Clinical Medical Writer

Position Summary

We are seeking an experienced Clinical Medical Writer to support the development of high-quality clinical and regulatory documents for an oncology-focused biotechnology company. This individual will play a key role in advancing multiple late-stage clinical programs, with primary responsibility for authoring and coordinating clinical study documentation for Phase 2 and Phase 3 trials.

The ideal candidate is a collaborative, detail-oriented writer who thrives in a fast-paced, resource-efficient environment and is comfortable managing multiple studies simultaneously. This role requires close partnership with Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, and external vendors to ensure timely delivery of accurate, scientifically rigorous documents.

Key Responsibilities

• Author, edit, and manage clinical documents supporting Phase 2 and Phase 3 oncology clinical trials, including:
  • Clinical Study Protocols and protocol amendments
  • Investigator Brochures (updates)
  • Clinical Study Reports (CSRs)
  • Informed Consent Forms
  • Clinical sections of briefing books and meeting packages
  • Safety narratives and integrated clinical summaries, as needed
• Contribute to regulatory documents including:
  • IND submissions and amendments
  • Responses to Health Authority information requests
  • Annual reports
  • Other regulatory documents as required
• Manage writing activities for 2 3 concurrent clinical studies while balancing competing priorities and timelines.
• Lead document planning, timelines, and cross-functional review cycles from document kickoff through finalization.
• Collaborate with subject matter experts to translate complex scientific and clinical information into clear, accurate, and submission-ready documents.
• Ensure documents comply with ICH, GCP, company SOPs, and applicable regulatory guidance.
• Incorporate statistical outputs, clinical data, and safety information into clear scientific narratives.
• Coordinate document reviews, reconcile comments, and maintain version control throughout document development.
• Support preparation for regulatory interactions and major clinical milestones.
• Contribute to process improvements, document templates, and writing standards appropriate for a growing biotechnology organization.

Qualifications

• Advanced degree (PharmD, PhD, MD, MS, MPH, or equivalent scientific discipline) preferred; Bachelor's degree with significant relevant experience will be considered.
• 5 8+ years of medical writing experience in biotechnology, pharmaceutical industry, or CRO.
• Demonstrated experience authoring clinical documents for Phase 2 and Phase 3 clinical trials.
• Oncology clinical development experience required.
• Experience preparing Clinical Study Reports and clinical study protocols required.
• Working knowledge of regulatory submission documents (INDs, briefing documents, annual reports, responses to health authorities).
• Strong understanding of ICH E3, ICH E6, GCP, and FDA/EMA regulatory expectations.
• Ability to independently manage multiple writing projects with minimal supervision.
• Excellent project management, organization, and communication skills.
• Experience working within cross-functional clinical development teams.
• Proficiency with Microsoft Office and document management systems; familiarity with electronic document review platforms preferred.

Preferred Qualifications

• Experience supporting late-stage oncology development programs.
• Experience with immuno-oncology, virology, or targeted therapies is a plus.
• Experience supporting global clinical studies.
• Familiarity with submission publishing processes and electronic Common Technical Document (eCTD) structure.

Success in This Role

The successful candidate will:

• Produce high-quality clinical and regulatory documents that meet aggressive development timelines.
• Effectively manage writing activities across 2 3 active clinical studies simultaneously.
• Build strong partnerships with cross-functional stakeholders while driving documents to completion.
• Adapt comfortably within a collaborative, fast-moving biotech environment where flexibility and initiative are highly valued.
• Maintain scientific rigor, attention to detail, and regulatory compliance across all deliverables.

This position offers the opportunity to make a meaningful impact within a growing clinical-stage biotechnology company, contributing directly to the advancement of innovative oncology therapies through pivotal stages of clinical development.