The Associate Director, GCP/GVP Quality Assurance provides senior-level quality oversight for Shionogi’s clinical development and pharmacovigilance activities, ensuring compliance with ICH, FDA, EMA, PMDA, MHRA, and other global regulatory requirements. Serving as the QA representative to assigned study teams and an advisor to PV, this role evaluates processes, practices, documentation, and study plans to identify compliance risks and drive resolution of quality issues.
Quality Assurance Manager (Florham Park, NJ) – Analyze and oversee quality assurance of pharmaceutical product, including quality control practice, CMC (Chemistry, Manufacturing, and Control), and process in all stages of the drug manufacturing, testing, packaging, and documentation, and FDA drug approval submissions, to ensure product quality standards and FDA/ANDA regulatory compliance; Identify, mitigate, and resolve regulatory compliance and quality issues that may affect drug products; Perform batch records review and communicate any adverse findings to approved Contract Manufacturing Organizations (CMO); Perform product quality investigations and participate in the...
The Director, Product and Corporate Communications will report to the Senior Director, Corporate Communications and will lead the development and implementation of integrated Product and Corporate Communications. The individual in this role must be highly collaborative, have experience in the biotech or pharmaceutical industry, have a strong desire to be part of a growth culture, and have proven ability to drive effective communications strategies and programs. This is a contract position. The position will be hybrid and must be able to be in person in Florham Park, NJ. on an as needed basis.
We are seeking an experienced Sr. Manager, GCP QA, to join our team. This role is crucial for ensuring quality oversight of clinical studies and vendor programs, maintaining compliance with ICH GCP and FDA regulatory requirements, and upholding our high standards for data integrity. The ideal candidate will collaborate with clinical study teams and internal departments to assess and mitigate risks associated with vendors.
Reporting to the Senior Director, Consumer Marketing, the Associate Director, Consumer Marketing is responsible for developing and executing consumer marketing strategies for an upcoming launch brand. This role will focus heavily on digital innovation and omnichannel engagement to drive awareness and education. The ideal candidate will bring a strong digital-first mindset, deep understanding of patient journeys, and experience navigating the regulatory landscape of pharmaceutical marketing.
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.
The Associate Director HRIS and Operations will provide functional and technical expertise along with leadership to drive, maintain and optimize our HR Systems and Operations. This role will work closely and collaboratively with key stakeholders (HR Business Partners, HR Total Rewards, Finance & Accounting, Payroll, IT, Legal, Compliance, global HR, etc.) to identify opportunities for automation and reduction of manual processes. This is a hands-on role that will improve HR processes with the use of technology while maintaining compliance with all policies and procedures and federal and state regulations.
The District Manager (DM) is a first-line, field-based sales management role accountable for building a team of primary-care sales representatives. This includes hiring, training and deploying a motivated team with strong customer account management, product, and disease state knowledge who are responsible for generating sales and demand within his/her sales district.
This position focuses on establishing customer relationships, maximizing sales performance, and implementing national sales strategies to...
The Senior Promotional Review Associate (Contractor) will provide operational and coordination support to the U.S. Review Committee (USRC) process for assigned products. This role will assist with preparing promotional materials for review, facilitating meetings, maintaining documentation in Veeva PromoMats, and ensuring efficient workflow execution under the direction of USRC leadership.
This Senior Promotional Review Associate (Contractor) serves as the primary point of...
The Senior Director, Global Epidemiology & Real-World Evidence (RWE) sets and drives the U.S. RWE strategy across therapeutic areas while ensuring alignment with global vision. Serving as a methodological authority, the Senior Director directs large, complex vendor relationships and database investments, integrates RWE across functions, and represents the company externally with regulators, payers, and scientific societies. The role provides leadership to global epidemiology staff and plays a critical role in shaping organizational-level RWE standards, innovation, and external influence.
The Clinical Research Scientist will review and interpret clinical data for query resolution by contacting clinical study site personnel including the principal investigator.
Responsible for authoring, editing, and reviewing complex clinical study documents in collaboration with the Global Medical Monitor and Medical Writers, as well as ensure the accuracy and quality of applicable written deliverables and their compliance with ethical, legal, regulatory, and client standards.
The role also involves writing, editing, reviewing, and compiling complex clinical study documents in collaboration with the Global Medical Monitor and Medical Writers. Collaboratively, ensure accuracy, quality, and compliance with...
This role will support the Regulatory Operations team with the preparation of submission related documentation for electronic submission. The scope of this role includes assisting in document formatting, remediation and quality control (QC) of documentation for submissions to Health Authorities. The role also involves archiving correspondence with Health Authorities, as well as managing documents stored at or retrieved from offsite facilities. The ideal candidate will bring experience with Microsoft Word, Adobe Acrobat, and Veeva RIM.
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.
The District Manager (DM) is a first-line, field-based sales management role accountable for building a team of primary-care sales representatives. This includes hiring, training and deploying a motivated team with strong customer account management, product, and disease state knowledge who are responsible for generating sales and demand within his/her sales district.
This position focuses on establishing customer relationships, maximizing sales performance, and implementing national sales strategies to achieve budget targets. The role requires strong leadership...
The District Manager (DM) is a first-line, field-based sales management role accountable for building a team of primary-care sales representatives. This includes hiring, training and deploying a motivated team with strong customer account management, product, and disease state knowledge who are responsible for generating sales and demand within his/her sales district.
This position focuses on establishing customer relationships, maximizing sales performance, and implementing national sales strategies to...
The District Manager (DM) is a first-line, field-based sales management role accountable for building a team of primary-care sales representatives. This includes hiring, training and deploying a motivated team with strong customer account management, product, and disease state knowledge who are responsible for generating sales and demand within his/her targeted sales district.
This position focuses on establishing customer relationships, maximizing sales performance, and implementing national sales strategies to achieve budget targets. The role requires strong leadership skills to coach and develop team members...
The District Manager (DM) is a first-line, field-based sales management role accountable for building a team of primary-care sales representatives. This includes hiring, training and deploying a motivated team with strong customer account management, product, and disease state knowledge who are responsible for generating sales and demand within his/her sales district.
This position focuses on establishing customer relationships, maximizing sales performance, and implementing national sales strategies to...
The District Manager (DM) is a first-line, field-based sales management role accountable for building a team of primary-care sales representatives. This includes hiring, training and deploying a motivated team with strong customer account management, product, and disease state knowledge who are responsible for generating sales and demand within his/her sales district.
This position focuses on establishing customer relationships, maximizing sales performance, and implementing national sales strategies to...
The District Manager (DM) is a first-line, field-based sales management role accountable for building a team of primary-care sales representatives. This includes hiring, training and deploying a motivated team with strong customer account management, product, and disease state knowledge who are responsible for generating sales and demand within his/her sales district.
This position focuses on establishing customer relationships, maximizing sales performance, and implementing national sales strategies to...
The District Manager (DM) is a first-line, field-based sales management role accountable for building a team of primary-care sales representatives. This includes hiring, training and deploying a motivated team with strong customer account management, product, and disease state knowledge who are responsible for generating sales and demand within his/her sales district.
This position focuses on establishing customer relationships, maximizing sales performance, and implementing national sales strategies to...
The District Manager (DM) is a first-line, field-based sales management role accountable for building a team of primary-care sales representatives. This includes hiring, training and deploying a motivated team with strong customer account management, product, and disease state knowledge who are responsible for generating sales and demand within his/her sales district.
This position focuses on establishing customer relationships, maximizing sales performance, and implementing national sales strategies...
The District Manager (DM) is a first-line, field-based sales management role accountable for building a team of primary-care sales representatives. This includes hiring, training and deploying a motivated team with strong customer account management, product, and disease state knowledge who are responsible for generating sales and demand within his/her sales district.
This position focuses on establishing customer relationships, maximizing sales performance, and implementing national sales strategies to...
The District Manager (DM) is a first-line, field-based sales management role accountable for building a team of primary-care sales representatives. This includes hiring, training and deploying a motivated team with strong customer account management, product, and disease state knowledge who are responsible for generating sales and demand within his/her sales district.
This position focuses on establishing customer relationships, maximizing sales performance, and implementing national sales strategies to achieve budget targets. The role requires strong leadership...
The District Manager (DM) is a first-line, field-based sales management role accountable for building a team of primary-care sales representatives. This includes hiring, training and deploying a motivated team with strong customer account management, product, and disease state knowledge who are responsible for generating sales and demand within his/her sales district.
This position focuses on establishing customer relationships, maximizing sales performance, and implementing national sales strategies to...
The District Manager (DM) is a first-line, field-based sales management role accountable for building a team of primary-care sales representatives. This includes hiring, training and deploying a motivated team with strong customer account management, product, and disease state knowledge who are responsible for generating sales and demand within his/her sales district.
This position focuses on establishing customer relationships, maximizing sales performance, and implementing national sales strategies to achieve budget targets. The role requires strong leadership skills to coach...
The District Manager (DM) is a first-line, field-based sales management role accountable for building a team of primary-care sales representatives. This includes hiring, training and deploying a motivated team with strong customer account management, product, and disease state knowledge who are responsible for generating sales and demand within his/her sales district.
This position focuses on establishing customer relationships, maximizing sales performance, and implementing national sales strategies to achieve budget targets. The role requires strong leadership skills to coach...
The Associate Director, Commercial Data Operations will lead the strategy, governance, and execution of Shionogi’s commercial data assets to ensure timely, accurate, and compliant data availability for business insights. Acting as the primary liaison between external data providers (IQVIA, Symphony, Veeva, etc.) and internal stakeholders (Commercial, Market Access, Medical, Finance, IT, Analytics), this role will drive operational excellence in data acquisition, integration, quality, and delivery.
This role will help shape and advance Shionogi’s Commercial Data Management strategy,...
The Director, US Regulatory Advertising and Promotion is a senior individual contributor responsible for regulatory strategy related to promotional and scientific exchange materials across assigned portfolios or therapeutic areas, spanning all stages of the product lifecycle. As the internal subject matter expert on FDA advertising and promotion regulations, this role ensures compliance while enabling innovative, science-based communication that supports commercial and corporate objectives. The Director will collaborate extensively with cross-functional teams and serve as the primary liaison with the Office of Prescription Drug Promotion (OPDP) for assigned products, while also driving process improvements and supporting...
The contractor will provide temporary QA support to maintain quality and compliance oversight of sterile pharmaceutical products manufactured by third-party partners. The focus will be on batch release, issue resolution, and regulatory compliance for the duration of the assignment. This role will ensure continuity in QA oversight without disruption to supply or compliance commitments.
The Senior Director, Global Commercial Lead (GCL) will work closely with our Japan HQ to shape product development plans and implement global commercialization strategies in multiple therapeutic areas.
The GCL is a high visibility role to lead projects of considerable value to the organization. As GCL, you will direct and coordinate cross-functional teams dispersed across Japan, US and Europe to create value for Shionogi and the patients and caregivers we serve. You will lead formation, alignment and execution of global strategies, optimizing the life cycle of the product. This will be achieved by providing global perspective and strategic direction at each step of the...
The Area Business Lead for LTC is a first-line field sales leadership role accountable for building and leading a high-performing team of LTC Account Managers across a multi-state territory and managing all operations related to the sales force in a defined region of the US.
The role will support the pending launch of ensitrelvir, for a novel 3CL protease inhibitor for the prevention of SARS-CoV-2 infection for the US as part of a long-term care sales teamand will be directly responsible for field...
The Area Business Lead for LTC is a first-line field sales leadership role accountable for building and leading a high-performing team of LTC Account Managers across a multi-state territory and managing all operations related to the sales force in a defined region of the US.
The role will support the pending launch of ensitrelvir, for a novel 3CL protease inhibitor for the prevention of SARS-CoV-2 infection for the US as part of a long-term care sales teamand will be directly responsible for field...
Support the Regulatory Affairs (Executive Director) in developing and executing regulatory strategies for antiviral programs globally or within specific regions
