Associate Director, Medical Writing

Meet Life Sciences Ltd.; United States; Remote; USD 140,000 - 190,000; Full time

Job summary

Meet Life Sciences Ltd. seeks an Associate Director of Medical Writing to provide strategic leadership across clinical development programs, with a focus on regulatory writing for oncology and neurology.

You will develop high-quality documents and partner with cross-functional teams to ensure scientific, quality, and regulatory standards. The role includes overseeing external vendors, authoring and editing protocols, CSRs, and Investigator’s Brochures, and supporting INDs and NDAs.

Qualifications

• 8+ years of medical writing experience in biotech, pharma, or life sciences.
• Bachelor's degree required; advanced degree preferred.
• Experience with protocols, CSRs, Investigator’s Brochures, and regulatory submissions.
• Experience supporting INDs and NDAs, especially oncology regulatory writing.

Responsibilities

• Provide medical writing leadership across clinical development with focus on oncology and neurology.
• Oversee external vendors and contractors to ensure timely, high-quality deliverables.
• Author, review, and edit clinical and regulatory documents (protocols, CSRs, IIBs, regulatory submissions).
• Collaborate with clinical, regulatory, statistics, and pharmacovigilance teams to coordinate documents.
• Establish and improve medical writing processes, templates, quality standards, and review practices.
• Support regulatory submission planning and execution (INDs, NDAs, key clinical summary documents).

Skills

Scientific writing

Regulatory knowledge

Project leadership

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in a scientific field

Advanced degree preferred

Job description

Title: Associate Director, Medical Writing

Location: Remote

Our established biotech client is hiring a Associate Director of Medical Writing! This position will provide strategic medical writing leadership across clinical development programs, supporting regulatory writing for oncology and neurology programs. The Associate Director will collaborate with cross-functional teams to develop high-quality clinical and regulatory documents that meet scientific, quality, and regulatory standards.

Responsibilities

• Provide medical writing expertise and strategic guidance across clinical development teams, with a focus on oncology and neurology programs.
• Oversee external vendors and contractors to ensure timely, high-quality deliverables.
• Author, review, and edit clinical and regulatory documents, including protocols, Clinical Study Reports (CSRs), Investigator’s Brochures, and regulatory submissions.
• Partner with clinical, regulatory, statistics, and pharmacovigilance teams to coordinate document development and maintain alignment.
• Establish and improve medical writing processes, templates, quality standards, and review practices.
• Support regulatory submission planning and execution, including INDs, NDAs, and key clinical summary documents.

Preferred Skills & Qualifications

• Excellent scientific writing and editing skills with a strong understanding of clinical development and regulatory requirements.
• Experience managing complex writing projects across oncology programs.
• Strong leadership, communication, organizational, and cross-functional collaboration skills.
• Knowledge of US and international regulatory requirements, including eCTD structure and submission standards.
• Ability to manage competing priorities and work independently in a fast-paced biotech environment.

Education & Experience

• Bachelor’s degree in a scientific or related discipline required; advanced degree preferred.
• 8+ years of medical writing experience within biotech, pharma, or the life sciences industry.
• Hands-on experience developing clinical and regulatory documents, including protocols, CSRs, Investigator’s Brochures, and regulatory submission materials.
• Experience supporting INDs, NDAs, and oncology regulatory writing programs preferred.