Senior Medical Writer & Regulatory Strategy Lead

Discover International; Boston (MA); On-site; USD 120,000 - 190,000; Full time

Job summary

Discover International is seeking a Senior/Associate Director Medical Writer to lead regulatory document development across global clinical programs. You will partner with cross-functional teams, shape document strategy, timelines, and submission deliverables while ensuring scientific rigor and regulatory compliance.

This role offers significant ownership, mentorship of other writers, and the chance to influence program decisions that impact patients.

Qualifications

• Bachelor’s degree in a scientific, medical, or writing-related discipline.
• 5+ years of medical writing experience within pharma/biotech.
• Strong experience developing regulatory and clinical documentation for drug development.
• Experience leading multiple deliverables and coordinating writers/external resources.

Responsibilities

• Lead the development of regulatory and clinical documents (protocols, CSRs, IBs, briefing documents, clinical summaries, pediatric plans, responses to health authorities).
• Serve as lead writer and/or oversight for clinical content within regulatory submissions and global dossiers.
• Represent Medical Writing on cross-functional teams and contribute to program governance.
• Develop document strategies, resource plans, and timelines to support milestones.
• Coordinate internal stakeholders, external writers, and vendors to ensure high-quality deliverables.
• Mentor and support other medical writers while promoting standards and best practices.
• Drive quality and consistency across regulatory documentation and submissions.
• Partner with Clinical Development, Regulatory Affairs, Pharmacovigilance, Biostatistics and other functions.

Skills

Medical writing

Regulatory submissions

CTD/eCTD knowledge

Cross-functional collaboration

Mentoring/lead writer

Education

Bachelor’s degree in scientific/medical discipline

Advanced degree preferred

Job description

Discover International is seeking a Senior/Associate Director Medical Writer to lead regulatory document development across global clinical programs. You will partner with cross-functional teams, shape document strategy, timelines, and submission deliverables while ensuring scientific rigor and regulatory compliance.

This role offers significant ownership, mentorship of other writers, and the chance to influence program decisions that impact patients.