Senior Medical Writer, Clinical and Regulatory Strategic Communications

Prepare clinical regulatory documents including protocols, clinical study reports, participant narratives, and investigator's brochures

Prepare public-facing documents including informed consent forms, clinical trial registration and results postings, and plain language summaries

Design, plan, author, edit, and review accurate, clear, high-quality documents

Contribute scientifically and collaborate on document-specific cross-functional teams

Demonstrate team and project leadership responsibilities

Apply critical thinking, problem solving, and negotiation to challenges across documents, content, processes, timelines, and tools

Keep medical writing project leads and/or management informed and elevate issues affecting timelines, quality, or compliance

Use medical writing-specific tools and technology platforms

Participate in or lead initiatives improving medical writing processes and standards

Apply knowledge of clinical development, relevant regulations, disease areas, and company products

Support departmental needs such as orienting new team members and mentoring less experienced writers

May manage direct reports, including workload, professional development, and performance management

Demonstrates expertise in preparing clinical regulatory documents and public-facing materials while leading cross-functional teams. Possesses strong critical thinking, problem-solving, and communication skills essential for managing multiple projects in a deadline-driven environment.

Requirements

Bachelor's degree, preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health)

3+ years of relevant medical writing or industry experience

Experience managing multiple writing projects in a deadline-driven environment

Experience leading teams of medical writers and/or cross-functional team members

Ability to interpret clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines, with minimal supervision

Demonstrated critical thinking and problem-solving capabilities

Experience with conflict resolution and negotiation in cross-functional teams

Ability to adapt to changing project needs and unexpected workload demands

Strong oral and written communication and presentation skills

Technical expertise in Microsoft Office Suite and shared document systems such as SharePoint

Willingness to learn and adapt to emerging technology

Experience independently preparing clinical regulatory documents in accordance with regulatory requirements and industry guidelines

Knowledge of ICH GCP Guidelines, regulatory compliance, regulatory documents, regulatory submissions, medical writing, process improvements, project management, and technology platforms

No visa sponsorship

No valid driving license required

Core Competencies
Demonstrates expertise in preparing clinical regulatory documents and public-facing materials while leading cross-functional teams. Possesses strong critical thinking, problem-solving, and communication skills essential for managing multiple projects in a deadline-driven environment.

Highest-signal resume keywords

Clinical Regulatory Document Preparation

Team Leadership in Medical Writing

Critical Thinking and Problem Solving

Microsoft Office Suite Proficiency

Knowledge of ICH GCP Guidelines

ATS Optimization Keywords
Hard Skills

Medical Writing

Clinical Study Reports

Informed Consent Forms

Regulatory Submissions

Project Management

Document Review

Conflict Resolution

Data Interpretation

Process Improvements

Negotiation

Soft Skills

Oral Communication

Written Communication

Presentation Skills

Adaptability

Mentoring

Industry Keywords

Regulatory Compliance

Clinical Development

Life Sciences

Pharmacy

Public Health

Tools & Technologies

SharePoint

Document Management Systems

Medical Writing Tools

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