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Medical Writer
Quanticate. Author, review, and quality-check regulatory and scientific documents, including clinical study reports and other medical writing deliverables.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing, regulatory compliance, and project management within the pharmaceutical and healthcare sectors. Capable of producing high-quality scientific documents while effectively managing stakeholder relationships and mentoring junior team members.
Highest-signal resume keywords
Medical Writing ExperienceRegulatory Requirements KnowledgeProject Management SkillsExceptional Communication SkillsMentoring Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Document PreparationScientific Document Quality ControlClinical Study Report WritingData AnalysisPublications in Peer-Reviewed Literature
Soft Skills
Attention to DetailProblem-Solving AbilitiesStakeholder ManagementNegotiation SkillsOrganisational Skills
Tools & Technologies
Microsoft OfficeDocument Management SystemsProject Management Tools
Certifications & Qualifications
Master's Degree in Life SciencesPhD, PharmD, MD, or Equivalent Advanced Qualification
Industry Keywords
Pharmaceutical SectorBiotechnologyCROHealthcareGCP Standards
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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