As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Travel: Yes
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"When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."Chris – Associate Director, Regulatory & Access
"In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"Riley – Regulatory Affairs Consultant
We are one truly global team working together to propel each client´s journey ahead faster.
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
Work with industry leaders and subject matter experts.
The ability to innovate, ask “what if” and try new solutions without fear of failure.
Opportunities to work on multiple accounts – never boring!
Strong management with depth of experience working for global health authorities.
The Principal Consultant, Real-world Evidence EU/UK is an experienced professional with proven study design, consulting, thought leadership and business development skills within the field of Real-world Evidence. This individual must have significant experience in the application of their expert knowledge to the design and successful delivery of real-world data studies which incorporate EMR, healthcare claims, patient registries, and other sources of secondary data for a variety of client-specific goals. The Principal Consultant, RWE EU/UK will support the overall growth of the team and business in the region, providing leadership and management in collaboration with the broader RWE and Access team.
- Ensure development of project plan detailing responsibilities, budgets, and timelines for any given RWE project
- Guide clients on RWE data sets and how best to select the right data sources given the study question at hand
- Lead analytical team including statistical programmers and epidemiologists to conduct variable creation, data manipulation and statistical analyses
- As a project director, oversee the development of study protocol, analysis plans, and study reports as well as data analysis
- Communicate with clients on a regular basis (project updates, results, discussion, present capabilities, discuss new potential projects)
- Active participation in the proposal development process through delivery of scientific data considerations (epi, stats, informatics, etc) for proposals and presentations at bid defenses
- Development of industry network and identification of potential new business opportunities through networking and actively working with global sales team
- Active participation in leading industry and academic forums and regular Thought Leadership contributions (e.g. presentations, articles, posters, etc.)
- Provide analytical advice to peers and clients
- Develop and manage client relationships
- Develop and manage relationships with external data source organization as well as manage data access contracting and applications
- Provide guidance, training, and mentorship to all parts of the business involved in delivery of Real-world Evidence projects and services
- Proactive mentoring of RWE team, including team supporting traditional site-based RWE studies
- Demonstrated expertise in RWE in the EU/UK, including support of proposal development and team building
- Possess extensive knowledge of European secondary real-world data (RWD) sources such as claims, EMR, clinical databases, and other specialized data collection initiatives, ideally with existing relationships with these data holders.
- Experience with end-to-end RWE project delivery focused on secondary data (RWD)
- Recent Pharmaceutical / CRO/Consultancy experience
- Master’s degree or PhD in the area of outcomes research, epidemiology, biostatistics, statistics, health services research, or a related field, or equivalent professional experience
- Highly effective communicator, both written and verbal, at all levels with customers, internally and with the industry at large
- Comfortable operating in a demanding, fast-paced environment and capable of reacting swiftly to changing business demands
- Driven to deliver quality results on time and in a highly ethical and professional manner
- Consistent track record of successfully cultivating and managing client relationships
- Strong client and project management skills on project director level
- A high degree of written accuracy and attention to detail
- Strong communication skills, especially in the relaying of technical information and project concepts
- Fluent English, additional language would be an asset
- Flexible, determined, and self-motivated
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