Associate Director, Medical Writing

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Medical Writing.  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 Associate Director, Medical Writing will support our Oncology or Immunology Therapeutic Areas.   

Principal Responsibilities:

• Prepare and finalize all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy.  Work with a high level of independence and take a lead role on with respect to timing, scheduling, and tracking.
• Lead program-level/submission writing teams independently.
• Directly lead or set objectives for others on team projects and tasks.
• Guide or train cross‐functional team members on processes, best practices; coach or mentor more junior writers.
• Proactively identify and champion Medical Writing process improvements.
• Develop and present best practices to external audiences. 
• Lead cross‐functional/cross‐Therapeutic Area, cross‐Johnson & Johnson process improvement initiatives, or other process working group.
• If a lead writer for a program, act as the primary point of contact and champion for medical writing activities for the clinical team.  Plan and lead the writing group for assigned program.
• Lead discussions in Medical Writing and cross‐functional meetings as appropriate.
• Maintain and disseminate knowledge of industry, company, and regulatory guidelines.
• Interact with senior cross‐functional colleagues and external partners to strengthen coordination between departments.
• Able to represent Medical Writing in industry standards working groups.