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Senior Medical Writing Scientist
Requisition ID: 0606180504
Janssen Research & Development, LLC., a member of the J&J Family of Companies, is recruiting for a Senior Medical Writing Scientist with primary location in Raritan, NJ. Other locations of Titusville, NJ and Spring House, PA will be considered. This position will support the Cardiovascular therapeutic area.
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. And we pursue the most promising science, wherever it might be found.
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. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Senior Medical Writing Scientist is responsible for preparing basic documents independently and less complex summary documents and regulatory responses under supervision. You will work as a member of a team and report to a, director. You will be an individual contributor, but may provide guidance to more junior writers.
- Prepare documents of high quality in terms of scientific content clarity, and accuracy, with attention to format and consistency as well as organization per applicable external (regulatory) and internal guidance.
- Engage in scientific collaboration with clinical and other functional areas to ensure integrity of documentation.
- Work in a team environment with greater independence for longer-term activities, and take an active role on assigned projects with respect to timing, scheduling, and tracking.
- Establish document timelines and strategies in accordance with internal processes, with guidance from functional management and the clinical team.
- Lead cross-functional document planning and review meetings.
- Learn and apply knowledge of regulatory guidance documents such as ICH requirements.
- A minimum of a Bachelor’s degree is required.
- An advanced degree (Masters, PhD, MD) is preferred.
- A minimum of 4 years relevant pharmaceutical/scientific experience is required.
- A minimum of 2 years relevant scientific writing experience (could be publications from pharma or academic research) is required.
- Experience using AMA, ICH or similar guidelines are preferred.
- Experience with medical writing document standards and processes is preferred.
- Experience with applicable word processing software is required.
- Experience working in teams and basic project management skills are required.
- The ability to stay organized, manage time and work on multiple documents/projects at the same time is required.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
United States-New Jersey-Raritan
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)