Medical Writer

Quanticate

3d

About The Position

Join Quanticate’s Medical Writing team to deliver high-quality scientific and regulatory documents supporting clinical development programmes worldwide. The Medical Writer (Consultant) leads and contributes to medical writing projects, working with cross-functional teams and clients to produce accurate, compliant, and impactful documentation. The role also serves as a subject matter expert, guides colleagues, and supports continuous improvement across the function.

The position involves developing and quality-checking regulatory and scientific documents, managing review cycles, coordinating stakeholder feedback, supporting publishing activities, and ensuring submission-ready deliverables. It also includes managing multiple projects, timelines, budgets, and project records; serving as a client contact; supporting business development; mentoring colleagues; and keeping current with regulatory requirements, GCP standards, and scientific communication guidance.

Quanticate is a data-focused CRO that supports customers conducting clinical trials, from global pharmaceutical companies to small biotechnology companies. The company encourages career development through professional society membership and involvement in professional activities and committees.

Requirements

• Master's degree in Life Sciences, Medical Sciences, Pharmacy, or a related scientific discipline.
• At least 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.
• Exceptional written and verbal communication skills.
• Ability to translate complex scientific concepts into clear, concise, 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 and contribute 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.

Nice To Haves

• A PhD, PharmD, MD, MVSc, or equivalent advanced qualification.
• Publications in peer-reviewed scientific literature.

Responsibilities

• Author, review, and quality-check clinical study reports and other regulatory and scientific 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 as required.
• Support document publishing and compilation of submission-ready deliverables.
• Manage multiple writing projects, delivering within agreed timelines and budgets.
• Track project milestones, risks, and progress using project management tools.
• Collaborate with project teams, reviewers, and subject matter experts to support efficient project execution.
• Maintain accurate project records, including time reporting and tracking metrics.
• Serve as a client contact on assigned projects and build strong client relationships through professional communication and high-quality delivery.
• Support proposal development, bid defence meetings, and business development activities as required.
• Contribute to client satisfaction initiatives and provide feedback for continuous service improvement.
• Train, guide, and mentor junior Medical Writers and team members.
• Promote knowledge sharing and best practices across the organisation.
• Support process improvement initiatives and innovation within the Medical Writing function.
• Stay current with regulatory requirements, GCP standards, and scientific communication guidelines; share updates and best practices with colleagues and clients.
• Engage with relevant industry forums and professional networks to maintain expertise and awareness of emerging trends.

Benefits

• Competitive salary
• Flexible working hours
• Holidays, including annual leave, sick leave, casual leave, and bank holidays
• Medical insurance for the employee and immediate family
• Gratuity
• Accidental coverage
• Learning and development opportunities, including mentoring, coaching, e-learning, and job shadowing

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level