Clinical Contract Specialist

hace 4 semanas


Insurgentes, México Novartis A tiempo completo

**Summary**:The Contracts Specialist provides contracting life cycle management support and business solutions optimizing operational expertise to Medical Affairs, partnering with all areas in the end-to-end planning process and execution.**About the Role**:**Key Responsibilities**:- Contract Life Cyle (CLC) Management: Performs contract management processes for execution/implementation of MA business contracts in accordance with business needs. Records tracking metrics in accordance with required data points.- Contract: Executes contractual documents within primary areas such as Research Collaboration support, Letters of Agreements, Letters of Intent, Licensing Agreement support. Assists CBS Team in populating complex templates (such as research agreements, term sheets, Licensing agreements, etc.) Secondary areas: HCP engagement agreements (Authorship; Preceptorship, Speakers, Consultancy); Site Agreements; Amendments; confidentiality agreements; Letters of Indemnification etc. Provides follow up to ensures contracting activities, with quick and efficient turnaround times, in adhere to Internal SOP and WP processes, and Corporate Integrity. Produces final contracts/amendments and secures all necessary company approvals to facilitate execution of said agreements. Ensures appropriate contractual Amendments and Addendums are in place. Assists MA CBS team in preparing project specific metrics and milestones for both original contracts and amendments.- Collaborator: ability to communicate effectively with Legal and Patent departments and to answer questions regarding contract terms, scopes of work, pricing, and payment schedules within the framework of the US legal and compliance requirements. Aids Contracts Ops Mgr. and/or NOCC Lead to ensure timely execution and efficient negotiations/management. Records metrics timing for capturing and reporting of data related to his/her operational performance.- Budget management: Ensures FMV and Schedule As abide by Laws, Regulations and adhere to all local process, aligning milestone deliverables with cost and payment to ensure mínimal deviations from local guidelines and standards.- Knowledge management: laws and regulations associated with contract language regarding Phama, regulations to GxP, with specific knowledge of Phase 1-IV, Registries, HCP Engagements, and IIT studies with secondary knowledge including, but not limited to, research collaborations, HCP engagements, Letters of Agreement/Indemnification, and confidentiality agreements, that may shift based on evolving business needs.**Essential Requirements**:- Advanced English, level C1 - C2- Bachelor’s degree in business/legal field required.- Knowledge and understanding of clinical trial conduct and regulation to support the US Organization.- Full knowledge of research operations scopes, inclusive of different types of research projects, such as HEOR/RWE, NIS/registries, IITs, and sponsored trials.- Demonstrate knowledge and understanding of Inventions and Patents, Indemnification regulatory, and privacy regulations in the US Market.- Demonstrate successful negotiation for FMV budgets, contracts, reconciliation, and amendments: HEOR, vendor, research sites, IIT, NIS, HCP and CDA with mínimal oversight.- Proficient Understanding of fair market value, benchmarking costs and budgets.- Possess internal and/or external influence to achieve business & operational objectives.- Excellent interpersonal skills (team player).- Proven negotiation skills.- Must be able to work independently and be fully agile in adapting to evolving business needs- Proven record of accomplishments that demonstrate solution mindset and multitasking skills.- Demonstrated track record of success in a contract function working with multidisciplinary drug development teams in different phases of development- Strong written, oral & presentation skills, with an ability to make professional and credible first impressions.- Possess organizational and analytical skills.- Ability to work on multi-faceted projects.- Excellent interpersonal communication and cross-functional collaboration skills.**Commitment to Inclusion**Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.DivisionOperationsBusiness UnitUniversal Hierarchy NodeLocationMexicoSiteINSURGENTESCompany / Legal EntityMX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.Functional AreaResearch & DevelopmentJob TypeFull timeEmployment TypeRegularShift WorkNo**Accessibility and accommodation**:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.



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