Medical Writer

Quanticate; United States; Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Flexible working hours

Holidays and leave

Medical Insurance for self and family

Gratuity

Accidental Coverage

Learning development opportunities

Job summary

Quanticate is seeking a Medical Writer (Consultant) to lead and contribute to regulatory and scientific documents across clinical development programmes worldwide.

You will collaborate with cross-functional teams, provide subject-matter guidance, and support continuous improvement in medical writing processes. The role emphasizes mentorship and client interaction within a data-focused CRO environment.

Qualifications

• Master’s degree in Life Sciences, Medical Sciences, Pharmacy, or related field.
• A PhD, PharmD, MD, MVSc, or equivalent advanced qualification is desirable.

Responsibilities

• Author, review, and quality-check regulatory and scientific documents (clinical study reports, etc.).
• Ensure documents reflect source data, meet regulatory requirements, and comply with standards.
• Manage document review cycles and coordinate feedback from multiple stakeholders.
• Provide editorial support, proofreading, and quality control reviews.
• Support document publishing activities and submission-ready deliverables.
• Manage multiple writing projects within timelines and budgets.
• Track milestones, risks, and progress using PM tools.
• Collaborate with project teams, reviewers, and subject matter experts.
• Maintain accurate project records, including time reporting and metrics.
• Serve as client point of contact and build strong relationships.
• Support proposal development and business development activities.
• Provide training and mentorship to junior writers.

Skills

Written communication

Verbal communication

Complex concept translation

Attention to detail

Organization & prioritisation

Analytical thinking

Independent working

Stakeholder management

MS Office proficiency

Continuous learning

Education

Master’s degree in Life Sciences or related field

PhD/MD/PharmD or equivalent (desirable)

Tools

Microsoft Office

Document management systems

Job 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

Medical Writing & Document Development

• Author, review, and quality-check a range of regulatory and scientific documents, including clinical study reports and other medical writing deliverables.
• Ensure all 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 where required.
• Support document publishing activities and compilation of submission-ready deliverables.

Project Leadership & Delivery

• Manage multiple writing projects simultaneously, ensuring delivery within agreed timelines and budgets.
• Track project milestones, risks, and progress using project management tools.
• Collaborate closely with project teams, reviewers, and subject matter experts to ensure efficient project execution.
• Maintain accurate project records, including time reporting and tracking metrics.

Client Partnership & Business Support

• Serve as a point of contact for clients on assigned projects.
• Build and maintain 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 to support continuous service improvement.

Mentoring & Knowledge Sharing

• Provide training, guidance, and mentorship to junior Medical Writers and team members.
• Promote knowledge sharing and best practices across the organisation.
• Support process improvement initiatives and help drive innovation within the Medical Writing function.

Regulatory & Industry Expertise

• Stay current with evolving regulatory requirements, GCP standards, and scientific communication guidelines.
• Share regulatory updates and industry best practices with colleagues and clients.
• Engage with relevant industry forums and professional networks to maintain expertise and awareness of emerging trends.

Quanticate is the world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming, statistics and data management input. We need talented individuals to help us fulfil our customers’ needs.

Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotechs that are taking their first steps in clinical development

We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.

What You’ll Bring

Qualifications

• 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.

Experience

• 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.

Skills & Competencies

• 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.

Quanticate will never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit and we do not ask or require candidates to deposit any money or complete any paid for courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at https://www.quanticate.com/careers-guidance.

• 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)