Senior Medical Writer

Job Summary

To support the preparation of clinical regulatory documents, the full-time Senior Medical Writer will manage writing projects, ensuring compliance with regulatory guidelines while working onsite in Florham Park, NJ.

Key responsibilities

• Manage assigned writing projects and ensure adherence to regulatory guidelines and templates
• Oversee the timely and high-quality completion of multiple medical writing deliverables
• Collaborate with key stakeholders and external resources to support medical writing activities

Required qualifications

• Bachelor of Science degree in Life Sciences, Nursing, Pharmacy, or a related discipline required
• Minimum of 7 years of medical writing experience within the pharmaceutical industry
• Experience as lead writer for key documents in major regulatory submissions
• Strong understanding of FDA and international regulations, ICH guidelines, and regulatory processes
• Proven ability to think critically and strategically while solving complex problems