ppbWork Schedule /b /ppStandard (Mon-Fri) /ppbEnvironmental Conditions /b /ppOffice /ppbJob Description /b /ppJoin Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation /ppWe have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
/ppAs part of our global team, you'll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy.
As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.
/ppWhat You'll Do: /ppbOBJECTIVES/PURPOSE /b /pulliSupporting the facilitation of site start up and communication with internal and external team members to ensure prompt site approval and study timelines are achieved.
/liliSupport sites and study teams to achieve rapid site start up.
/li /ulpbACCOUNTABILITIES /b /pulliWork directly with assigned sites on all site related essential document collection and review.
/liliPartner with internal Study Startup team, CROs, Clinical Operations teams, and partners to improve overall SSU metrics and deliver processes.
/liliEnsure standards are applied to the SSU processes across projects.
/liliReview site essential documents for start up including but not limited to: ICF, FDF, ****, CVs etc /liliPromptly recognize and improve potential site activation delays and escalated to appropriate team members.
/liliTrack all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.




/liliSupport resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
/liliReview and provide feedback to management on site performance metrics.
/liliEnsure accuracy and completeness of the eTMF for assigned sites during start up /li /ulpbDIMENSIONS AND ASPECTS /b /ppbTechnical/Functional (Line) Expertise /b /pulliUnderstanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc.) /liliUnderstanding of Clinical Trial Agreements, budgeting and fair market value principals /liliKnowledge or FDA and ICH-GCP guidelines for conducting clinical research /li /ulpbLeadership /b /pulliDemonstrated ability to work across functions, regions and cultures /liliThe ability to inspire, motivate and drive results /liliExcellent communicator, able to persuasively convey both ideas and data, verbally and in writing /liliProven skills as an effective team player who can engender credibility and confidence within and outside the company /liliAbility to distil complex issues and ideas down to simple comprehensible terms /liliEmbraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization /li /ulpbDecision-making and Autonomy /b /pulliBroad decision-making responsibilities:



/liliAbility to make decisions /liliAccountable for decision making for designated tasks /liliAbility to seek diverse input from multiple constituents and stakeholders to drive innovative solutions /liliAbility to incorporate feedback and ensure decisions are made swiftly to yield flawless execution /li /ulpbInteraction /b /pulliEffectively navigates the changing external and internal environment /liliEffectively represent Takeda in High-level negotiations with the ability to resolve conflict in a constructive manner /liliTakes the initiative and proactively resolves challenges with internal and external team members.
/li /ulpbComplexity /b /pulliAbility to work in a global ecosystem (internal and external) with a high degree of complexity /li /ulpbEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: /b /pulliBS degree or international equivalent /lili2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.
/liliAbility to explain data to facilitate decision making processes to be data driven.
/liliKnowledge and understanding of clinical study protocols and essential documents /liliStrong organizational skills, decision making, communication and negotiation skills /liliProficient in Microsoft Excel, Word, and PowerPoint.
/li /ulpThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
/p /p #J-*****-Ljbffr

📌 Country Approval Specialist - Fsp - Italy (Milano)
🏢 Thermofisher Scientific
📍 Milano