Medical Writer

Quanticate; India; On-site; INR 1,200,000 - 1,900,000; Full time

Benefits offered by this job

Membership to professional societies

Job summary

Quanticate is seeking an experienced Medical Writer (Consultant) to lead and contribute to regulatory and scientific documents that support global clinical programmes. You will mentor colleagues and promote continuous improvement while delivering accurate, compliant manuscripts.

You will author, review, and quality-check studies, manage multiple writing projects, collaborate with cross-functional teams, and support client relationships and business development efforts.

Qualifications

• Master's degree in Life Sciences or related field; PhD/MD/PharmD desirable.
• 4+ years of medical writing experience in pharma, biotech, CRO, or healthcare.
• Experience in regulatory and scientific document preparation.
• Strong understanding of regulatory guidelines.

Responsibilities

• Author, review, and quality-check regulatory and scientific documents.
• Lead project writing tasks, manage reviews, and coordinate stakeholders.
• Provide editorial support, proofreading, and quality control.
• Support publishing and submission-ready deliverables.

Skills

Medical writing

Regulatory writing

Editorial proficiency

Project management

Stakeholder management

Education

Master's degree in Life Sciences or related

PhD/MD/PharmD 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

• 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