Johnson & Johnson Loopbaan
Non- clinical scientific writer
Requisition ID: 1905743774W
Within Janssen Vaccines and Prevention B.V. (JVP, Leiden, The Netherlands), the Viral Vaccines department focuses on the research and development of vaccines against viral infectious diseases. Within this department, the Preclinical Immunology team evaluates the immunogenicity and efficacy of vaccine candidates against viral infectious diseases in animal models. The focus of the Preclinical immunology team is to conduct proof of concept studies to generate appropriate scientific data that enable vaccine candidates to progress from an early research stage towards clinical evaluation and clinical development.
For the Viral Vaccine Preclinical Immunology team, we are looking for a highly motivated non-clinical scientific writer or scientist with affinity for writing. The person we are looking for should have experience with the conduct of animal studies, preferentially with a background in the field of vaccines, immunology and/or virology. The writer will work closely with the scientists in the Preclinical Immunology team to generate nonclinical study reports, and in cross-functional teams to prepare regulatory documents. All communication and writing is done in English.
The role requires experience in scientific writing (English), and a background understanding of vaccines and in vivo disease models. The writer will primarily be responsible for the writing, review and completion of nonclinical study reports in collaboration with the responsible scientists. The writer will also be involved in the co-ordination and compilation of regulatory documents, such as document packages required for a pre-Investigational New Drug (IND) meeting, IND submissions, Investigators Brochures and Annual Safety reports.
The writer will work with different Preclinical Immunology team leaders on different vaccine programs. The writer will also work together with the nonclinical regulatory writer for the preparation and management of regulatory documents, including working with cross-functional teams from different company departments such as the clinical, regulatory and manufacturing teams. The role requires strong self-motivation and initiative, project management skills, accuracy and attention to detail, reliability, efficiency, flexibility, team player skills and enthusiasm.
Educational background and competencies:
• Master’s degree in the biomedical field; immunology or vaccine background an advantage
• Affinity for scientific writing
• Knowledge of clinical drug development and regulatory processes and procedures within clinical trials is advantageous but not required
• Capable of organizing multiple priorities and projects, and work independently within area of responsibility
• Accurate – Critical- Analytical - Communicative - Team player - Planning & organization
Janssen Vaccines & Prevention BV (8852)