Specialist, Regulatory

7 days ago


United Kingdom NEC Software Solutions Full time

We are seeking a talented individual to join our team as a Real-World Evidence Specialist, to play a critical role in defining and implementing go-to-market strategies for data-driven RWE products and services in UK & ROW healthcare markets.

Drive the long-term RWE data strategy by developing a deep understanding of customer demand, competitor offerings and market trends, and translate that intelligence into requirements for service enhancements and/or new developments.
Stay current with the latest advancements in real-world evidence methodologies and regulatory requirements.

Engage with external stakeholders, such as key opinion leaders, healthcare providers, industry and regulatory agencies, to enhance the understanding of real-world evidence and to promote NEC.
Develop partnerships with Medical Societies, Academic Institutes, Healthcare Providers, healthcare technology and system suppliers other data owners to build meaningful collaborations.
Support launch activities to ensure that Sales, Pre-Sales, Consultancy and Project Management teams understand our proposition, messaging and go-to-market strategy.
Regulatory & Compliance Support
~ Ensure our products and services comply with relevant regulatory, scientific and ethical standards in the conduct of RWE studies.

Knowledge Sharing & Training
~ Provide training and mentorship to team members and stakeholders on RWE concepts and best practices.


This position involves leveraging diverse real-world data (RWD) sources to generate insights that support research, regulatory, and market access strategies. The ideal candidate will have a strong background in, RWE, epidemiology, biostatistics, or related fields along with experience working in biopharmaceutical, MedTech, academia, healthcare provider or relevant consultancy companies. A deep understanding and experience of RWD/RWE and/or related disciplines to generate scientifically rigorous evidence in support of regulatory requirements.
Strong cross-functional experience working with Clinical, Commercial and Regulatory colleagues.
Understanding of and experience with research methodology and statistical methods related to clinical data analysis.

Master’s or PhD in Epidemiology, Biostatistics, Outcomes Research or a related field.

Minimum of 3-5 years of experience in real-world evidence, epidemiology, health economics, outcomes research, or a related field.
Proven track record of designing and executing real-world evidence studies in a pharmaceutical, biotech, MedTech or healthcare environment.
Experience working with healthcare data sources such as electronic health records or registries.

Familiarity of statistical software (e.g., SAS, R, STATA) and data management tools.
Knowledge of regulatory requirements and guidelines related to RWE.

Creative and overall strong problem solver who is a go-to subject matter expert.
Continuously seeking to enhancing standards through expansion of knowledge and training.
We pride ourselves in offering an excellent benefits package, including an above average pension scheme. When you join the team at NEC Software Solutions, you are provided with the following:

~ Private Medical Cover funded by NEC for Employees (with the option to add family members at an additional cost)
~25 days paid holiday with the option to buy/sell (FTE)
~4 x basic salary life assurance cover funded by NEC (with the option to increase cover at an additional cost)
~ A Group Pension Plan with fantastic employer contributions up to a maximum of 8.A selection of flexible benefits to suit your individual needs
~ Candidates must be able to demonstrate a pre-existing right to work and travel within the UK. Depending on the nature of the role a Disclosure Barring Service (DBS) check may also be required along with further vetting checks like SC and NPPV3

NEC Software Solutions is an equal opportunities employer, welcoming applications from all communities. We’re NEC Software Solutions (part of global tech giant NEC Corporation). While you read this ad, our software is helping to dispatch ambulances, support families, keep trains on the move, locate missing people and even test the hearing of newborn babies.

Working with us, you’ll be helping our 3,000+ employees push the boundaries of what’s possible and support amazing public services.

We work with governments, hospitals, police forces, housing providers, local authorities and more. We help them pay financial support faster, speed up treatments for patients and respond to emergencies in the right way. We’d love your help.



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