
Regulatory Medical Writer Leader
21 hours ago
We are seeking an experienced Regulatory Medical Writer Leader to join our team at Johnson & Johnson. The successful candidate will be responsible for leading a team of medical writers in the development of high-quality regulatory documents.
Key Responsibilities:
- Lead a team of medical writers in the preparation and finalization of clinical documents.
- Develop and implement processes to improve the efficiency and quality of medical writing.
- Mentor and coach junior staff members on document planning, processes, content, and provide peer review as needed.
- Actively participate in medical writing and cross-functional meetings.
- Maintain knowledge of industry, company, and regulatory guidelines.
Requirements:
- At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required.
- Oncology therapeutic area experience preferred.
- Excellent oral and written communication skills are pivotal to engage in cross-functional discussions.
- Expert project/time management skills.
- Able to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
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