Associate Director, Medical Writing
$170,000–$199,000 year
RemoteUnited States
Job Summary
Lead medical writing strategy and deliverables for INDs, CTAs, BLAs, or MAAs by collaborating with cross-functional SMEs to develop timelines and manage high-quality submissions from start to finish. Author key clinical, nonclinical, and regulatory documents including protocols, IBs, CSRs, and briefing books while ensuring compliance with FDA, EMA, and ICH standards. Oversee review cycles, coordinate QC, and advocate for industry best practices such as lean authoring across the team. Identify risks for submission activities and contribute to process improvements through document template development and training materials. Provide status updates to leadership and manage consultants for complex, high-stakes documents.
Required Qualifications
- Bachelor's degree in a scientific discipline
- Advanced degree (MS, PhD, MD, PharmD)
- A minimum of 8+ years of experience in regulatory medical writing
- Proven track record of successfully leading complex or high-stakes submissions
- Ability to manage multiple projects and timelines simultaneously
- Proven track record of authoring high-quality clinical and regulatory documents, including for complex document types
- Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements
- Expert in word processing software (e.g., Office) and document management systems (e.g., Veeva)
Desired Qualifications
- Advanced degree (MS, PhD, MD, PharmD) is a plus
- Bachelor's degree in Pharmacy, Chemistry, Biology, or related field
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