Senior Medical Writer
hace 2 días
Job Summary
We are seeking a highly skilled Senior Analyst to join our Oncology Regulatory Medical Writing team at Johnson & Johnson Innovative Medicine. As a key member of our team, you will be responsible for preparing and finalizing clinical documents, leading cross-functional document planning and review meetings, and coaching junior writers.
About the Role
- Prepare and finalize clinical documents, including 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, interacting with peer writers and colleagues from other departments.
- Coach or mentor junior writers on document planning, processes, content, and provide peer review as needed.
- Establish document timelines and strategies in accordance with internal processes, with mentorship from functional management and clinical team as needed.
- As 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.
About Johnson & Johnson
At Johnson & Johnson, we are committed to 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. Our research and development efforts are dedicated to discovering and developing innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases, and vaccines, pulmonary hypertension, and cardiovascular and metabolic diseases.
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