FSP Country Approval Specialist

h3Work Schedule /h3 pStandard (Mon-Fri) /p h3Environmental Conditions /h3 pOffice /p h3Job Description /h3 pJoin us as a Country Approval Specialist and make an impact at the forefront of innovation. We 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. As 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. /p h3What you will do: /h3 ul lipPrepare, review and coordinate 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 EU/global submission strategy /p /li lipProvide local regulatory strategy advice (MoH /or EC) to internal clients /p /li lipProvide project specific local start-up services and coordination of these projects /p /li lipMay have contact with investigators for submission related activities /p /li lipServe as key-contact at country level for either Ethical or Regulatory submission-related activities /p /li lipCoordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation /p /li lipAchieve target cycle times for site activation /p /li lipPrepare the regulatory compliance review packages, if applicable /p /li lipDevelop country specific Patient Information Sheet/Informed Consent form documents /p /li lipMay assist with grant budget(s) and payment schedules negotiations with sites /p /li lipMay support the feasibility activities, as required, in accordance with agreed timelines /p /li lipEnter and maintain trial status information relating to start-up activities onto the study specific tracking databases in an accurate and timely manner /p /li lipEnsure the local country study files and filing processes are prepared, set up and maintained as per applicable SOPs /p /li lipMaintain knowledge of and understand SOPs, client directives, and current regulatory guidelines as applicable to services provided /p /li /ul h3Education and experience: /h3 ul lipBachelor's degree or equivalent and relevant formal academic/vocational qualification /p /li lipPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) /p /li lipIn 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 /p /li /ul h3Knowledge, skills and abilities: /h3 ul lipEffective oral and written communication skills /p /li lipExcellent interpersonal skills /p /li lipStrong attention to detail and quality of documentation /p /li lipGood negotiation skills /p /li lipGood computer skills and the ability to learn appropriate software /p /li lipGood English language and grammar skills /p /li lipBasic medical/therapeutic area and medical terminology knowledge /p /li lipAbility to work in a team environment or independently, under direction, as required /p /li lipBasic organizational and planning skills /p /li lipBasic knowledge of all applicable regional/national country regulatory guidelines and EC regulations /p /li /ul h3Working conditions and environment: /h3 ul lipWork is performed in an office environment /p /li lipExposure to electrical office equipment /p /li /ul pThermo 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 #J-18808-Ljbffr