Consultant Medical Writer

We are seeking an experienced Medical Writer to join us as an independent consultant. This role offers the opportunity to contribute to high-impact medical communications and regulatory documentation.

Job Title and Overview

Position: Consultant Medical Writer (Part-time)

Independent Contractor : Project-based with potential for ongoing collaboration

Location: Remote

About the Role

As a Consultant Medical Writer, you will be responsible for creating clear, accurate, and compelling medical and scientific content across various therapeutic areas. You will work closely with internal stakeholders from CQ Advisory, clinical experts, and external stakeholders to develop documents that meet regulatory requirements and effectively communicate complex medical information to diverse audiences.

This consultant position is ideal for an experienced medical writing professional who values independence while contributing to meaningful healthcare communications that can impact patient outcomes and advance medical knowledge.

Key Responsibilities and Duties

• Develop and write regulatory documents including Clinical Study Reports (CSRs), Clinical Study Protocols, Investigator Brochures, and regulatory submissions
• Create medical communications materials such as publications, abstracts, posters, and slide presentations for scientific conferences
• Draft and edit peer-reviewed manuscripts, systematic reviews, and meta-analyses
• Prepare educational materials for healthcare professionals and patients, including disease awareness content and treatment guidelines
• Collaborate with client cross-functional teams including clinical research, regulatory affairs, and medical affairs departments alongside the Medical Director
• Review and analyse clinical data, literature, and scientific information to ensure accuracy and compliance
• Maintain current knowledge of regulatory guidelines, industry standards, and therapeutic area developments
• Ensure all documents comply with relevant guidelines (ICH-GCP, FDA, EMA, etc.) and company standards
• Participate in project planning meetings and provide writing timeline estimates
• Conduct quality reviews and provide feedback on documents prepared by other medical writers engaged with CQ Advisory

Required Qualifications and Skills

Education and Experience

• Advanced degree (PhD, PharmD, MD, or Master's) in life sciences, medicine, pharmacy, or related field
• Minimum 3-5 years of professional medical writing experience in pharmaceutical, biotechnology, or CRO environment
• Proven track record of regulatory document preparation and submission support
• Experience in specific therapeutic areas of interest (oncology, hematology cardiology, respiratory medicine, neurology, etc.) would be highly regarded.
• Previous consulting or freelance medical writing experience would be helpful
• Publication record in peer-reviewed journals

Technical Skills

• Expert knowledge of medical writing principles, regulatory guidelines, and industry standards
• Experience with document management systems and electronic submission platforms
• Strong understanding of clinical trial processes and Good Clinical Practice (GCP)
• Knowledge of statistical concepts and ability to interpret clinical data

Professional Skills

• Exceptional written and verbal communication skills in English
• Strong attention to detail and commitment to accuracy
• Ability to work independently and manage time effectively
• Excellent project management and organizational abilities
• Proven ability to meet tight deadlines in a fast-paced environment

Consultant Terms and Conditions

Compensation and Payment

• Competitive hourly or project-based compensation commensurate with experience
• Consultant responsible for own tax obligations in their jurisdiction