project manager
4 the last 157 days, recently 2023-04-20
Responsibility
- publishing Project Manager
- here at Ipsen we believe that patients cannot wait – for suitable treatment, for support, for awareness
- ipsen is a rapidly growing global biopharmaceutical company focused on innovation and specialty care
Show more +51 - slough, Berkshire, UK SL1 3XE
- capture, simplify and structure existing data for many areas
- working within the Ipsen Regulatory department
- help teams to visualize them
- lead project of simplification and optimization
- the current open position is to support marketed assets which represent significant organisational value
- train employees on Data good practices
- the successful applicant will be a great communicator, and self-starter
- to utilise technical expertise in publishing software for electronic submissions
- you will be a highly visible pivot point
- lead Digital projects
- input to Regulatory submissions
- creation of binders in electronic Document Management System for all submissions under his/her responsibility
- to be considered for the role, you will have a degree, or equivalent, in a science or science related discipline
- publishing or publishing coordination of regulatory dossiers in consultation with functional area representatives and key stakeholders
- ipsen’s goal is to launch one significant product or indication per year, every year, which would be facilitated by transforming R&D, Franchise and TechOps into an even higher performing organization with the ultimate goal of leaving no patient behind
- advance knowledge of SQL, Python and R software preferred
- green Belt certified as minimum; Black belt certification preferred
- partnering with workstream leads and functional reps to ‘pressure-test’ assumptions and function planning to support the workstream plans
- the main mission of the Global Project Manager is to work in collaboration with the Asset Operation Lead and the Asset Team members to develop, implement and manage strategic sub-team plans and its associated budget , to ensure that a consistent project risk management methodology is applied at the sub-team level to proactively identify project risks and opportunities together with contingencies and to use learning and experience from current, previous projects, competitor benchmarking and from the network of Global Project Managers to support successful delivery
- ipsen’s goal is to launch one significant product or indication per year, every year, which will be facilitated by transforming R&D, Franchise, Medical Affairs and Industrial into an even higher performing organization – the Asset Centric Model - with the ultimate goal of leaving no patient behind
- are you looking for an opportunity to be part of a global Operational Excellence leadership team?
- our aim is to make a sustainable difference by significantly improving patients’ health and quality of life through differentiated and innovative medicines in oncology, neurosciences, and rare diseases
- A sub-team is defined as a cross functional team accountable for concrete asset deliverables such as IMP , NDA or could be all activities related to the development of the asset in one indication / population
- to better meet our future needs, this Global R&D Project Manager will report into the asset Operation Lead and will be responsible for leading projects pertaining to two Assets
- delivery of dossiers that fulfil Competent Authorities requirements and pass internal quality and formal validation checks
- ipsen Wrexham is a dynamic manufacturing plant with a strong culture of excellence and wellbeing, with a focus on taking our capability to the next level
- mastery on Office 365 , Minitab or Jmp
- to assist the Publishing team in project managing the electronic assembly / compilation, publishing and quality control of regulatory submissions, in electronic or paper format, in line with publishing and strategic planning
- promote/Communicates on publishing process/timeline with RA community, and contributes to the publishing planning in view of a smooth publishing execution
- you will closely partner with the Asset Operation Lead or sub-team leads to serve as the central points of contact for the team / sub-team members to enable the successful operational delivery of the program
- these projects will involve a high level of engagement across a number of work streams including but not be limited to clinical development, CMC, Regulatory and Commercial activities
- delivery of published output to GRA or LRAs or Service Provider
- as OE Project Manager, you will lead Operational Excellence & Data projects at group level, be responsible for the data driven performance operating systems, and foster the training, coaching, sharing and benchmarking systems within the community
- data Architecture and Analysts notion will be a plus
- to promote processes and best practices within Global Regulatory Affairs and throughout the authoring communities, whether internal or external to the company and within all functions
- publishing activities
- submission of dossiers through agency portals , if not handled by RA stakeholders
- you are the right hand of the AOL ensuring that sub-teams serve the asset and operate in alignment with asset strategy and being able to cover AOL at the core team level
- maintains the planning of publishing
- interacts with the Service Provider to ensure resources are available to complete own publishing in line with planning
- closely and proactively monitor the execution of sub-team plans, measure results, communicate deviations/
- attends any RA project management meeting to be updated of any regulatory activity in relation to allocated products, designs a publishing strategy for the dossiers
- quality control of the published output or interacts with the Service Provider to ensure all publishing steps are performed steps of publishing performed by Service Provider)
- document Specialist
- partner with sub-team lead and functional reps to ‘pressure-test’ assumptions and function planning to supportthe sub-teamplans
- maintains a continuous flow of information to and from Regulatory Data Coordinator, GRA teams and LRAs in particular with regards to publishing activities
- defining the interdependent workstream deliverables aligned with Global Asset Plan and ensures that quality, risk, cost, time are managed to enable delivery of project milestones and objectives on time and on budget
- contributes to the improvement of publishing process and Regulatory processes in performing pilot tests
- assists the regulatory system owners with their system enhancement projects
- validating the technical integrity of the workstream plan ensuring that the technical data is reviewed and discussed at the workstream team meeting for appropriate decision and recommendation to the Asset Teams on follow-up actions
Requirements
- understanding of global regulatory procedures and associated technical requirements
- high level skills standard software packages such as Adobe Acrobat. Lorenz eValidator and publishing tool
- experience in use of the electronic Document Management System
Show more +2 - at least 8 years of experience in the global dossier assembly and production, including expertise on dossier assembly and production, including experience of electronic document and publishing systems
- IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships
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