Senior Regulatory Medical Writer, Immunology
2 settimane fa
At Johnson & Johnson, we are committed to helping people live full and healthy lives. Our Innovative Medicine (IM) division focuses on developing innovative medical solutions to address complex diseases. We are seeking a Senior Analyst, Immunology Regulatory Medical Writing to support our Immunology therapeutic area.
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.
- A minimum of a Bachelor's degree is required.
- Advanced degree (Masters, PhD) preferred.
- A minimum of 6 years of relevant pharmaceutical/scientific experience is required.
- A minimum of 4 years of relevant medical writing experience is required.
- Authoring experience with investigator brochures, clinical study protocols, and clinical study reports.
- Competitive compensation and benefits package.
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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