Medical Writer

This is a fully remote position, open to applicants in India.

📋 Description

• Author, review, and conduct quality checks on regulatory and scientific documents, such as clinical study reports and other medical writing outputs.

• Ensure that documents accurately represent source data, fulfill regulatory obligations, and adhere to both company and client standards.

• Oversee document review cycles, address reviewer feedback, and coordinate responses from various stakeholders.

• Provide editorial assistance, proofreading, and quality control evaluations.

• Assist in document publishing and the assembly of submission-ready materials.

• Handle multiple writing projects within established timelines and budget constraints.

• Monitor project milestones, risks, and progress utilizing project management tools.

• Collaborate with project teams, reviewers, and subject matter experts.

• Maintain project documentation, including time tracking and metric monitoring.

• Act as a point of contact for clients and nurture client relationships.

• Aid in proposal development, bid defense meetings, and business development efforts.

• Contribute to client satisfaction and initiatives aimed at service enhancement.

• Train, guide, and mentor junior Medical Writers and team members.

• Foster knowledge sharing, best practices, process enhancements, and innovation.

• Stay updated on regulatory requirements, GCP standards, and scientific communication protocols.

• Disseminate regulatory updates and industry best practices to colleagues and clients.

• Engage with industry forums and professional networks.

⛳️ Requirements

• Master’s degree in Life Sciences, Medical Sciences, Pharmacy, or a related scientific field.

• A PhD, PharmD, MD, MVSc, or an equivalent advanced qualification is preferred.

• Over 4 years of medical writing experience in the pharmaceutical, biotechnology, CRO, or healthcare industries.

• Strong expertise in preparing regulatory and scientific documents.

• Comprehensive understanding of regulatory requirements and scientific communication protocols.

• Experience in mentoring or aiding the professional growth of colleagues.

• Publications in peer-reviewed scientific journals would be a plus.

• Outstanding written and verbal communication abilities.

• Capability to convert complex scientific ideas into clear, concise, and audience-appropriate text.

• Strong attention to detail and a commitment to quality.

• Excellent organizational, project management, and prioritization skills.

• Robust analytical and problem-solving skills.

• Ability to work autonomously while effectively contributing to cross-functional teams.

• Confident in stakeholder management, influencing, and negotiation.

• Proficient in Microsoft Office and document management systems.

• Dedication to continuous learning and professional growth.

🏝️ Benefits

• 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 provides various learning and development opportunities to facilitate your advancement (mentoring, coaching, e-learning, job shadowing)

• Membership to professional societies

• Career development opportunities