Manager, Medical Writing

Manager, Medical Writing 

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.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, pulmonary hypertension, and cardiovascular and metabolic diseases.

We are recruiting for a Manager to join the Medical Writing team to support our immunology or oncology therapeutic areas. This is an individual contributor position (no direct reports). The position may be located in UK, Netherlands, Belgium, Switzerland, Germany, Spain, France, Canada or US. 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. Candidates selected for interview may be considered for equivalent role in another therapeutic area. Are you ready to join our team? Then please read further!

Key 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. Take a lead role with respect to content and scientific strategy.
• 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 general supervision. Able to lead process working groups.
• Coach or mentor more junior writers on document planning, processes, content, and provide peer review as needed. You may lead the work of other medical writers, external contractors, and document specialists supporting a project.
• Responsible for establishing document timelines and strategies in accordance with internal processes, with minimal guidance.
• If a lead writer for a program: 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.
• Work with a high level of independence, taking responsibility on assigned projects for timing, scheduling, and tracking.
• Champion medical writing standard processes and provide recommendations for departmental process improvements.
• Maintain and disseminate knowledge of the industry, company, and regulatory guidelines.