SSU

Job description

Work Schedule Environmental Conditions

Job Description

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!

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

We offer competitive remuneration, an annual incentive plan bonus, comprehensive healthcare, and a range of employee benefits. Working with Thermo Fisher Scientific means joining an innovative, forward-thinking organization with outstanding career and development prospects. Our exciting company culture stands for integrity, intensity, involvement, and innovation. Join us and be part of a team that values diverse experiences and perspectives!

Responsibilities

internal clients, regulatory compliance, regulatory guidelines, environmental, regulatory submission, mentorship, regulatory strategy, submission timelines, Director of Project Delivery, Head of Support, QA Head, Director of Project Office, Business Unit Director, Director of Project Management, Clinical Project Manager, Operations Director & Managing Director, Director & Project Manager, Country Head