Senior Project Manager
il y a 4 jours
In this role, you will ensure the appropriate coordination of multiple functions, i.e. formulation, regulatory affairs, preclinical, clinical, CMC, etc., to effectively execute drug product development. You will draw up binding project development plans based on a pre-approved project schedule matrix and be responsible for ensuring each project remains on schedule and on budget.
Responsibilities
Project Development Strategy
- Establish the overall strategy and implementation process for each project in collaboration with internal teams and/or potential partners, in consistency with the harmonized product development process at Medincell and the standardized project management process
- Establish a project team
- Plan activities with the project team and determine the associated budget
- Determine the necessary resources and include them in the budget
- Evaluate risks and their impacts; put in place mitigation plans
Project follow-up
- Oversee projects in accordance with timetables
- Ensure adherence to objectives and deliverables on time at proper quality
- On a regular basis, prepare and lead regular updates and plan meetings with internal teams and partners
- Write up and coordinate reports for internal and external (partners) use
- Identify bottlenecks and potential problems and undertake actions to resolve them
- Recommend and implement approved plans for urgent issues and establish working groups needed to solve issues
- Provide precise budget forecasts and monitor / ensure adherence to the initial project budget
- Ensure that project data is accurate, up-to-date and accessible
- Establish and oversee the communications plan based on decisions regarding future project approach made at review meetings with the sponsor and the Leadership Team
- Serve as the Project Champion and the leader of meetings with the sponsor and during decision-making meetings
- Consolidate and monitor project termination plans and ensure an optimal transition of the program
Continuous improvement
- Develop metrics / KPIs
- Evaluate projects against the metrics initially established
- Propose process improvements and tools
- Prepare debriefing of the project
Requirements
- Minimum 5 years of relevant work experience in pharmaceutical development, from proof of concept to First in Human clinical as a minimum
- Experience in a project management role
- Good knowledge of drug development processes and regulations
- Scientific background with relevant pharmaceutical science (or equivalent) education
- Experience in international and multidisciplinary teams
- Fluency in English is essential
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