Responsable Scientifique Principal – Rédaction réglementaire Sécurité et Efficacité
- Writing types
- Regulatory, Scientific communications
- Seniority
- Senior
About the role
Responsibilities
- Define and propose the development plan for Efficacy and Safety sections
- Write regulatory sections documenting efficacy and safety in compliance with applicable regulations
- Lead the response strategy to authority questions on submitted efficacy and safety sections
- Represent the PCC department within project teams and coordinate development actions
- Contribute to scientific communication, literature monitoring and the Group's external image
Requirements
- Bac + 6 or scientific doctorate with specialty, or equivalent
- 10 years of experience in drug development
- Proficiency in dedicated IT tools
- English C1
- Openness, analytical and synthesis skills, proactive proposals
Benefits
- Fixed salary by profile, 10% variable bonus on objectives, company vehicle
- Enhanced holiday bonus, profit sharing, company savings plan
- Health and provident insurance, meal vouchers, 13 RTT days
- Works council and well-being events
About the Company
- Independent veterinary pharmaceutical group for over 90 years, with more than 2500 employees across 24 countries.
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