Director, Medical Writing

The Director, Medical Writing is responsible for advancing the medical writing portfolio within the clinical and regulatory areas, authoring and overseeing the authoring of clinical documentation to support the conduct of trials and regulatory submissions/filings.

Requirements

• Bachelor's degree in science or related area; Master's/advanced degree preferred
• 12+ years in clinical or regulatory medical writing in biotech/pharma industry or 15+ years of relevant, cumulative biotech/pharma industry experience with at least 10 years regulatory Medical Writing experience
• Oncology experience required
• Significant experience in writing/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA)
• Advanced familiarity with all phases of drug development and a clinical operations organization
• Significant experience in working with drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with all regulatory documents (including CTA/IND submissions, protocols, investigator brochures, and clinical study reports)
• Significant experience managing/guiding internal cross-functional teams
• Experience in managing a functional team/overseeing the work of other writers/CROs/vendors
• Proven performance in earlier role/comparable role

Benefits

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses