Essential Functions
- Prepare Project Agreements (Project Agreements include but are not limited to Master Service Agreements, Letters of Intent, Statements of Work, Project Specific Agreements, Confidentiality Agreements, Subcontractor Agreement, Clinical Trial Agreements (Multi and External Site Studies) Preferred Provider Agreements, and other agreements requested by management, whether or not directly related to or in support of any project).
- Review Data Prtoectio Agreements (DPAs) and other privacy-related agreements
- Independently review and negotiate all project agreement terms and conditions
- Serve as point of contact to facilitate legal review.
- Track and report contract review status and provide weekly updates
- Work closely with Finance, Operations, Business Development and key stakeholders regarding Project Agreement execution and details.
- Independently coordinate Subcontractor Agreements such that the terms and conditions are in compliance with the associated Sponsor Agreements.
- Develop and negotiate Change Orders to Project Agreements.
- Perform cash flow analysis and generate payment schedules in coordination with Finance and contract management guidelines.
- Participate and lead meetings with Sponsors, Subcontractors, Finance, Operations, Business Development and key stakeholders.
- Develop a knowledge of Biopharma market segments and assess business risk associated with contractual terms and provide guidance to management.
- Ability to complete a high volume of Project Agreements in a timely and professional manner, working efficiently and maintaining quality.
Requirements
- Bachelor’s degree required. Degree emphasis in business or life science discipline preferred.
- Minimum of 5+ years in the Pharmaceutical or CRO industry experience preferred
- Minimum of 5+ years contract drafting and negotiation experience
- Problem solving and negotiation skills required
- Proficient in Microsoft Excel and Word
- Excellent customer service skills and attention to detail
- Must be able to work independently
- Experience and comfort in a high volume, fast paced environment is essential.
- Ability to interact with multiple stakeholders, both internal and external.
- Excellent attention to detail, ability to multi-task, and be flexible to address needs of multiple market segments and various lines of service.
- Prior experience and familiarity with fee generation, payment schedules, contracts and client interaction and negotiation preferred.
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Skills Required
- Bachelor's degree
- At least 5 years of contract drafting and negotiation experience
- Problem-solving and negotiation skills
- Proficiency in Microsoft Excel and Microsoft Word
- Excellent customer service skills and attention to detail
- Ability to work independently
- Ability to work efficiently in a high-volume, fast-paced environment
- Ability to interact with multiple internal and external stakeholders
- Ability to multitask and adapt to multiple market segments and service lines
- At least 5 years of pharmaceutical or CRO industry experience
- Business or life science degree emphasis
- Experience with fee generation, payment schedules, contracts, client interaction, and negotiation
What We Do
Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines. With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. Our operations are strategically located in: Lincoln, Nebraska (Corporate Headquarters) Philadelphia, Pennsylvania Phoenix, Arizona Belfast, Northern Ireland,UK Zurich, Switzerland Vienna, Austria Richmond, Virginia Montreal, Quebec, Canada For more information, visit: www.celerion.com
