Principal Medical Writing Scientist (1 of 2)

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Principal Medical Writing Scientist.  The primary location for this position is the United States.  Secondary locations are Canada, United Kingdom, Switzerland, Netherlands, Belgium, Germany, Spain and France.  This is a global role and is open to other countries.  Remote work options may be considered on a case-by-case basis and if approved by the company.

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.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension.  Please visit http://www.janssenrnd.com for more information.

The Principal Medical Writing Scientist will support our Oncology or Immunology Therapeutic Areas.

Principal Responsibilities:

• Prepare and finalize clinical documents such as, but not limited to, clinical study reports, investigator's brochures, study protocols, summary documents, risk management plans, regulatory responses, and briefing documents.
• Lead cross-functional document planning and review meetings.  Interact with peer writers and colleagues from other departments.  Able to lead program-level or submission writing teams with supervision.  Able to lead process working groups.
• Coach or mentor more junior writers on document planning, processes, content, and provide peer review as needed.
• Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
• If a lead writer for a program: Be the primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning, setting strategy, and leading writing group for assigned program.
• Maintain and apply knowledge of the industry, company, and regulatory guidelines.