
Advanced Pharmaceutical Agreement Specialist
Há 2 dias
Job Description:
To drive clinical development, our team is seeking a seasoned professional with expertise in negotiating and drafting clinical trial agreements. This role requires a strong understanding of pharmaceutical industry regulations and contract law.
As Senior Clinical Contract Specialist, you will be responsible for developing and analyzing contractual relationships, including investigator grants, to ensure fair market value aligned with regional knowledge and J&J grant pricing guidelines.
Key Responsibilities include:
- Preparing, negotiating, and finalizing clinical trial agreements and ancillary agreements for company-sponsored and/or investigator-initiated studies.
- Analyzing contract requests/needs from operating companies and translating into appropriate contracts/budgets for company-sponsored and investigator-initiated clinical trial agreements.
- Providing specialized support for negotiations in confidentiality agreements, informed consent forms, and other ancillary contract documents as required.
- Working with the global CCS team to review and analyze contractual terms and conditions to reach acceptable language.
- Liaising with CCS management and functional CCS support teams, legal, Healthcare Compliance, Risk Management, Privacy, and other stakeholders to obtain guidance and escalate issues as appropriate.
- Proactively improving processes and establishing refinements that reduce cycle time, create savings, and improve efficiency in the initiation of clinical trial sites.
Required Skills and Qualifications:
- Bachelor's degree in an appropriate scientific or business discipline.
- 3-5 years of experience and/or equivalent competencies in the pharmaceutical industry/clinical research.
- Familiarity with healthcare compliance and other relevant guidance is a plus.
- A working knowledge of the clinical development process with 2 years of negotiation and contract experience.
- Familiarity with clinical research processes.
- Ability to work effectively in cross-functional teams.
- Strong and proven negotiation and problem-resolution skills.
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