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Country Approval Specialist/Contract SpecialistAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies.Discover Impactful Work:Prepares and negotiates contracts, as well as, finalizes the contract process. Liaises and establishes effective relationships with sites and internal functional teams. Ensures quality, objectivity, and risk analysis in the efficient delivery of contracts.A day in the Life:Prepares, reviews, and coordinates local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.Drafts, reviews, negotiates, and finalizes agreements with study sites in accordance with local/accepted process.Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms, and conditions in accordance with company contractual considerations.Ensures compliance to established negotiation parameters, authority approval, contractual process, and client expectations.Identifies and assesses legal, financial, and operational risks and escalates to appropriate level of the organization per established processes.Provides recommendations and alternative resolutions to Investigator Contracts negotiations through established escalation channels.Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines.Achieve target cycle times for site activations.Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate.Education and ExperienceBachelor's degree or equivalent and relevant formal academic/vocational qualification.Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years).In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills, AbilitiesGood understanding of the principles of contract law, including a general understanding of laws that influence contract language.Demonstrated ability to apply basic principles of investigator grant negotiation.General understanding of business and financial principles that relate to service agreements.Effective communication skills (verbal & written) in English and local language.Capable of drafting and negotiating contract provisions and budgetary issues within parameters.Demonstrated ability in attention to detail.Excellent analytical and decision-based thinking skills.Understanding of the pharmaceutical product development process and involvement of CROs.Able to work independently or in a team environment.Good organizational and time management skills.Able to organize competing priorities logically and review outstanding contractual risk and issues.Able to effectively use automated systems and computerized applications.Ability to demonstrate a customer-focused style of communication, problem solving, and collaboration.How to apply: Please submit your CV in English.
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