The Corporate Affairs function seeks to create a positive funding environment for our current and pipeline medicines. Government Affairs, Health Economics and a field-based team of Regional Corporate Affairs Specialists deliver integrated programmes designed to engage at all levels of policy-making, with NHS management and with patient organisations. Our goal is to enable all patients who could benefit from our medicines to be able to receive them.
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Development Field Operations is the team responsible for the execution and implementation of the Amgen global clinical study portfolio within the UK & Ireland. The clinical research involves all study phases and therapeutic areas of drug development within Amgen. For the execution of our clinical programs the Development Operations Group utilises the same operational platform to ensure that a consistently high study execution standard is maintained from Phases 1 to 4.
The department consists of a clinical research services team (Clinical Trial Administrators and Site Contracting/Budgeting Associates), a local study management capability (therapy aligned Clinical Operations Managers), a field based CRA team reporting into a manager, Clinical Field Operations and a dedicated Standards and Training Specialist.
Related information International R&D
The Facilities Management Department is responsible for the buildings that Amgen occupies in the UK and various support services. Our role is to provide a safe and efficient working environment for all employees, and one that enables the business to function effectively. We employ many disciplines to achieve this, including property and space management, building and engineering services maintenance, company car fleet management, health & safety, and contract management of service providers such as catering and security. The Facilities Team work in conjunction with both the International Research & Development and UK/Ireland (Commercial) business groups.
The Finance Department consists of 4 areas:
The team consists of individuals with a wide range of skills - qualified and non qualified accountants, market researchers, business analysts and procurement specialists.
The team exists to provide financial, commercial and analytical support to Amgen Limited and Amgen Ireland Limited. The UK & Ireland’s Accounts Payable, Accounts Receivable and Treasury functions are operated through Amgen International's Shared Service Centre based in the Netherlands.
Human Resources
Human Resources (HR) professionals at Amgen serve as business advisors for our functional areas and as specialists offering expertise in areas including Benefits & Compensation, Staffing, HR Operations, Security, Diversity and Training & Development.
We are encouraged to seek out new challenges to broaden their experience, such as moving between generalist and specialist roles. Whether through staffing, upgrading performance management or designing and implementing leadership development programs, we help to shape the company’s functions and work environment. Amgen HR is seen as having an integral role in helping Amgen achieve it's business objectives whilst working with individual staff members meet their career goals.
Information Systems
The International Development IS Department delivers information systems services to all clients within International Research and Development.
We partner extensively with our peers in European IS, UK IS Customer Services, and our Thousand Oaks Development IS peer groups based in California, to improve our clients’ productivity through business process support and improvement. This is often accomplished via delivery and support of information systems solutions which address the management, logistical and communication needs of Amgen's drug development engine.
Within our group we have multi-dimensional, IS professionals with backgrounds in software development, project management, software and process validation, and technical support. We continue to expand our team with individuals having pharmaceutical industry experience or relevant credentials from other industries with similar IS needs.
Legal
The UK Legal Team within the International Law Group consists of a team of Paralegals reporting to a Zug-based Legal Counsel. The Paralegals have specific geographic and functional responsibilities with the primary focus of providing legal support to Global Study Management, Contracting, Regulatory Affairs and Compliance. The Team works for internal clients, providing advice and training on a variety of legal and regulatory issues. The team is also in charge of creating and updating clinical trial contract templates. Responsibilities further extend to contractual negotiations and the construction, tracking and maintenance of all the required clinical trial contracts as well as the review and approval of Informed Consent Forms.
Medical Department
Amgen’s UK/Ireland Medical Department comprises a number of functions and works across our portfolio of licensed products and pipeline drugs. It delivers support to the organisation in the form of the Regulatory, Pharmacovigilance, Medical Affairs, Medical Information and Development Field Operations, serving both internal and external customers.
Based on a solid understanding of diseases and their current treatments, we aspire to improve people's lives by changing the practice of medicine.
The Medical Affairs team generates scientific and medical data by conducting clinical research and supporting investigator sponsored studies. A field based component of the team, the Regional Medical Liaison Group, conduct medical-scientific communication and education, working closely with opinion leaders in relevant disease areas.
To support a successful market entry and best-possible patient access for new drugs, the Medical Department collaborates closely with our colleagues in Marketing, Sales and Health Economics. For more information on the functions within the Medical Department please refer to separate sections on Regulatory, Pharmacovigilance and Development Field Operations.
Nephrology Business Unit
The UK and Ireland's core business is sales and marketing. The Nephrology Business Unit (NBU) provides drug therapies to patients in hospitals within the NHS and private health sector across all of the UK and Ireland. Our products are Aranesp ® and Mimpara ®.
Typical roles within the NBU include Regional Account Managers, Product Managers and Sales & Marketing Coordinators. Our Regional Account Manager roles have a broad focus in developing our business through operating across primary care, procurement and hospitals within the NHS.
Oncology Business Unit
The UK and Ireland's core business is sales and marketing. The Oncology Business Unit (OBU) provides drug therapies to patients in hospitals within the NHS and private health sector across all of the UK and Ireland. Our products are Neulasta ®, Neupogen ®, Aranesp ® and Vectibix ®.
Typical roles within the OBU include Regional Account Managers, Regional Business Managers, Product & Marketing Managers and Sales & Marketing Coordinators. Our Regional Account Manager roles have a broad focus in developing our business through operating across primary care, procurement and hospitals within the NHS.
Pharmacovigilance
The Pharmacovigilance team provides timely, high quality, unbiased, up-to-date safety information for Amgen products, primarily for external customers such as pharmacists, nurses and doctors. It is also responsible for complying with the legal requirements of the MHRA and IMB for reporting of local and international adverse events observed with Amgen marketed and clinical trial products.
Typical roles in this department team include Drug Safety Executive. Candidates would be expected to have a minimum of an honours degree in a biological science, and to possess strong written and oral communication skills.
Regulatory
The Regulatory Affairs Department provides a crucial link between the company, its products and the regulatory authorities. Within the company, our regulatory professionals must negotiate effectively across a broad spectrum of disciplines, from manufacturing and clinical, to marketing and legal. Externally, we have responsibility for communicating and arbitrating with both the European Medicines Agency (EMEA), national European agencies such as the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and other agencies in the rapidly expanding International territories. The Regulatory Affairs Department plays a pivotal role in putting the case forward to the regulatory authorities that the quality, safety and efficacy testing of the product are appropriate for the label proposed. This role begins right at the drug discovery stage and continues for as long as the drug is on the market.
