January 31st, 2023 at 08:13 am
Thermo Fisher Scientific Latest Job Opportunity
ROLE: Senior/Principal Regulatory Affairs Specialist – CTA (Clinical Research Field)
At Thermo Fisher Scientific, you’ll find work that matters and has a positive effect on people all over the world. Join our other employees in making our Mission a reality, which is to help our customers make the world a healthier, cleaner, and safer place. We give our teams the tools they need to reach their own career goals while pushing science forward through research, development, and the delivery of therapies that can save lives.
Clinical trials are done in more than 100 countries, and our PPD clinical research portfolio is always making new frameworks for clinical research. Our work includes lab, digital, and decentralized clinical trial services. Your commitment to quality and accuracy will improve health outcomes that people and communities depend on now and in the future.
Job Description:
We are looking for a Senior/Principal Regulatory Affairs Specialist to join our growing Regulatory Science team in the Regulatory Affairs department. This is a great chance to move up in your regulatory career and learn more about this field.
Responsibilities
- In this role, you will be a key member of the team and should have experience with regulations.
- You will provide innovative solutions, such as global regulatory therapeutic area expertise and client interface, to provide strategic regulatory intelligence, guidance, and regulatory expertise for product development from preclinical through registration and product optimization.
- You will feel comfortable giving regulatory advice and working on projects related to regulatory affairs services.
- You will also be able to act as a liaison with internal and external clients to provide and market these services.
- You’ll work with the Regulatory Affairs management to do the day-to-day work of the department, such as preparing and putting together global regulatory submissions without help, talking to sponsors, reviewing and evaluating clinical trial regulatory documents, and reviewing and evaluating scientific literature.
- You will also be the main person sponsors can talk to about their projects.
Requirement
To do well in this job, you need to have the following skills:
- Experience making rules and regulations around the world
- Bid defense meeting experience and knowledge
- Experience leading regulatory projects around the world
- Client facing experience
Education and Experience:
- Bachelor’s degree or advanced degree preferred, or equivalent and relevant formal academic/vocational qualification
- Previous experience that gives the necessary skills, knowledge, and abilities to do the job
- Knowing how clinical trials are run around the world
- Proven experience managing projects and performing well in a client-facing role.
- Knowledge, skills, and abilities: Excellent command of written and spoken English, as well as the local language when needed. Excellent attention to detail and quality, as well as excellent editing and proofreading skills.
- Excellent people skills to work well in a team setting and serve as a link between other departments.
- Advanced computer skills, including using Microsoft Word, Excel, and Power Point; able to learn new technologies
- Strong organizational, time management, and planning skills to make and stick to schedules, do long-term planning, adjust to changing priorities, and handle multiple projects.
- Excellent negotiation skills
- Capable of working alone and using their own judgment to figure out what the sponsor’s regulatory needs are and work with the rest of the project team to make sure the deliverables meet those needs.
- Excellent understanding of global, regional, and national country requirements and regulatory procedures for clinical trial approval; expert knowledge of ICH and other global regulatory guidelines
- Excellent skills in analyzing, investigating, and solving problems
- Learn how to make budgets and forecasts
What we do:
At PPD Clinical Research Services, we hire the best people, work to improve ourselves and each other, and know how important it is to work as a team. We know that you will want to grow both professionally and personally over the course of your career. At PPD, you will have access to a learning and development program that has won awards and will help you reach your full potential.
We offer our employees a competitive salary and a wide range of benefits that focus on their health and well-being. We have a flexible work culture, and PPD Clinical Research Services really cares about having a good balance between work and life. We’ve grown steadily from year to year, but we still have teams of coworkers who are eager to share their knowledge and have fun together. We are a worldwide organization, but we feel like a small town.
How to Apply for this Thermo Fisher Scientific Latest Job Opportunity
Deadline: February 7, 2023
Also, For more Job Opportunities CLICK HERE
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