Role Description
Join our Medical Writing team and play a key role in delivering high-quality scientific and regulatory documents that support clinical development programmes worldwide. As a Medical Writer (Consultant), you will lead and contribute to a variety of medical writing projects, collaborating with cross-functional teams and clients to ensure the delivery of accurate, compliant, and impactful documentation. You will also act as a subject matter expert, providing guidance to colleagues and supporting continuous improvement across the function.
What You'll Do
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Medical Writing & Document Development
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Author, review, and quality-check a range of regulatory and scientific documents, including clinical study reports and other medical writing deliverables.
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Ensure all documents accurately reflect source data, meet regulatory requirements, and comply with company and client standards.
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Manage document review cycles, resolve reviewer comments, and coordinate feedback from multiple stakeholders.
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Provide editorial support, proofreading, and quality control reviews where required.
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Support document publishing activities and compilation of submission-ready deliverables.
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Project Leadership & Delivery
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Manage multiple writing projects simultaneously, ensuring delivery within agreed timelines and budgets.
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Track project milestones, risks, and progress using project management tools.
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Collaborate closely with project teams, reviewers, and subject matter experts to ensure efficient project execution.
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Maintain accurate project records, including time reporting and tracking metrics.
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Client Partnership & Business Support
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Serve as a point of contact for clients on assigned projects.
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Build and maintain strong client relationships through professional communication and high-quality delivery.
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Support proposal development, bid defence meetings, and business development activities as required.
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Contribute to client satisfaction initiatives and provide feedback to support continuous service improvement.
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Mentoring & Knowledge Sharing
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Provide training, guidance, and mentorship to junior Medical Writers and team members.
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Promote knowledge sharing and best practices across the organisation.
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Support process improvement initiatives and help drive innovation within the Medical Writing function.
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Regulatory & Industry Expertise
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Stay current with evolving regulatory requirements, GCP standards, and scientific communication guidelines.
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Share regulatory updates and industry best practices with colleagues and clients.
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Engage with relevant industry forums and professional networks to maintain expertise and awareness of emerging trends.
Qualifications
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Master's degree in Life Sciences, Medical Sciences, Pharmacy, or a related scientific discipline.
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A PhD, PharmD, MD, MVSc, or equivalent advanced qualification is desirable.
Requirements
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4+ years of medical writing experience within the pharmaceutical, biotechnology, CRO, or healthcare sector.
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Strong experience preparing regulatory and scientific documents.
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Solid understanding of regulatory requirements and scientific communication guidelines.
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Experience mentoring or supporting the development of colleagues.
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Publications in peer-reviewed scientific literature would be advantageous.
Benefits
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Competitive salary
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Flexible working hours
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Holidays (Annual Leave, Sick Leave, Casual Leave and Bank holidays)
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Medical Insurance for self and immediate family
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Gratuity
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Accidental Coverage
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Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e-learning, job shadowing)