Country Approval Specialist/Submissions Specialist

at  Thermo Fisher Scientific

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.
Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

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 2-5 years).
• 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, ABILITIES

• Good understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws
• Demonstrated ability to apply basic principles of investigator grant negotiation
• General understanding of business and financial principles that related to service agreements
• Effective communication skills (verbal & written) in English and local language
• Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters
• Demonstrated ability in attention to detail
• Excellent analytical and decision based thinking skills
• Understanding of the pharmaceutical product development process and involvement of CROs
• Able to work independently or in a team environment
• Good organizational and time management skills
• Working knowledge of PPD SOP & WPDs
• Able to organize competing priorities logically and review outstanding contractual risk and issues
• Able to effectively use automated systems and computerized applications
• Ability to demonstrate a customer focused style of communication, problem solving and collaboration

Please refer the Job description for details