Janssen Research & Development, LLC. a Johnson and Johnson Company is hiring Global Regulatory Affairs Fellows . This position is designed for a new university hire; candidates must be recent university graduates.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
J&J thrives on a diverse company culture, celebrating the uniqueness of our employees and commitment to inclusion. It is also proud to be an equal opportunity employer.
The Global Regulatory Affairs (GRA) team is a key strategic partner supporting global research and development initiatives at Janssen. The fellowship program will provide a broad understanding of the global drug development process as well as strategies related to interactions and communications with appropriate health authorities while gaining hands-on experience through participating on cross-functional/cross therapeutic area project teams.
The Global Regulatory Affairs Fellowship Program is a one-year experiential program. As a participant of this program, fellows will support an individual project team in coordination and review of necessary documentation required for regulatory submissions to health authorities. Additionally, the fellows will develop necessary leadership skills and behaviors through carefully selected programs to become a leader in their respective healthcare field. During the year-around fellowship program, the fellows are expected to support the following key attributes of our corporate objectives:
Innovation – Innovation is our passion and mission as well as a fundamental requirement in our pursuit to create innovative, world-class drugs for our patients to improve and impact their lives.
Integrity – At Janssen, we are distinguished by our rich history of ethics and integrity. We strive to do what is right for our patients in a fair and transparent manner to improve the health and well-being of our patients worldwide.
Accountability – Accountability is the cornerstone of our culture. We demonstrate our compassion for patients and we work hard every day to honor our commitment for those who depend on us to develop innovative therapies to improve their lives.
All fellows will be required to complete a project for presentation to the GRA Senior Leadership Team and other internal stakeholders. They will attend internal and external cross-functional meetings in support of their roles and responsibility during their tenure in Janssen. They may be asked to review and assist in development and implementation of strategies for supporting the key development and marketed projects.
Candidates should have a PhD/Pharm D in Pharmacy or related Biological Sciences from an accredited academic institution with a strong academic track record. Candidates should have some fundamental understanding of pharmaceutical drug development. Ability to work with multi-functional project teams is a plus. Candidates should be highly motivated to work in the Pharmaceutical Industry and be a self-starter. To demonstrate this, academic excellence and leadership activities in an organizational setting is required. Knowledge of current Food and Drug Administration (FDA) regulations and guidelines is preferred but not required. Knowledge of current FDA/Regulatory Affairs submission requirements including eCTD format is preferred and knowledge of the logistics and work of the pharmaceutical industry is a plus.
Candidates will work independently as part of a matrix organization. The candidate must be self-motivated, productive, and team-oriented, with proven scientific problem-solving skills and an interest in the international context of healthcare systems and technology assessment. The candidate must also have excellent computer, verbal and written communication skills. Independence, creativity, and the impetus to challenge ideas are required, as well as the ability to work well in collaborative, cross-functional teams. Candidates are preferred to have demonstrated leadership capabilities and to have an excellent publication record and strong written and verbal communication skills.
These positions will be based in NJ or PA and will require local travel. to other sites in NJ and Pennsylvania.
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