Senior Medical Writing Lead for Clinical & Regulatory

Calico Life Sciences; South San Francisco (CA); On-site; USD 230,000 - 240,000; Full time

Benefits offered by this job

Two annual cash bonuses

Onsite work environment

Job summary

A biotech research company in South San Francisco seeks an Associate Director of Medical Writing to lead the development of high-quality clinical and regulatory documents. The ideal candidate must possess a Master's degree and over 8 years of experience in scientific writing at a biotech or pharmaceutical company. Responsibilities include document leadership, vendor management, and process improvement. A strong understanding of regulatory requirements and excellent communication skills are essential. The estimated salary range is $230,000 - $240,000 with additional bonuses.

Qualifications

• Minimum 8+ years of experience in scientific or medical writing.
• Expert knowledge of clinical regulatory document types.
• Excellent organizational skills with quality results.
• Self-motivated, collaborative, with a positive attitude.

Responsibilities

• Lead medical writing for clinical programs and documents.
• Ensure high-quality regulatory submissions.
• Develop medical writing best practices.

Skills

Scientific or medical writing

Regulatory document knowledge

Microsoft Office Suite

Detail-oriented mindset

Excellent communication skills

Education

Master’s degree in life science

PharmD or PhD preferred

Tools

Adobe Acrobat

SharePoint

Veeva RIM

Job description

A biotech research company in South San Francisco seeks an Associate Director of Medical Writing to lead the development of high-quality clinical and regulatory documents. The ideal candidate must possess a Master's degree and over 8 years of experience in scientific writing at a biotech or pharmaceutical company. Responsibilities include document leadership, vendor management, and process improvement. A strong understanding of regulatory requirements and excellent communication skills are essential. The estimated salary range is $230,000 - $240,000 with additional bonuses.