Director, Medical Writing

Meet Life Sciences Ltd.; États-Unis; Sur place; USD 180 000 - 230 000; Plein temps

Résumé du poste

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

This role will oversee two direct reports and collaborate with cross-functional teams to produce high-quality documents that meet scientific, quality, and regulatory standards. You will direct authoring, reviewing, and editing of protocols, CSRs, Investigator’s Brochures, and submissions, while partnering with clinical,

Qualifications

• 10+ years of medical writing experience within biotech, pharma, or the life sciences industry.
• Experience managing direct reports and external writing resources.
• 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.

Responsabilités

• Provide medical writing leadership across clinical development, with a focus on oncology programs.
• Manage and mentor two direct reports, overseeing workload planning, priorities, timelines, and deliverable quality.
• Oversee external vendors and contractors to ensure timely, high-quality deliverables.
• Author, review, and edit clinical and regulatory documents, including protocols, 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 oncology regulatory writing programs.

Connaissances

Scientific writing

Regulatory writing

Leadership

Cross-functional collaboration

Formation

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Description du poste

Our established biotech client is hiring a Director of Medical Writing! This position will provide strategic medical writing leadership across clinical development programs, supporting regulatory writing for oncology programs. The Director will oversee two direct reports and 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 programs.
• Manage and mentor two direct reports, overseeing workload planning, priorities, timelines, and deliverable quality.
• 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.
• 10+ years of medical writing experience within biotech, pharma, or the life sciences industry.
• Experience managing direct reports and/or external writing resources.
• 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.