Remote Senior Medical Writing Lead, Regulatory Submissions

Beeline Medicines; United States; Remote; USD 181,000 - 235,000; Full time

Benefits offered by this job

Equity

Annual bonus

Comprehensive benefits

Job summary

Beeline Medicines, a clinical-stage biotechnology company, is seeking an Associate Director of Medical Writing. The role combines hands-on authorship with leadership of medical writing activities to support regulatory, nonclinical, and clinical documents for INDs and NDA/BLA components.

The position requires a PhD/PharmD/masters with 7+ years in medical writing, deep regulatory knowledge, and experience with ICH CTD. Remote work is available with periodic travel to offices as needed.

Qualifications

• Advanced degree (PhD, PharmD, or master's level) in life sciences, pharmacology, biomedical sciences, or related field.
• Minimum 7+ years of medical writing experience in pharma/biotech.
• Experience in regulatory submissions and ICH CTD formats (CSRs, ISS/ISE, IBs, IND/CTA).
• Strong knowledge of FDA/EMA writing requirements and ICH guidelines.

Responsibilities

• Own day-to-day medical writing activities, coordinating internal and external resources to deliver regulatory documents on time.
• Author and review clinical and regulatory documents (protocols, CSRs, IBs, SAPs, ICFs, INDs/CTAs, and NDA/BLA components).
• Lead strategy for submission narratives and ensure consistency across CTD modules.
• Collaborate with cross-functional teams to plan, sequence, and execute document deliverables.
• Provide guidance to internal contributors and external writers, manage vendors, and track deliverables.

Skills

Medical Writing

Regulatory Submissions

Cross-functional Leadership

Regulatory Strategy

Document Review

Education

PhD

PharmD

Master's degree

Tools

Veeva Vault

Electronic submission tools

Document management systems

Job description

Beeline Medicines, a clinical-stage biotechnology company, is seeking an Associate Director of Medical Writing. The role combines hands-on authorship with leadership of medical writing activities to support regulatory, nonclinical, and clinical documents for INDs and NDA/BLA components.

The position requires a PhD/PharmD/masters with 7+ years in medical writing, deep regulatory knowledge, and experience with ICH CTD. Remote work is available with periodic travel to offices as needed.