Mission pourvue
Descriptif de la mission
Project management responsibilities
- Facilitate a cross functional CMC sub team, in charge of the set-up of clinical studies and which includes
operational quality assurance, clinical packaging and distribution for internal projects and CDMO
management for outsourced projects
- Represent GCSM within clinical study team meetings and ensure seamless alignment with clinical trials
milestones (timelines, study design assumptions, recruitments assumptions etc)
- Define with its sub team the project scope and objectives while ensuring technical feasibility
- Develop with its sub team comprehensive project plans to ensure on time supply to patients and avoid
IMPs stock out
- Validate the strategy with the Clinical Supply Chain Therapeutic Area Lead
- Develop strong collaboration with Global Regulatory Affairs and CMC Regulatory teams to ensure
alignment of regulatory strategy (submission filing, product references to be used)
- Evaluate impact of changes to the project scope, project schedule, and project costs
- Facilitate the sub team to solve complex challenges and provide mitigation plans in a timely manner to
meet the business needs
- Escalate challenges / issues to management when needed
- Measure performance using appropriate project management tools and techniques
Project management responsibilities
- Facilitate a cross functional CMC sub team, in charge of the set-up of clinical studies and which includes
operational quality assurance, clinical packaging and distribution for internal projects and CDMO
management for outsourced projects
- Represent GCSM within clinical study team meetings and ensure seamless alignment with clinical trials
milestones (timelines, study design assumptions, recruitments assumptions etc)
- Define with its sub team the project scope and objectives while ensuring technical feasibility
- Develop with its sub team comprehensive project plans to ensure on time supply to patients and avoid
IMPs stock out
- Validate the strategy with the Clinical Supply Chain Therapeutic Area Lead
- Develop strong collaboration with Global Regulatory Affairs and CMC Regulatory teams to ensure
alignment of regulatory strategy (submission filing, product references to be used)
- Evaluate impact of changes to the project scope, project schedule, and project costs
- Facilitate the sub team to solve complex challenges and provide mitigation plans in a timely manner to
meet the business needs
- Escalate challenges / issues to management when needed
- Measure performance using appropriate project management tools and techniques
Critères requis
Education / Certifications:
• Pharmacist, engineer or university graduate (BAC+5) with a postgraduate degree in "health industry"
Experience:
• Minimum 5 experience in an equivalent job in the Pharmaceutical Industry with a significant
international exposure
Languages:
• Proficient in French and English
- Experience and knowledge on handling large and complex clinical trials (preferred)
- Good communication skills / networking
- Experience in project management
- Team player with ability to work in a matrix and global environment
- Strong organizational skills