Johnson & Johnson Careers
Manager, Medical Writing
Requisition ID: 6485190606
Janssen Research and Development, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Manager, Medical Writing to support our Oncology therapeutic area. The position will be located in Titusville, NJ / Spring House, PA / Raritan, NJ
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 Scientific Affairs, LLC is part of the Janssen Pharmaceutical Companies.
Are you ready to join our Oncology writing team? You will:
- Write all types of clinical documents, taking a lead role with respect to content and scientific strategy
- Lead submission-level activities for the writing team, driving strategies within timeline constraints to meet unusual challenges
- Work with a high level of independence, taking responsibility on your assigned projects for timing, scheduling, and tracking
- Champion medical writing standard processes and provide recommendations for departmental process improvements
- Prepare documents of high quality, with attention to format and consistency, and adherence to regulatory and internal guidelines.
- Coach or mentor more junior writers. You may lead the work of other medical writers, external contractors, and document specialists supporting a project
- This position
has no direct reports
- Minimum of a Bachelor’s degree / Master’s Degree in a relevant scientific discipline
- Experience in regulatory medical writing of at least 6 years is required
- 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 is required
- Experience writing Risk Management Plans is desired
- Strong project management skills and leadership skills (influencing, assertiveness, conflict management) is desired
- Strong interpersonal skills and the ability to resolve complex problems while working collaboratively across functional areas on large project teams is desired
- 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
Janssen Research & Development, LLC (6084)