Thermo Fisher’s clinical research business mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in between, it’s you! We know that meaningful results require not only the right approach but also the right people. We invite you to re-imagine health-promoting protocols with us, working alongside our talented, bright, and energetic teams.
Our goal-driven teams combine and deliver start-up activities for clinical trials, collaborating to improve processes, cycles,s and flexibility. We partner with our sites, businesses, and colleagues around the world to decrease start-up timelines and exceed expectations.
Job Title: Country Approval Specialist
PPD, now part of Thermo Fisher Scientific is currently looking for a Country Approval Specialist to join our team in Ghana./ /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 SIA services and coordinate of these projects
- May have contact with investigators for submission-related activities
- Key contact at the 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 the submission process for sites and study are aligned to the critical path for site activation
- May work with the start-up 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 SIA activities onto PPD 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 PPD, part of Thermo Fisher Scientifics WPDs or applicable client SOPs
- Maintain knowledge of and understand internal SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
To be considered for the role of Country Approval Specialist you should have:
- Bachelor’s degree
- 2 years related experience or equivalent combination of education, training, & experience
- Effective oral 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
- Excellent English language skills
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently, under direction, as required
- Basic organizational and planning skills
- Basic knowledge of all applicable regional/national country regulatory guidelines and EC regulation
At PPD, now part of Thermo Fisher Scientific we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career. Therefore at PPD you will benefit from an award-winning learning and development program, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based on the health and well-being of our employees. We have a flexible working culture, where PPD, now part of Thermo Fisher Scientific truly values a work-life balance. We’ve grown sustainably year after year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.