Clinical document formatting

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Inviting applications for the role of Specialist-Clinical document formatting

Work location: Mumbai

The Manager is responsible for leading a team that supports clinical document formatting, document publishing, CSR coordination, and ISI Toolbox activities. The role ensures high-quality, compliant, and timely delivery of clinical and regulatory documents in accordance with organizational and industry standards.

Key Responsibilities

1. Team Leadership & People Management

• Lead, mentor, and develop a team of document specialists and word formatter.
• Allocate resources and prioritize work to meet project timelines.
• Monitor team performance, productivity, and quality metrics.
• Conduct regular team meetings, performance discussions, and training sessions.
• Drive continuous improvement initiatives and operational excellence.

2. Clinical Document Formatting

• Formatting of clinical and regulatory documents like Protocol, IB, SAP, redline of protocol according to company and client standards.
• Search literature reference document and update the reference sections.
• Ensure consistency in templates, styles, pagination, TOCs, bookmarks, and hyperlinks.
• Review formatted documents for compliance with submission requirements and quality standards.
• Implement process improvements to enhance formatting efficiency and accuracy.

3. Document-Level Publishing

• Manage document publishing activities for clinical and regulatory submissions.
• Ensure documents are publication-ready and compliant with electronic submission requirements.
• Oversee quality checks, hyperlink validation, bookmark creation, and document finalization.
• Coordinate publishing timelines with cross-functional stakeholders.

4. CSR Coordination

• Coordinate Clinical Study Report (CSR) document development with relevant stakeholders.
• Collaborate with medical writers, statisticians, clinical operations, and regulatory teams.
• Track CSR milestones and ensure timely completion of deliverables.
• Facilitate issue resolution and stakeholder communication throughout the CSR lifecycle.

5. ISI Toolbox Management

• Provide oversight and subject matter expertise for ISI Toolbox processes and workflows.
• Ensure effective utilization of ISI Toolbox for document preparation and publishing activities.
• Support troubleshooting, user guidance, and best practice implementation.
• Coordinate system enhancements, validation activities, and user training where required.

6. Quality & Compliance

• Ensure adherence to SOPs, regulatory guidelines, and quality standards.
• Support audits, inspections, and compliance assessments.
• Investigate quality issues and implement corrective and preventive actions (CAPA).
• Maintain documentation and metrics related to quality, productivity, and compliance.

7. Stakeholder Management

• Act as the primary point of contact for clients and internal stakeholders.
• Provide project status updates and risk assessments.
• Build strong relationships with cross-functional teams to ensure seamless project delivery.
• Support business development initiatives and operational planning.

Required Qualifications

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, or a related field.
• Extensive experience in clinical document management, formatting, publishing, or regulatory operations.
• Strong knowledge of Clinical Study Reports (CSR), submission-ready documents, and document publishing processes.
• Experience with ISI Toolbox, Microsoft Word advanced formatting, Adobe Acrobat, and document management systems.
• Proven leadership and people management experience.
• Excellent communication, project management, and stakeholder management skills.

Why join Genpact?

• Be a transformation leader Work at the cutting edge of AI, automation, and digital innovation
• Make an impact Drive change for global enterprises and solve business challenges that matter
• Accelerate your career Get hands-on experience, mentorship, and continuous learning opportunities
• Work with the best Join 140,000+ bold thinkers and problem-solvers who push boundaries every day
• Thrive in a values-driven culture Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress
• Come join the tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up.
• Lets build tomorrow together.

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation. Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.