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Working at Johnson & Johnson can change everything. Including YOU.
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 the UK 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”!
At Janssen Research & Development, LLC, we are united and energized by one mission - to discover and develop innovative medicines that ease patients' suffering, and solve the most important unmet medical needs of our time. As one of the Janssen Pharmaceutical Companies, our strategy is to identify the biggest unmet medical needs and match them with the best science, internal or external, to find solutions for patients worldwide. We leverage our world-class discovery and development expertise, and operational excellence, to bring innovative, effective treatments in five therapeutic areas:
- Cardiovascular and metabolism
- Immunology
- Infectious diseases and vaccines
- Neuroscience
- Oncology
Position summary:
Today’s changing healthcare environment presents many exciting challenges for Regulatory Affairs (RA) professionals. RA professionals within Janssen have opportunities to participate in high-level forums that connect government agencies and industry leaders to shape a complex policy ecosystem.
They are passionate about protecting our customers while ensuring that our business complies with all product-related regulations. RA professionals are involved in all stages of the product lifecycle, so they have numerous opportunities to contribute innovative ideas, product improvements, and service models that advance the health and well-being of patients and consumers. And because they have such a broad perspective on our business activities and product lifecycles, RA professionals find many opportunities to move their careers in a direction that aligns with their individual interests and passions.
As a RA placement student in the EMEA (Europe, Middle-East and Africa) Haematology and Oncology team, you will be responsible for conducting a research project on a topic impacting the regulatory function and business as a whole, and getting involved in the effective management of product registration activities in EMEA to ensure that registrations are conducted in a timely manner in accordance with regulatory and company requirements.
Main duties and responsibilities
- Conduct a research project on a topic impacting the regulatory function and business as a whole
- Assist in the preparation of national clinical trial applications for products in development.
- Liaise with internal departments and worldwide regulatory colleagues to support product registration activities
- Facilitate product registration activities in EMEA by compiling regulatory submissions and requested documentation to the European Medicines Agency, and regulatory affiliates in EMEA
- Maintain regulatory and registration databases, including archiving, purchase requisitions and control of standards, and analyze data to provide reports to immediate manager as required
- Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance to enable the site to achieve and maintain excellent results
Qualifications
Requirements of the role
- 2 years of degree level study completed
- A minimum of 2:1 achieved in first year of study
- Scientific degree type is preferable
Key skills and competencies
- Excellent planning and organizational skills
- Communication – listener, learner and thinker
- Thorough and flexible
- Cross-culturally aware
- Team player
- Enthusiastic and committed
- Excellent knowledge of Microsoft office PC packages
- Excellent written and verbal communication skills
- Good presentation skills
