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At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Senior Global Report Publishing Manager will be responsible for the oversight of all Global report publishing activities assigned to the Global Regulatory Operations team. This will include the management of staff activities such as project assignment and individual staff development with the scope of annual objective development for career progression.
They also are responsible for the development and overall direction of the publishing team, ensuring that the support provided to business stakeholders within the organization is maintained, along with the high standards expected from all the related deliverables.
All systems and tools relating specifically to the publishing of reports outlined below, will be monitored by the Senior Global Report Publishing Manager, who will have direct communication with the appropriate internal systems and IT contacts to ensure that the maintenance, and upgrade of the software is in line with industry standards and compliance.
The Global Report Publishing Manager should have a detailed knowledge of Report Publishing processes and the requirements across regions for different report types (e.g. DSUR, PSUR, IMPD, CSR, NCSR etc.). They are responsible for managing and facilitating communications to internal business stakeholders who provide content to the Publishing team members.
They will also be required to communicate with identified stakeholders to forecast upcoming work, discuss, agree and implement new processes, and highlight recurring issues and work to resolve them. Another aspect of the role will be the capture, maintenance and delivering of metrics to the Head of Departments highlighting effective planning, resourcing, process improvement and leading other publishing related projects as required.
Management of team members and resource within the GRP team 20%
Act as GRP Lead for key projects and initiatives within the group and with external stakeholders which includes publishing activity when required and ensuring alignment with local SOPs/SWPs and guidance. 30%
Represent GRO as a senior member of the GRP organization on key stakeholders' meetings related to Publishing. 10%
Accountable for GRP workload and resource forecasting and tracking ensuring timely and effective communication. 10%
Responsible for the maintenance, and delivery of key publishing metrics to benefit departmental effectiveness. 10%
Contribute to departmental effectiveness and efficiency by managing and evaluating processes and proposing solutions based on experience and awareness and communicating process changes. 10%
Expected to have direct communication with internal Systems & IT team support leads in regards to publishing software to ensure that the appropriate tools are in place, maintained and upgraded when necessary. 10%
The candidate should have a Bachelor's degree and/or a minimum of 8 years experience working in the Pharmaceutical industry, including minimum of 5 year experience of publishing tools, document management systems and guidance related to report publishing is a must. Awareness of regional requirements for report publishing in the EU and Japan is also beneficial, but not mandatory.
Organization - able to effectively manage multiple tasks across a day. Should be able to evaluate current processes and look to continuously improve the resource and time taken for day to day tasks.
Communication skills are required to build relationships across multiple departments and effectively plan and manage work coming from multiple areas. The role requires communication of status of important tasks to senior people in the organization. As such, the quality and detail in communications is as important as the frequency and accuracy.
Technical Knowledge - serves as SME across a number of processes and systems with key accountability for the delivery of high quality output from those systems or processes. They should have advanced technical understanding of multiple systems and should be able to easily adapt to new processes and systems. A good knowledge of Document Management Systems, Regulatory Tracking, the Microsoft Office suite, Sharepoint and Publishing tools is beneficial.
Leadership - Support direct reports or team members with guidance, demonstrates leadership through effective communication, through supportive engagement in projects and activities helps see things through to completion, ensures effort and resource is targeted towards value added initiatives. As a Senior Manager will be expected to lead with vision and proactively propose improvements to business processes where more efficient strategies can be in place.
The Global Report Publishing Senior Manager will have to support multiple projects with sometimes changing priorities. Also, as key contributors to the Global Operations goals, the Senior Manager should aim to have an awareness of the ever changing landscape within Regulatory Affairs and keep on top of new systems, processes and guidance's that are released. Attention to detail and delivery of high quality of work is equally important as our output gets inputted directly to submissions which are viewed by the Health Authorities. The Systems and Publishing group are a growing and developing team and would suit someone with an interest in developing and improving processes in an organization.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
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