When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
REGISTER YOUR INTEREST FOR AN UPCOMING OPPORTUNITY
Parexel FSP is starting to recruit in advance of an upcoming need for an experienced Medical Legal Regulatory/MLR Administrator/Coordinator/Facilitator to join one of our key sponsors.
In this role you will be responsible for reviewing content, metadata and submission quality, ensuring readiness for approval. You’ll be acting as a system superuser (FUSE) whilst supporting system governance and access issues.
This role would suit someone with prior MLR administration or review experience or someone from a medical communication background.
Some specifics about this advertised role
- Responsible for identifying system issues and Global enhancements through testing and QA of Global/International workflows. Contact for cross-collaboration work with FUSE enterprise team in super user calls and supporting Global/International FUSE Market Lead. System access gives expanded capabilities and permissions to go behind the scenes and troubleshoot/problem solve various issues that arise.
- Approve/Reject UAM App access requests. Ensuring training criteria has been met and correct role profile is selected. Continuous maintenance of agency profiles, updating and approving any brand/TA access needed for the FUSE.
- Review dormant accounts, send communications and revoke access.
- Run reports of in-process assets that have been left opened and never finished.
- Track and fill out deviation report, if SOP and process are not followed
Who are Parexel
Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.
We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.
You’ll be an influential member of the wider team.
What we are looking for in this role
For every role, we look for professionals who have the determination and courage always to put patient well-being first.
That to us is working with heart.
Here are a few requirements specific to this advertised role.
- 1-2 years’ experience in pharmaceutical/biotech or advertising industry and/or digital marketing operations role
- Functional experience in regulatory, medical, marketing operations, sales or communications preferred
- Working knowledge of compliance guidelines on advertising and promotion
- Basic understanding of process optimization and asset creation
- Proficiency in computer applications, including Microsoft Office, Adobe Acrobat
- Working knowledge of clinical trial functions, including clinical operations, regulatory and drug safety.
- Ability to prioritize and manage multiple tasks simultaneously.
Top Skills
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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