Medical Writer

Quanticate; Bengaluru; On-site; INR 1,500,000 - 2,500,000; Full time

Benefits offered by this job

Competitive salary

Flexible hours

Holidays

Medical Insurance for self & family

Gratuity

Accidental coverage

Learning & development opportunities

Job summary

Quanticate International Limited is seeking a Medical Writer (Consultant) to lead and contribute to medical writing projects, collaborating with cross-functional teams and clients to produce accurate, regulatory-compliant documents.

The role involves mentoring junior writers, guiding process improvements, and supporting business development activities to ensure high-quality deliverables.

Qualifications

• Master's degree in Life Sciences, Medical Sciences, Pharmacy, or related field.
• A PhD, PharmD, MD, MVSc, or equivalent advanced qualification is desirable.
• 4+ years of medical writing experience in pharma/biotech/CRO/healthcare.
• Strong experience preparing regulatory and scientific documents.
• Solid understanding of regulatory requirements and scientific communication guidelines.
• Experience mentoring or supporting development of colleagues.
• Publications in peer-reviewed literature advantageous.

Responsibilities

• Author, review, and quality-check regulatory and scientific documents such as clinical study reports.
• Ensure documents reflect source data and comply with regulatory standards.
• Manage document review cycles and coordinate stakeholder feedback.
• Provide editorial support, proofreading, and quality control reviews.
• Support document publishing and submission-ready deliverables.
• Lead and collaborate with cross-functional project teams to meet timelines and budgets.
• Maintain project records, time reporting, and milestones.

Skills

Written and verbal communication

Project management

Stakeholder management

Analytical & problem-solving

Independent work in cross-functional

Education

Master's degree (Life Sciences/related)

PhD/MD/PharmD/MVSc or equivalent

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.

• 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)