Johnson & Johnson Careers
Principal Medical Writing Scientist
Titusville, New Jersey; Raritan, New Jersey; Spring House, Pennsylvania; High Wycombe, United Kingdom
Requisition ID: 4562190117
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.
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.
We are recruiting for a Principle Medical Writing Scientist in Titusville, NJ / Spring House, PA / Raritan, NJ in the USA, or High Wycombe in the United Kingdom.
In supporting our Oncology therapeutic area, you will perform the following:
- Prepare high quality clinical documents in terms of scientific content, as well as organization per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency. You will contribute scientifically and strategically to projects and project teams.
- Lead projects and drive strategies within processing/timeline constraints to meet unusual challenges. Lead submission-level, strategic activities for the writing team.
- Guide or train cross-functional team members, including external contractors, on processes and standard methodologies; coach or mentor more junior writers. You will lead the work of other medical writers, external contractors, and document specialists supporting a project.
- Collaborate while working in a team and take a dedicated role on multiple assigned projects with respect to timing, scheduling, and tracking.
- Minimum of a Bachelor’s degree / Master’s Degree in a relevant scientific discipline
- Experience in regulatory medical writing lasting at least 5 years
- Strong medical writing skills including interpreting and organizing scientific data.
- Experience writing clinical regulatory documents, such as, but not limited to clinical study reports, clinical study protocols, investigator’s brochures, clinical summary documents, regulatory responses, and briefing documents.
- Experience in project managing and working on teams
- In-depth knowledge of writing guidelines, such as ICH, FDA, AMA
- Knowledge of the end-to-end drug development process.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applications will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Titusville-
North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Janssen Research & Development, LLC. (6084)