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.

Requirements

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

an annual target bonus
equity
a comprehensive suite of competitive benefits designed to support our employees’ overall well-being

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

medical writingclinical protocolsinvestigator brochuresclinical study reportsregulatory submissionsICH guidelinesGCPAI/ML techniquesdocumentation workflowsoncology programs

Soft Skills

leadershipcollaborationmentoringinfluence without authorityrelationship buildingoperational excellencecross-functional alignmentcommunicationstrategic planningquality control

Certifications

advanced degreeMSPharmDPhDMD