Mission principale
✓ Under the oversight of the Medical Director, you contribute:
- in setting-up of global medical pre-launch activities on glioma
- to the development of MSL training materials on Vorasidenib
- proactively to coordinate global/local/network animation to address country medical strategy needs
- to review medical scientific publications & information in relation with the domain
✓ Under the oversight of the Evidence Generation Manager, autonomous & proactive contribution of the programs, from conception to realization:
- Design of clinical studies (phase IIIb and IV) and other evidence-generation programs: rationale, synopsis, protocols, technical documents…
- Involvement of experts and management of Study Steering Committee
- Sub-contracting: support drafting of the specifications & definition of deliverables, follow-up of subcontracted activities
- Analysis and interpretation the results of the study, validation of study reports
- Contribution to internal and external communication of study results (Abstracts, publications, posters…),
- For IIT Program management: review IIT concept, support affiliates in managing IIT concept in execution, prepare the overview of the IIT program
✓ Work in close collaboration:
- with the key medical affairs stakeholders: medical lead, evidence generation lead, medical communication lead and publication manager
- With other departments and be their main contact for the activities you coordinate: R&D, global marketing and market access, affiliates
- With external partners: experts, cooperative groups, investigators, vendors (CROs, agencies…)
✓ Good practices:
- Regarding medico-scientific, operational, legal, regulatory, safety aspects
- In respect of budget, timelines, quality of deliverables
- In compliance with internal procedures (SOP), applicable regulation (GCP, GVP) and compliance rules (Fair Market Value).
Vos points forts
Strong interest for medical & scientific understanding, clinical & medical practice
- Previous experience in clinical studies management is a plus (Phase 3b, Real World Evidence, early access patient programs, IIT Program)
- Oncology therapeutic area knowledge is optional, but willingness to learn and adaptation capability is needed.
- Ability to work globally and cross functionally, and to contribute to multiple projects with strategic, analytical vision and business understanding
- Excellent communication skills in working with cross-functional and multi-cultural teams (oral and written English)
- Positive and committed attitude, solution and results driven, collaborative mindset
Profil recherché
- Medicine or Pharmacy student or life sciences, such as biology, biochemistry, or business school with life science
Notre proposition
- Intégration à une équipe expérimentée et hyper dynamique
- Durée du stage : 12 mois
- Type de contrat : alternance
- Lieu : Suresnes et télétravail
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