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Regulatory Medical Writer
hace 2 meses
At Johnson & Johnson Innovative Medicine, we're dedicated to helping people live full and healthy lives. Our team is focused on discovering and developing innovative medical solutions to address important unmet medical needs in oncology, immunology, and other therapeutic areas.
Key Responsibilities:- Prepare and finalize clinical documents, including clinical study reports, investigator's brochures, study protocols, and regulatory responses.
- 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.
- Lead program-level or submission writing teams with supervision.
- Strong knowledge of regulatory guidelines and industry standards.
- Excellent writing and communication skills.
- Ability to lead cross-functional teams and mentor junior writers.
- Strong analytical and problem-solving skills.
We're looking for a highly skilled and experienced Senior Analyst to join our Oncology Regulatory Medical Writing team. If you have a passion for medical writing and a strong background in regulatory affairs, we encourage you to apply.
