Regulatory Medical Writing Placement Student 2022

Diversity, equity, and inclusion have been part of the cultural fabric at Johnson & Johnson for more than 130 years. The success of our business depends on having the best talent in our workforce, reflecting the diverse markets we serve around the world, with a culture that values different perspectives and life experiences. At Johnson & Johnson, we foster an inclusive environment where diverse backgrounds, perspectives and experiences are valued, and where everyone feels they belong and can reach their full potential. Our commitment to respect the dignity and diversity of all is embedded in our Credo and woven into our everyday business practices. At Johnson & Johnson, no matter who you are, “You Belong”.

Sector Summary

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

Position Summary

We are seeking highly motivated candidates to join us as a Regulatory Medical Writing Scientist Placement Student in our Regulatory Medical Writing (RMW) department. This position will be part of our Integrated Data Analytics and Reporting (IDAR) Academy, a premier training program focused on developing and inspiring talent in those considering a career in pharmaceutical research and development.

Regulatory Medical Writing prepares 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 summaries of efficacy and safety and responses to health authority questions.

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

Upon successful completion of your training your main responsibilities may include (but not be limited to):

• Prepare sections of documents or write basic documents under close supervision, such as protocol/report shells, narratives, simple protocol amendments, and Investigator’s Brochure updates.
• Assist with document quality control, abbreviations, references, literature searches, table creation, and other tasks.
• Learn and follow standard operating procedures, templates, best practices, policies, and style guides.
• Attend cross-functional meetings with other writers as appropriate (eg, project kick-off and review meetings).

The Regulatory Medical Writing Scientist Placement Student may also get the opportunity to contribute to departmental innovation, process improvement initiatives, or exploratory research projects.

Qualifications

Educational Requirements

• Successful completion of the first 2 years of a degree course.
• A minimum of a 2:1 achieved in the first year.
• Biological/Life Sciences or similar scientific degrees preferred.

Skills Required

• Ability to effectively apply knowledge and skills in a complex environment.
• Solid oral and written communication skills.
• Attention to detail.
• Ability to function in a team environment and independently as needed.
• Organizes time well with short-term responsibilities.
• Demonstrates learning agility.

Please note that we plan to close for first round of applications on 14th November, but could close earlier if we receive too many applications

Other IDAR Functions

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

• 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.
• 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. 
• 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.