In France, our sponsor dedicated
team continues its expansion, and we have a new opportunity for a Senior Start-up Specialist
THE Senior START UP SPECIALIST JOB
- You will work sponsor dedicated for a prestigious Top 5 global Pharmaceutical company.
- This job is located in Paris , and we are prepared to offer a combination of home & office based work.
The job is perfect to gain a combined and rich experience within the CRO and Sponsor environments. It would suit existing:
WHAT MAKES THESE JOBS SPECIA
- CRO-based Senior Start-up Specialists or Local Start Up Project Managers looking for a closer partnership with a Sponsor, or
- Biopharmaceutical based Start-up Managers looking to have experience within a Global CRO.
- You will join a successful and stable project team: last year we almost doubled our team in France.
- If you come from a CRO environment, you´ll value being exposed to a rich interaction with internal client partners such as Finance, Med Affairs, Quality, Legal and Regional Operations, Head Quarter functional areas...
- This is a pure customer-facing role, allowing you to build high-level business relationships, representing the sponsor to IRB/IECs and Regulatory Authorities, vendors and external partners to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones
- We have a well-organized structure, robust processes in place and unambiguous communication (you will know who to ask, will receive clear answers which will allow you to act fast)
- University/college degree (life science, Pharmacy preferred)
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
- Thorough understanding of the drug development process
- Fluent in French and in English, both written and verbal
You will have significant impact on how France deliver its country-specific trial commitments during study start-up, this is why we need you to bring a minimum of 5 years' experience at a CRO or Bio-pharmaceutical company in start-up
The position requires significant expertise in budget and contract negotiations, the local ethics, legislation and regulatory environment, submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables.
Ability to indirectly influence investigators, vendors, external partners and country managers to deliver these commitments is a must
French and English