Medical Writer
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Job Description
Medical Writer authoring clinical and regulatory documents for Quanticate, a global data-focused CRO. Leading projects, supporting clients, and mentoring writers across clinical development programmes.
Responsibilities:
- Author, review, and quality-check regulatory and scientific documents, including clinical study reports and other medical writing deliverables.
- Ensure documents accurately reflect source data, meet regulatory requirements, and comply with company and client standards.
- Manage document review cycles, resolve reviewer comments, and coordinate feedback from multiple stakeholders.
- Provide editorial support, proofreading, and quality control reviews.
- Support document publishing and compilation of submission-ready deliverables.
- Manage multiple writing projects within agreed timelines and budgets.
- Track project milestones, risks, and progress using project management tools.
- Collaborate with project teams, reviewers, and subject matter experts.
- Maintain project records, including time reporting and tracking metrics.
- Serve as a client point of contact and maintain client relationships.
- Support proposal development, bid defence meetings, and business development activities.
- Contribute to client satisfaction and service improvement initiatives.
- Train, guide, and mentor junior Medical Writers and team members.
- Promote knowledge sharing, best practices, process improvement, and innovation.
- Stay current with regulatory requirements, GCP standards, and scientific communication guidelines.
- Share regulatory updates and industry best practices with colleagues and clients.
- Engage with industry forums and professional networks.
Requirements:
- Master's degree in Life Sciences, Medical Sciences, Pharmacy, or a related scientific discipline.
- A PhD, PharmD, MD, MVSc, or equivalent advanced qualification is desirable.
- 4+ years of medical writing experience within the pharmaceutical, biotechnology, CRO, or healthcare sector.
- Strong experience preparing regulatory and scientific documents.
- Solid understanding of regulatory requirements and scientific communication guidelines.
- Experience mentoring or supporting the development of colleagues.
- Publications in peer-reviewed scientific literature would be advantageous.
- Exceptional written and verbal communication skills.
- Ability to translate complex scientific concepts into clear, concise, and audience-appropriate content.
- Strong attention to detail and commitment to quality.
- Excellent organisational, project management, and prioritisation skills.
- Strong analytical and problem-solving abilities.
- Ability to work independently while contributing effectively within cross-functional teams.
- Confident stakeholder management, influencing, and negotiation skills.
- Proficiency with Microsoft Office and document management systems.
- Commitment to continuous learning and professional development.
Benefits:
- Competitive salary
- Flexible working hours
- Holidays (Annual Leave, Sick Leave, Casual Leave and Bank holidays)
- Medical Insurance for self and immediate family
- Gratuity
- Accidental Coverage
- Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e- learning, job shadowing)
- Membership to professional societies
- Career development opportunities
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