Senior Medical Writer/AD, Medical Writing - Regulatory

Job Title: Senior Medical Writer OR Associate Director, Medical Writing (Regulatory)

Location: Hybrid schedule in San Francisco, New Jersey, or New York

Position Overview: A bio-pharmaceutical company is seeking a highly skilled and experienced Senior Medical Writer or Associate Director, Medical Writing to join their team. In this role, you will lead and manage the medical writing activities across clinical, non-clinical and regulatory verticals. You will work closely with cross-functional teams to support regulatory submissions, clinical study reports, protocols, IBs, NDAs, and other key documents.

Key Responsibilities:

• Lead the development, review, and finalization of clinical, non-clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions.
• Collaborate with clinical and regulatory teams to ensure accurate and timely completion of documents.
• Provide strategic input and guidance on medical writing processes and best practices.
• Ensure compliance with regulatory requirements and company standards.

Qualifications:

• Minimum of 3 years of medical writing experience in the bio-pharmaceutical industry for the Senior Medical Writer level. Minimum of 6 years of medical writing experience to be considered for the Associate Director position.
• Proven track record of leading and managing medical writing projects.
• Strong understanding of regulatory requirements and guidelines (e.g., ICH, FDA, EMA).
• Excellent written and verbal communication skills.
• Ability to work effectively in a hybrid work environment and manage multiple priorities.

What We Offer:

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• Collaborative and inclusive work culture.
• Flexible hybrid work schedule.

Only available for US-based candidates. Don't hesitate to apply to learn more!