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  4. Regulatory Medical Writing Graduate Programme 2022
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For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in EMEA are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential.

No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Sector summary

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. We discover and develop innovative medical solutions to address unmet medical needs across a range of disease areas. Visit https://www.janssen.com/ to learn more.

Position summary

We are seeking highly motivated candidates to join us in our inaugural Regulatory Medical Writing (RMW) Academy which sits within our Integrated Data, Analytics, and Reporting (IDAR) Academy. The Academy is a premier training program focused on developing and inspiring talent considering a career in pharmaceutical research and development. You can help advance our medicines in development at Janssen!

RMW writes high quality clinical documents to support the development, regulatory approval, and maintenance of our products. These documents include clinical protocols, investigator’s brochures, and clinical study reports, as well as detailed summaries of efficacy and safety and responses to health authority questions.

How you can make a difference: Apply your excellent writing skills, ability to interpret and summarize statistical and medical information, and attention to detail to the design of our clinical trials and reporting of our data.

Qualifications

Educational requirements

  • Bachelor’s degree and/or equivalent achieved by July 2022.
  • Biological science, medicine, or science/health-related degrees preferred.

Skills required

  • Ability to effectively apply knowledge and skills in a complex environment.
  • Good written and verbal communication skills.
  • Good problem solving and decision making. 
  • Ability to work in a team environment and independently as needed.
  • Strong attention to detail

Other IDAR Functions

IDAR is made up of the following other functions: Risk Management and Central Monitoring (RM-CM), Clinical & Statistical Programming (C&SP), Data Management (DM), IDAR Business Operations (IBO), and Clinical Data Standards & Transparency (CDS&T).

  • RM-CM leads the risked based approach to monitoring clinical trials, ensuring protection of human subjects and the quality of clinical trial data. The RM-CM group is responsible for early detection, analysis, and mitigation of potential risks in a clinical trial. 
  • C&SP provides analytical programming solutions that enable early and effective decisions. The role within C&SP plans, designs, and develops statistical programs in support of clinical research analysis and reporting activities. C&SP collaborates with biostatistics and other departments to achieve project goals. 
  • DM provides data delivery and analytics expertise in the conduct of our clinical trials. The aim is to deliver a database that is ready for statistical analysis and meets the standards for potential submission to regulatory authorities. 
  • IBO drives the development and implementation of aligned solutions to support IDAR’s strategy and to ensure business operational excellence.
  • CDS&T delivers easy-to-use, fit-for-purpose standards to ensure our stakeholders deliver regulatory-compliant data packages. We also operationalize regulatory requirements around data transparency to increase data utility while maintaining patient privacy and company confidentiality.