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Regulatory Document Specialist

1 week ago

Toronto, Ontario, Canada Johnson & Johnson Full time
About Our Team:

We are a collaborative and dynamic team of medical writers, editors, and subject matter experts dedicated to creating high-quality clinical and regulatory documents that support our company's mission. Our team is passionate about making a difference in the lives of patients and is committed to excellence in all aspects of our work.

We are seeking a highly skilled Medical Writer Lead to join our team in North America, Europe, or other global locations. The successful candidate will be responsible for writing and coordinating complex documents, including CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.

Purpose:
- The successful candidate will have strong leadership skills and the ability to function as a lead writer on most compounds under supervision.

Key Responsibilities:
- Write or coordinate clinical and regulatory documents, including planning and review meetings with cross-functional colleagues.
- Establish document timelines and strategies in accordance with internal processes.
- Complete time reporting, training, metrics database, and project tracking updates as required in relevant company systems.

Requirements:
- A university degree in a scientific discipline is required; an advanced degree is preferred.
- At least 6 years of pharmaceutical/scientific experience and 4 years of medical writing experience are required.
- Strong leadership skills, attention to detail, and excellent communication skills are essential.

Why Join Us:
- Develop your expertise in creating high-quality clinical and regulatory documents.
- Gain experience in leading cross-functional teams and establishing document strategies.
- Participate in process working groups and contribute to the development of best practices in medical writing.