About Thermo Fisher Scientific

At Thermo Fisher Scientific, you have the chance to contribute to groundbreaking research that positively impacts the world. Our mission is to enable our customers to make the world healthier, cleaner, and safer. We support our teams with the essential resources to reach their career goals while advancing science through research, development, and delivery of transformative therapies. Join us in a role that drives meaningful change and improves health outcomes globally!

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Responsibilities

• Prepare, review, and coordinate local regulatory submissions under mentorship to align with global submission strategies
• Provide local regulatory strategy advice (MoH &/or EC) to internal clients
• Offer project-specific local SIA services and coordination
• Serve as a key contact at the country level for Ethical or Regulatory submission activities
• Coordinate with internal departments to ensure site start-up activities align with submission timelines
• Achieve PPD's target cycle times for site activation
• Assist start-up CRAs in preparing regulatory compliance review packages
• Develop country-specific Patient Information Sheet/Informed Consent form documents
• Support grant budget and payment schedule negotiations with sites
• Coordinate feasibility activities in accordance with agreed timelines
• Enter and maintain trial status information on PPD tracking databases accurately and timely
• Ensure local country study files are prepared, set up, and maintained per PPD WPDs or applicable client SOPs
• Maintain knowledge of PPD SOPs, Client SOPs/directives, and current regulatory guidelines

Requirements

• Proven experience in regulatory submission processes
• Outstanding organizational and coordination skills
• Ability to work collaboratively in an ambitious and innovative environment
• Strong communication skills to interact with investigators and internal clients
• Strict attention to detail and determination to deliver flawless results

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Comprehensive healthcare
• Range of employee benefits
• Career and development prospects in an innovative, forward-thinking organization
• Company culture focused on integrity, intensity, involvement, and innovation

Equal Opportunity

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.