ThermoFisher Scientific Senior / Project Coordinator - Data Analysis and Compliance, client dedicated in Ware, United Kingdom
Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office
Job Description:
Sr Project Co-ordinator (Data Analytics and Compliance) – client dedicated, Ware
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.
The PPD FSP Solution:
PPD's Functional Service Provider division partners with and serves as an extension of our PPD team, supporting our customers' key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality.
This role would be based at our client site in Ware.
Responsibilities:
1. Day-to-Day Document/Data Migration: Provide hands-on support including tracking, migrating, and verifying data and documents between various repositories (internal and/or external).
2. Identify and map data across documentation and regulatory submissions.
3. Manage documentation at various stages of the lifecycle.
4. Process Analytics and Trending: Proactive user of Power BI preferred.
5. Identify key analytic themes/parameters and generate trending information to understand baseline framework, level of control, and improvement.
6. Ensure effective problem analysis and timely resolution of diverse issues, escalating when necessary.
7. Lead the identification and implementation of strategies to improve process, system, and result qualities and efficiencies.
8. Maintain a strong understanding of compliance systems, current technologies, and professional concepts.
9. Schedule and plan work to meet priorities, setting specific daily and weekly priorities to meet timelines.
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+ years).
Knowledge, Skills and Abilities:
1. Familiarity with CMC regulatory filing structures and supporting documentation required for submissions.
2. Flexibility and adaptation to changing environments.
3. Strong verbal and written communication skills.
4. Experience with controlled document computer systems e.g., Veeva.
5. Ability to communicate, influence and negotiate at various levels.
6. Broad knowledge of the R&D Drug Development Process preferred.
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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