Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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.
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Our Regulatory Affairs Department is looking for a Regulatory Affairs Assistant to become a part of the Bulgarian FLEX team.
Reg Affairs Assistant - FLEX
Major Responsibilities:
- Provide project specific services, documentation and coordination of projects and supports reporting of same to management, internal and external clients.
- Work on difficult or complex assignments requiring considerable judgment and initiative to resolve issues. Understand implications of work and make recommendations for solutions and /or new procedures.
- Complete tasks in resourceful and / or creative ways and may contribute to the development of concepts and techniques.
- May act independently on determining methods and procedures on new assignments. May be a facilitator (formal or informal).
- Contact with individuals representing outside organizations, and / or individuals of significant importance within the company. Contacts involve planning and preparation of communications.
- Work as support to Regulatory lead: uploading of documents, File review, work with different system (PPD's and sponsor's)
Education and Experience:
- High school / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years). Prior experience in the pharmaceutical/CRO industry is preferred
In 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.
Knowledge, Skills and Abilities:
- Good organizational and planning skills to effectively manage shifting priorities
- Capable of working effectively on a team and/or independently with minimal supervision
- Good electronic document production skills Good proficiency in several computer applications including Microsoft Office software
- Good attention to detail and quality of documentation
- Good interpersonal skills with the ability to interact with customers
- Solid verbal and written communication skills
- Capable of multitasking and managing multiple projects
What we offer:
At PPD clinical research services 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, 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 organization 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.
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.
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