Principal Medical Writing Scientist
Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Principle Medical Writing Scientist in to be located in Titusville, NJ, Spring House, PA, Raritan, NJ in the USA, or High Wycombe in the UK.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
Are you able to support our Oncology therapeutic area? You will:
- 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 applicants 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)
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