Parabilis Medicines · 9 hours ago
Senior Director, Medical Writing
United States
Full-time
Remote
Director/Executive
$250K/yr - $300K/yr
15+ years expParabilis Medicines is a clinical-stage biopharmaceutical company focused on developing innovative therapies for challenging protein targets. The Senior Director, Medical Writing will lead the medical writing strategy for clinical development programs, ensuring high-quality documentation and regulatory compliance while collaborating with cross-functional teams.
Biotechnology
Responsibilities
Lead medical writing strategy and execution across clinical development programs, ensuring timely delivery of high-quality documents aligned to corporate and regulatory objectives
Collaborating with the Clinical Leader, serve as the chief author or lead reviewer for key documents including: Clinical Protocols and Amendments, Investigator Brochures, Clinical Study Reports (CSRs), Informed Consent Forms, Regulatory submission components (e.g., IND/IMPD documents, briefing books, safety updates, module content), Clinical-scientific narratives and safety summaries
Partner with Regulatory and Clinical leaders to develop documentation plans and timelines for major milestones (Phase transitions, Health Authority meetings, submissions)
Oversee and manage external writing vendors, freelancers, and CRO deliverables; ensure consistent standards, templates, style guides, and quality control processes
Develop and maintain medical writing templates, SOPs, and best practices to support high-quality, efficient document generation across the organization
Ensure all documents meet ICH, GCP, and global regulatory requirements
Contribute to story development, message alignment, and scientific accuracy across Parabilis’ clinical and regulatory communications
Mentor cross-functional authors and reviewers on writing best practices and effective documentation strategies
Play a leadership role within Clinical Operations, helping drive operational excellence, cross-functional alignment, and a patient-focused mindset
Qualification
Required
Advanced degree in a scientific discipline (MS, PharmD, PhD, MD) or equivalent experience
15+ years of relevant medical writing experience in the biotechnology or pharmaceutical industry, including leading writing strategy for clinical-stage programs
Proven expertise with clinical and regulatory documents (protocols, CSRs, IBs, regulatory submissions)
Proven track record of delivery and utilization of new techniques & approaches such as AI/ML to ensure efficiency and accurate production of documents
Strong understanding of GCP, ICH guidelines, and global regulatory expectations
Experience working in cross-functional, fast-paced development environments
Demonstrated ability to manage vendors and complex documentation workflows
Experience supporting early-phase oncology programs
Experience preparing documentation for Health Authority interactions (FDA, EMA)
Familiarity with novel modalities, platform technologies, or mechanisms requiring clear scientific translation
Ability to influence without authority and build trusted relationships across functions
Benefits
Annual target bonus
Equity
Comprehensive suite of competitive benefits designed to support our employees’ overall well-being
Company
Parabilis Medicines
Parabilis Medicines™ is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for people living with cancer.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Mathai Mammen, M.D., Ph.D.
Chairman, CEO and President
Weiqing Zhou
Co-founder & COO
Recent News
Google Patent
2025-05-04
Google Patent
2025-05-04
Company data provided by crunchbase