Johnson & Johnson Careers
Principal Medical Writing Scientist
Requisition ID: 5176190520
Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Principal Medical Writing Scientist to be located in High Wycombe (United Kingdom) or Titusville, NJ / Spring House, PA / Raritan, NJ in the USA.
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.
The Principal Medical Scientist will support the Neuroscience therapeutic area by performing the following:
- Preparing and finalizing scientific and clinical documents of the highest scientific content and presentation quality, in accordance with established timelines and processes
- Managing projects and deciding on strategies within processing/timeline constraints and appropriate deviations from normal practice to meet unusual challenges
- Providing mentorship to junior writers as well as oversight of the work of other medical writers, external contractors, and document specialists supporting a project
- Collaborating while working in a team and taking a dedicated role on multiple assigned projects with respect to timing, scheduling, and tracking
- Contributing scientifically and strategically and leading submission-level, strategic activities for the writing team
- Identifying productivity improvement opportunities and help finding flexible solutions
- Negotiating with and influencing others with regard to scientific document content and processes
- Bachelor’s degree at a minimum (requirement) with higher degrees preferred (MS, PhD, PharmD, MD or equivalent) in a relevant discipline
- At least 5 years’ experience in regulatory medical writing is required
- Strong scientific, medical writing skills, including interpreting and organizing scientific data
- Experience writing clinical regulatory submission and safety documents, such as Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures, Health Authority Briefing and Response Documents, and CTD Summary Documents
- Experience in project management and work with cross-functional teams
- In-depth knowledge of writing guidelines, such as, ICH, FDA, AMA
- Strong 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-Pennsylvania-Spring House, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Janssen Research & Development, LLC. (6084)