- Demonstrate the ability to prioritize work and define steps needed to achieve project outcomes.
- Liaise closely with more senior colleagues to discuss issues and resolve conflicts.
- Provide suggestions for improving project efficiencies and results to the project technical lead.
- Seek out information from previous projects, other client work, or colleagues to complete assigned project activities.
- Produce quality work that meets the expectations of the project Team Lead and the client.
- Serve as a Regulatory Lead for small scale projects or work streams.
- Ensure accurate project reporting is in place as the main client contact.
- Ensure project team compliance and adherence to project scope and objectives.
- Identify new opportunities through Change In Scope or add-on businesses from existing work.
- Ensure timely project close-out activities are completed.
- Follow and implement the organization's consulting models and methodologies.
- Provide technical and/or business consulting services within your personal area of expertise. Requirements:
- Previous experience working in industry in support of Global Labeling, Regulatory (Clinical/Safety), or Medical Writing for labeling updates.
- Understanding of the Regulatory processes required to update labeling of a product.
- Familiarity with the Company Core Datasheet (CCDS), and its implementation into labeling and artworks.
- Understanding of Safety Signal Management and the impact of confirmed safety signals on labeling.
- Understanding of Periodic Safety Update Reports (PSUR) and potential impact on labeling.
- Knowledge of the relationship between labeling and artwork processes.
- Familiarity with the Addendum to Clinical Overview (Module 2.5) and its preparation to support a labeling variation.
- Knowledge of Regulatory requirements for labeling updates in different regions (EU, US, and APAC).
- Understanding of EU readability and PIL (Patient Information Leaflet) testing. Skills and Qualifications:
- University degree in a scientific field
- Strong organizational and time management skills.
- Excellent communication and oral skills, with the ability to work efficiently as part of a team.
- Strong interpersonal skills.
- Proactive and efficient work ethic. #LI-REMOTE
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Regulatory Affairs Professional - REMOTE, United Kingdom - Parexel
Description
Parexel is seeking highly motivated and experienced individuals for the position a Senior Regulatory Affairs Associate. This role can be home, or office based in various locations in Europe. As part of our team, you will have the opportunity to work within a collaborative environment and deliver services within your technical expertise. Join us and make a difference in clinical research
Main Role Responsibilities:
