strategy execution and proactively identifies risks, drives solutions, and...
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This role will lead in the preparation and submission of electronic regulatory documents through the FDA, EMA, MHRA, and Health Canada Electronic Submission Gateways (ESG,), as well as prepare and file non-eCTD submissions, to ensure compliance with applicable laws and regulations. The scope of this role includes publishing regulatory documents, managing document tracking and version control, maintaining a thorough understanding of regulatory requirements, collaborating with cross-functional teams, and identifying opportunities for process improvements. In addition to these standard publishing requirements, the Senior Regulatory Operations Associate will bring project management skills and technical...
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Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global pharmaceutical company with a long history of bringing innovative medicines to patients. Building on its leadership in infectious disease, Shionogi Inc. is establishing a best-in-class rare disease franchise. The company’s growing rare disease team is helping shape the future of RADICAVA® (edaravone) for the amyotrophic lateral sclerosis (ALS) community. In the United States, RADICAVA® has an established legacy, with the injectable formulation launched in 2017 and the oral suspension introduced in 2022. Building...
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Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global pharmaceutical company with a long history of bringing innovative medicines to patients. Building on its leadership in infectious disease, Shionogi Inc. is establishing a best-in-class rare disease franchise. The company’s growing rare disease team is helping shape the future of RADICAVA® (edaravone) for the amyotrophic lateral sclerosis (ALS) community. In the United States, RADICAVA® has an established legacy, with the injectable formulation launched in 2017 and the oral suspension introduced in 2022. Building...
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Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global pharmaceutical company with a long history of bringing innovative medicines to patients. Building on its leadership in infectious disease, Shionogi Inc. is establishing a best-in-class rare disease franchise. The company’s growing rare disease team is helping shape the future of RADICAVA® (edaravone) for the amyotrophic lateral sclerosis (ALS) community. In the United States, RADICAVA® has an established legacy, with the injectable formulation launched in 2017 and the oral suspension introduced in 2022. Building...
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The Promotional Materials Review Committee (PMRC) Manager is responsible for committee review activities in support of external commercial and corporate communications. The incumbent will provide committee review requirements to corporate and commercial functional project managers and external vendors generating promotional pieces while leading a cross-functional PMRC that assesses risks of promotional materials including patient, health care provider (HCP), disease state educational, sales training and press materials as well as other external communications. Within the PMRC, the incumbent will provide governance and scheduling of committee activities for developing promotional draft...
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The temporary contractor will assist the Regulatory Operations team with:
- The preparation of submission-related tasks for various products. This assignment involves supporting the preparation, remediation, and quality control (QC) of documentation for submissions to Health Authorities.
- The archiving of Health Authority (HA) correspondences for various products This includes to and from the HA.
- The archiving of submissions and correspondences from applications acquired by...
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The Director, Insights & Analytics, COVID will serve as the analytical lead for a novel oral antiviral for COVID-19 Post-Exposure Prophylaxis (PeP) that is expected to launch in the near future. Reporting to the Senior Director, Insights & Analytics, Infectious Disease Franchise, this role is a highly visible, hands-on position with regular exposure to senior stakeholders. This individual will shape brand strategy, influence investment decisions, and establish a cohesive, insight-driven view of performance across the organization. The role requires a leader who can personally execute advanced analytics while operating as a trusted thought partner to cross-functional stakeholders. ...
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Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global pharmaceutical company with a long history of bringing innovative medicines to patients. Building on its leadership in infectious disease, Shionogi Inc. is establishing a best-in-class rare disease franchise. The company’s growing rare disease team is helping shape the future of RADICAVA® (edaravone) for the amyotrophic lateral sclerosis (ALS) community. In the United States, RADICAVA® has an established legacy, with the injectable formulation launched in 2017 and the oral suspension introduced in 2022. Building...
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The Associate Sales Representative/Sales Representative (SR) for Primary Care is responsible for promoting and selling primary care product(s) to healthcare providers, driving sales performance in alignment with business goals within the assigned territory. This includes driving demand, clinical education and sales by developing, coordinating, and implementing a strategic business plan for Primary Care Physicians.
The position reports to the District Manager and will collaborate closely with Marketing, Market Access, and other internal partners, as appropriate, to drive sales results. The span of coverage will be within the Flint, Michigan...
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The QA Product Manager (Sterile Products) plays a critical role in ensuring the quality, safety, and regulatory compliance of sterile pharmaceutical products manufactured by third-party CMOs. This position partners cross-functionally with global internal teams and external manufacturers to ensure effective implementation of quality systems build and maintain robust quality systems, support sterility assurance and contamination control strategies, and uphold regulatory expectations. This role is accountable for QA activities across the product lifecycle, including technology...
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The Associate Sales Representative/Sales Representative (SR) for Primary Care is responsible for promoting and selling primary care product(s) to healthcare providers, driving sales performance in alignment with business goals within the assigned territory. This includes driving demand, clinical education and sales by developing, coordinating, and implementing a strategic business plan for Primary Care Physicians.
The position reports to the District Manager and will collaborate closely with Marketing, Market Access, and other internal partners, as appropriate, to drive sales results. The span of coverage will be...
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Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global pharmaceutical company with a long history of bringing innovative medicines to patients. Building on its leadership in infectious disease, Shionogi Inc. is establishing a best-in-class rare disease franchise. The company’s growing rare disease team is helping shape the future of RADICAVA® (edaravone) for the amyotrophic lateral sclerosis (ALS) community. In the United States, RADICAVA® has an established legacy, with the injectable formulation launched in 2017 and the oral suspension introduced in 2022. Building...
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The Senior Counsel Contracts and Transactions will provide experienced, hands-on legal support focused on drafting, reviewing, negotiating, and advising on a high volume of complex commercial and operational agreements. This role is intended to provide legal support for increased activities in business development, product and company diligence and acquisitions, transaction support and post-acquisition/merger integration and on-going legal support. The attorney filling this role will collaborate closely with Global Legal and Compliance teams (including participating in weekly virtual meetings...
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Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global pharmaceutical company with a long history of bringing innovative medicines to patients. Building on its leadership in infectious disease, Shionogi Inc. is establishing a best-in-class rare disease franchise. The company’s growing rare disease team is helping shape the future of RADICAVA® (edaravone) for the amyotrophic lateral sclerosis (ALS) community. In the United States, RADICAVA® has an established legacy, with the injectable formulation launched in 2017 and the oral suspension introduced in 2022. Building on that strong foundation,
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The Associate Sales Representative/Sales Representative (SR) for Primary Care is responsible for promoting and selling primary care product(s) to healthcare providers, driving sales performance in alignment with business goals within the assigned territory. This includes driving demand, clinical education and sales by developing, coordinating, and implementing a strategic business plan for Primary Care Physicians.
The position reports to the District Manager and will collaborate closely with Marketing, Market Access, and other internal partners, as appropriate, to drive sales results. The span of coverage will be within the Portland, OR...
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The Associate Sales Representative/Sales Representative (SR) for Primary Care is responsible for promoting and selling primary care product(s) to healthcare providers, driving sales performance in alignment with business goals within the assigned territory. This includes driving demand, clinical education and sales by developing, coordinating, and implementing a strategic business plan for Primary Care Physicians.
The position reports to the District Manager and will collaborate closely with Marketing, Market Access, and other internal partners, as appropriate, to drive sales results. The span of coverage will be within the Poughkeepsie, NY...
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The Associate Sales Representative/Sales Representative (SR) for Primary Care is responsible for promoting and selling primary care product(s) to healthcare providers, driving sales performance in alignment with business goals within the assigned territory. This includes driving demand, clinical education and sales by developing, coordinating, and implementing a strategic business plan for Primary Care Physicians.
The position reports to the District Manager and will collaborate closely with Marketing, Market Access, and other internal partners, as appropriate, to drive sales results. The span of coverage will be within the Tucson, AZ...
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The Associate Sales Representative/Sales Representative (SR) for Primary Care is responsible for promoting and selling primary care product(s) to healthcare providers, driving sales performance in alignment with business goals within the assigned territory. This includes driving demand, clinical education and sales by developing, coordinating, and implementing a strategic business plan for Primary Care Physicians.
The position reports to the District Manager and will collaborate closely with Marketing, Market Access, and other internal partners, as appropriate, to drive sales results. The span of coverage will be within the South Boston, MA...
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The Associate Sales Representative/Sales Representative (SR) for Primary Care is responsible for promoting and selling primary care product(s) to healthcare providers, driving sales performance in alignment with business goals within the assigned territory. This includes driving demand, clinical education and sales by developing, coordinating, and implementing a strategic business plan for Primary Care Physicians.
The position reports to the District Manager and will collaborate closely with Marketing, Market Access, and other internal partners, as appropriate, to drive sales results. The span of coverage will be within the San Jose, CA...
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The Associate Sales Representative/Sales Representative (SR) for Primary Care is responsible for promoting and selling primary care product(s) to healthcare providers, driving sales performance in alignment with business goals within the assigned territory. This includes driving demand, clinical education and sales by developing, coordinating, and implementing a strategic business plan for Primary Care Physicians.
The position reports to the District Manager and will collaborate closely with Marketing, Market Access, and other internal partners, as appropriate, to drive sales results. The span of coverage will be within the Poughkeepsie, NY...
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The Associate Sales Representative/Sales Representative (SR) for Primary Care is responsible for promoting and selling primary care product(s) to healthcare providers, driving sales performance in alignment with business goals within the assigned territory. This includes driving demand, clinical education and sales by developing, coordinating, and implementing a strategic business plan for Primary Care Physicians.
The position reports to the District Manager and will collaborate closely with Marketing, Market Access, and other internal partners, as appropriate, to drive sales results. The span of coverage will be within the North Boston, MA...
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The Financial Analyst will support the Commercial and G&A finance business partners in finance activities such as month-end close and accruals, invoice generation and processing, data validation of budget and LE and administration of the company’s financial planning tool. This position will assist with financial reporting and analysis activities. The ideal candidate is a team player who is motivated to learn and contribute to a Finance organization in a growing company
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The KAM position is focused on establishing access and demand for a novel hospital antibiotic product to hospitals and hospital systems within an assigned territory. This includes educating formulary decision makers, key stakeholders, and clinicians on the clinical benefits of the product and establishing and gaining formulary adoption within the institutional IV antibiotic space. The KAM will be responsible for formulary access and sales at the top institutions in the U.S.
KAMs are responsible for calling on a variety of targeted healthcare professionals within the institutional setting, planning, implementing and taking ownership of their territory plans to...
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Shionogi is committed to incorporating the voice of the patient into its clinical development programs. The Director/Senior Director of COA Strategy, Development & Implementation is responsible for developing a given asset’s COA strategy to ensure patient‑centered, regulatory‑acceptable, and value‑laden endpoints are incorporated into the development program. This role provides strategic leadership to cross-functional study teams to ensure COA measures are fit-for-purpose to inform patient-physician treatment strategies, health technology assessments, and payers’ willingness to pay. The successful candidate will have deep subject matter expertise in COA measurement sciences, excellent communication skills, and demonstrated experience in...
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We are seeking a Senior Manager/Associate Director, Institutional Training to support the training and development for two sales teams: the Anti‑Infective Hospital Sales Team and the Long‑Term Care (LTC) Sales Team. This role will oversee training for Fetroja, a novel antibiotic promoted by the hospital team, and will play a key role in preparing the LTC team for the launch of a novel 3CL protease inhibitor for the prevention of SARS‑CoV‑2 infection.
The Senior Manager/Associate Director, Institutional Training will execute training strategies and deliver key initiatives including new‑hire training, supplemental and...
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The Senior Manager, Pharmaceutical Sciences applies broad pharmaceutical sciences and CMC expertise to develop and maintain commercial products that are safe, effective, compliant, and robust across the product lifecycle. This role will provide technical leadership for an oral suspension product and a sterile injectable product, including formulation/process development, technology transfer, external manufacturing (CDMO/CMO) oversight, investigations, and post-approval lifecycle management.
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The Supplier Manager position is responsible for managing the implementation and execution of the sourcing strategy for assigned commodities and/or products, managing the products within the contract requirements to ensure product supply, ensuring ongoing cross-functional coordination, and delivering annual improvements in total cost, quality, and service. This position is responsible for contributing to the process of sourcing strategy development, supplier selection, negotiation, and strategy refinement. Additionally, this position will support the development and implementation of strong...
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The KAM position is focused on establishing access and demand for a novel hospital antibiotic product to hospitals and hospital systems within an assigned territory. This includes educating formulary decision makers, key stakeholders, and clinicians on the clinical benefits of the product and establishing and gaining formulary adoption within the institutional IV antibiotic space. The KAM will be responsible for formulary access and sales at the top institutions in the U.S.
KAMs are responsible for calling on a variety of targeted healthcare professionals within the institutional setting, planning, implementing and taking ownership of their territory plans to...
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The Medical Science Liaison (MSL) is a field-based representative of the Medical Affairs Organization that supports and represents Shionogi Inc and its products with, and to, key opinion leaders (KOLs), clinicians, institutions, and professional organizations. This includes relationship building and management of KOLs providing for meaningful scientific exchange at national, regional and local levels in both academic and clinical practice settings. The incumbent addresses the specific needs of healthcare professionals (HCPs) by responding to unsolicited requests for information about our marketed and developing products.
As a clinical and scientific expert on the...
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The Medical Science Liaison (MSL) is a field-based representative of the Medical Affairs Organization that supports and represents Shionogi Inc and its products with, and to, key opinion leaders (KOLs), clinicians, institutions, and professional organizations. This includes relationship building and management of KOLs providing for meaningful scientific exchange at national, regional and local levels in both academic and clinical practice settings. The incumbent addresses the specific needs of healthcare professionals (HCPs) by responding to unsolicited requests for information about our marketed and developing products.
As a clinical and scientific expert on the...
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Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global pharmaceutical company with a long history of bringing innovative medicines to patients. Building on its leadership in infectious disease, Shionogi Inc. is establishing a best-in-class rare disease franchise. The company’s growing rare disease team is helping shape the future of RADICAVA® (edaravone) for the amyotrophic lateral sclerosis (ALS) community. In the United States, RADICAVA® has an established legacy, with the injectable formulation launched in 2017 and the oral suspension introduced in 2022. Building...
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Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global pharmaceutical company with a long history of bringing innovative medicines to patients. Building on its leadership in infectious disease, Shionogi Inc. is establishing a best-in-class rare disease franchise. The company’s growing rare disease team is helping shape the future of RADICAVA® (edaravone) for the amyotrophic lateral sclerosis (ALS) community. In the United States, RADICAVA® has an established legacy, with the injectable formulation launched in 2017 and the oral suspension introduced in 2022. Building...
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The Associate Director, Government Operations will report to the Senior Director, Government Operations and will be responsible for technical and program management activities related to Shionogi’s US Government contracts, including partnerships with agencies such as BARDA, NIH, and the Department of Defense (DOD). This role serves as the primary liaison with internal teams and government agencies in an alliance management capacity, ensuring alignment on program deliverables, budgets, and compliance reporting. Utilizing a robust understanding of and experience with pharmaceutical development and manufacturing, the Associate Director leads efforts of cross functional teams to successfully execute complex, multi-year agreements...
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The QA Product Manager is responsible for ensuring the quality and compliance of pharmaceutical products (active pharmaceutical ingredients and/or drug products) manufactured by third-party contractors/suppliers (CMOs). This role involves collaborating with cross-functional teams (regional and global), including external manufacturers, Supply Chain, Regulatory Affairs, and Pharmaceutical Sciences, to establish robust quality systems, implement sterility assurance practices including effective contamination control strategies, and maintain adherence to regulatory guidelines. The QA Product Manager will lead quality assurance efforts, review and disposition batches, conduct audits, may and drive continuous improvement initiatives to ensure the...
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The Area Business Lead (ABL) is responsible for leading, coaching, hiring and developing a highly talented team of hospital Key Account Managers (KAMs) who interface directly with Health Care Professionals and other stakeholders within the institutional setting. This role includes leading a motivated team with strong account management acumen, product, and disease state knowledge who are responsible for gaining optimal access for assigned products within his/her targeted accounts.
In addition, through a mix of strong business acumen, leadership skills and relationship building, the ABL is accountable for meeting or exceeding...
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The Area Business Lead (ABL) is responsible for leading, coaching, hiring and developing a highly talented team of hospital Key Account Managers (KAMs) who interface directly with Health Care Professionals and other stakeholders within the institutional setting. This role includes leading a motivated team with strong account management acumen, product, and disease state knowledge who are responsible for gaining optimal access for assigned products within his/her targeted accounts.
In addition, through a mix of strong business acumen, leadership skills and relationship building, the ABL is accountable for meeting or exceeding...
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The Director/Senior Director, Scientific Communications is a strategic leader within U.S. Medical Affairs team responsible for developing and executing strategies to communicate scientific data and medical education and information to internal and external stakeholders. This role has strategic ownership of the scientific narrative across publications, congresses, field medical materials, and digital/omnichannel channels across all therapeutic areas. The position has leadership, budget, and governance accountability and operates as part of the U.S. Medical Leadership Team. This position oversees the planning, creation, and dissemination of medical information and scientific content to diverse audiences, ensuring accuracy, compliance,...
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The Director | Senior Director of Global Healthcare Value & Access (gHCVa), Contractor is responsible for developing and operationalizing relevant strategies for pipeline assets in development focused in orphan and rare diseases. The gHCVa Director | Senior Director will be responsible to ensure the asset in development targets the area of highest unmet need.
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The Area Business Lead (ABL) is responsible for leading, coaching, hiring and developing a highly talented team of hospital Key Account Managers (KAMs) who interface directly with Health Care Professionals and other stakeholders within the institutional setting. This role includes leading a motivated team with strong account management acumen, product, and disease state knowledge who are responsible for gaining optimal access for assigned products within his/her targeted accounts.
In addition, through a mix of strong business acumen, leadership skills and relationship building, the ABL is accountable for meeting or exceeding...
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The Senior Medical Director, Global Medical Affairs (Virology) provides global medical/scientific leadership for assigned assets, serving as a subject matter expert and strategic partner across cross-functional teams. This is a global individual contributor role with asset-level accountability, responsible for executing medical strategy in alignment with global therapeutic area and global medical affairs strategies.
The role has primary responsibility for virology assets, with flexibility to expand as the portfolio evolves. The Senior Medical Director partners with Global Medical Affairs leadership and regional teams to support Medical Affairs objectives, while...
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The Sales Representative (SR) for Primary Care is responsible for promoting and selling primary care product(s) to healthcare providers, driving sales performance in alignment with business goals within the assigned territory. This includes driving demand, clinical education and sales by developing, coordinating, and implementing a strategic business plan for Primary Care Physicians.
The position reports to the District Manager and will collaborate closely with Marketing, Market Access, and other internal partners, as appropriate, to drive sales results. The span of coverage will be within the Northern Phoenix, AZ...
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The Sales Representative (SR) for Primary Care is responsible for promoting and selling primary care product(s) to healthcare providers, driving sales performance in alignment with business goals within the assigned territory. This includes driving demand, clinical education and sales by developing, coordinating, and implementing a strategic business plan for Primary Care Physicians.
The position reports to the District Manager and will collaborate closely with Marketing, Market Access, and other internal partners, as appropriate, to drive sales results. The span of coverage will be within the Santa Clarita, CA...
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The Sales Representative (SR) for Primary Care is responsible for promoting and selling primary care product(s) to healthcare providers, driving sales performance in alignment with business goals within the assigned territory. This includes driving demand, clinical education and sales by developing, coordinating, and implementing a strategic business plan for Primary Care Physicians.
The position reports to the District Manager and will collaborate closely with Marketing, Market Access, and other internal partners, as appropriate, to drive sales results. The span of coverage will be within the Northern San Francisco,...
