• Job Description

  Req#: TFSCGLOBALR01206481EXTERNALENGLOBAL

  Job Description

  Country Approval Specialist (Submissions Specialist) - UK - Remote

  At 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. 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 the UK are currently hiring for a Country Approval Specialist who will be working from our office in Cambridge or Bellshill, or home based anywhere in the UK.

  As a Country Approval Specialist, you will:

  • Prepare, review and coordinate, under guidance, 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

  • Provide, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients

  • Provide project specific local start up services and coordination of these projects

  • May have contact with investigators for submission related activities

  • Key-contact at country level for either Ethical or Regulatory submission-related activities

  • Coordinate, 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 activation

  • May work with CRA(s) to prepare the regulatory compliance review packages, as applicable

  • May develop country specific Patient Information Sheet/Informed Consent form documents

  • May assist with grant budgets(s) and payment schedules negotiations with sites.

  • Support the coordination of feasibility activities, as required, in accordance with agreed timelines

  • Enter and maintain trial status information relating to start up activities onto PPD clinical research services tracking databases in an accurate and timely manner

  • Ensure the local country study files and filing processes are prepared, set up and maintained as per internal WPDs or applicable client SOPs

  • Maintain knowledge of and understand company SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

  Keys to Success:

  • Education and Experience:

  • Bachelor'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 1+ years)

  • Background in regulatory activities, submissions and other responsibilities as part of the start-up CRO activities would be considered an advantage
    

  • Knowledge, Skills, and Abilities:

  • Effective verbal and written communication skills

  • Excellent interpersonal skills

  • Strong attention to detail and quality of documentation

  • Good negotiation skills

  • Good computer skills and the ability to learn appropriate software

  • Fluent English language and grammar skills

  • Basic medical/therapeutic area and medical terminology knowledge

  • Ability to work in a team environment or independently

  • Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

  • Full right to work in the UK is essential.

  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 Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

  Apply today! http://jobs.thermofisher.com

  Thermo 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.

• About the company

  Thermo Fisher Scientific is an American provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.

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