Prin Reg Affairs Assistant

Work Schedule

Environmental Conditions

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 Regulatory Affairs global team within PPD® clinical research services deliver regulatory science services, providing regulatory knowledge which accelerates innovation and improves regulatory decision making – and helps our customers deliver life-changing therapies to patients faster.

Provides advanced administrative, contractual and financial support to the department, and supports reporting of such to upper management.

• Coordinates timely collection and management of data, metrics, experience statements for proposal and budget development in response to Request for Proposals (RFPs).
• Supports preparation of bids and proposals; generates, tracks and analyzes data for proposal, revisions, contract modifications and bid defenses.
• Supports department management in reporting financial, contractual and budget data.
• Provides project specific services, documentation and coordination of projects and supports reporting of same to management, internal and external clients.
• Serves as a team lead, which includes providing training to and reviewing the work of junior team members.

• 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 6 years). 3+ years experience in bid preparation and/or the development and fulfillment of contracts and RFP requirements is preferred.

• Excellent organizational and planning skills to effectively manage shifting priorities
• Strong understanding of contractual and proposal documents
• Capable of working effectively on a team and/or independently with minimal supervision
• Excellent electronic document production skills
• Excellent proficiency in several computer applications including Microsoft Office software
• Exceptional attention to detail and quality of documentation
• Outstanding interpersonal skills with the ability to interact with customers
• Excellent verbal and written communication skills
• Capable of multitasking and working under pressure
• First-rate analytical, business and math skills