Remote Senior Director, Medical Writing & Submissions

Lumicity; United States; A distancia; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

A biopharmaceutical company is looking for a Senior Director of Medical Writing to lead the creation of high-quality clinical and regulatory documents. This is a strategic position requiring 12+ years in medical writing along with team leadership skills. The role is remote, ideally located on the East Coast of the US. Responsibilities include overseeing document quality and compliance, managing timelines, and collaborating with cross-functional teams for successful drug development.

Formación

• 12+ years of experience in medical writing.
• Experience leading teams and managing external vendors.
• Strong background in regulatory documents and drug development.

Responsabilidades

• Lead strategy and delivery of clinical/regulatory documents.
• Manage external vendors and potentially build an internal medical writing team.
• Oversee timelines, resources, and document quality/compliance.

Conocimientos

Medical writing

Regulatory document preparation

Team leadership

Project management

Excellent writing skills

Educación

Bachelor's degree

Advanced degree preferred

Descripción del empleo

A biopharmaceutical company focused on rare diseases is seeking a Senior Director of Medical Writing to lead the development of high-quality clinical and regulatory documents across the drug lifecycle. The company is advancing late-stage programs for rare, serious conditions and preparing for future commercialization.

Key Responsibilities

• Lead strategy and delivery of clinical/regulatory documents (e.g., protocols, study reports, regulatory summaries)
• Manage external vendors and potentially build an internal medical writing team
• Oversee timelines, resources, and document quality/compliance (ICH/GCP/eCTD)
• Collaborate cross-functionally with R&D, regulatory, and data teams
• Drive process improvements, SOP development, and operational efficiency
• Ensure accurate, consistent, submission-ready documentation
• Support regulatory submissions and public disclosures (e.g., trial registries)

Qualifications

• Bachelor’s degree with 12+ years in medical writing (advanced degree preferred)
• Experience leading teams and managing external vendors
• Strong background in regulatory documents and drug development
• Knowledge of clinical research, biostatistics, and regulatory standards
• Excellent writing, data interpretation, and organizational skills
• Ability to manage multiple projects and meet tight deadlines

This role is remote in the US, East Coast strongly preferred