Country Approval Specialist (Submission specialist) - Belgium > Thermo Fisher Scientific > Joboolo BE :
Société : Thermo Fisher Scientific Lieu : Brussels Brussels Site source : Talent BE
With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.Our Clinical Operations team in Belgium is expanding and we are currently looking for a CountryApprovalSpecialist who will be working from our office or home based anywhere in Belgium.As a CountryApprovalSpecialist, you will:
Prepare, review and coordinate, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategyProvide, under guidance local regulatory strategy advice (MoH &/or EC) to internal clientsProvide project specific local start up services and coordination of these projectsMay have contact with investigators for submission related activitiesKey-contact at country level for either Ethical or Regulatory submission-related activitiesCoordinate, under guidance, with internal functional departments to ensure various site start up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activationMay work with CRA(s) to prepare the regulatory compliance review packages, as applicableMay develop country specific Patient Information Sheet/Informed Consent form documentsMay assist with grant budgets(s) and payment schedules negotiations with sites.Support the coordination of feasibility activities, as required, in accordance with agreed timelinesEnter and maintain trial status information relating to start up activities onto PPD clinical research services tracking databases in an accurate and timely mannerEnsure the local country study files and filing processes are prepared, set up and maintained as per internal WPDs or applicable client SOPsMaintain knowledge of and understand company SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services providedKeys to Success:
Bachelor's degreeProven elated experience or equivalent combination of education, training, & experienceEffective oral and written communication skillsExcellent interpersonal skillsStrong attention to detail and quality of documentationGood negotiation skillsGood computer skills and the ability to learn appropriate softwareFluency in English and either Dutch or FrenchBasic medical/therapeutic area and medical terminology knowledgeAbility to work in a team environment or independently, under direction, as requiredBasic organizational and planning skillsBasic knowledge of all applicable regional / national country regulatory guidelines and EC regulation At PPD clinical research services we hire the best, develop ourselves and each other, and recognise the power of being one team.
We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees.
We have a flexible working culture, where PPD clinical research services truly value a work-life balance.
We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.
We are a global organisation but with a local feel.Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Watch as our colleagues explain 5 reasons to work with us.
As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
#StartYourStory with PPD, part of ThermoFisherScientific, where diverse experiences, backgrounds and perspectives are valued. ThermoFisherScientific BrusselsBrussels
