Senior Manager, Medical Writing Services

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Medical Writing Services based in India.

This leadership role sits at the core of global clinical development and regulatory documentation, overseeing high-impact medical writing and signal management activities that support safe and effective therapies. You will lead cross-functional teams responsible for generating critical regulatory and safety documents used throughout the drug development lifecycle. The role combines strategic oversight with hands-on scientific and operational leadership, ensuring quality, compliance, and consistency across deliverables. You will work closely with clients, regulatory stakeholders, and internal teams to shape evidence-based narratives and ensure regulatory alignment across global submissions. In addition to delivery oversight, you will drive process improvements, operational excellence, and resource optimization across multiple programs. This is a highly influential position where your leadership directly supports the development of life-changing treatments for patients worldwide. The environment is fast-paced, collaborative, and deeply mission-driven.

• Lead end-to-end signal management activities including detection, validation, evaluation, tracking, and closure across clinical and post-marketing data sources.
• Oversee qualitative and quantitative signal analysis and ensure integration into aggregate safety reporting and risk management strategies.
• Author and/or review key regulatory and safety documents such as PBRERs, DSURs, RMPs, CSR narratives, and related submissions.
• Ensure compliance with global pharmacovigilance regulations, internal SOPs, and client-specific requirements across all deliverables.
• Provide strategic leadership for medical writing teams, ensuring quality, consistency, and timely delivery of outputs.
• Manage project timelines, budgets, resources, and risks to ensure efficient execution of multiple concurrent programs.
• Act as key escalation point for project, client, and team-related issues, ensuring timely resolution and stakeholder alignment.
• Lead client engagement activities, including proposal development, scope assessment, and presentation of medical writing capabilities.
• Oversee line management responsibilities including hiring, coaching, performance reviews, and professional development of team members.
• Drive operational excellence through KPI tracking, process improvement initiatives, and implementation of best practices.
• Ensure quality control across all medical writing deliverables in compliance with regulatory expectations and internal standards.
• Contribute to business growth by identifying opportunities, supporting proposals, and strengthening client relationships.

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Requirements:

• Bachelor’s or Master’s degree in Life Sciences, Health Sciences, or a related field.
• Extensive experience in medical writing within clinical research and drug development environments.
• Strong background in managing complex medical writing projects and global regulatory deliverables.
• Proven leadership experience, including team management, mentoring, and performance oversight in a billable services environment.
• Deep understanding of pharmacovigilance, clinical documentation, and regulatory guidelines (ICH, FDA, EMA).
• Strong project management skills, including planning, monitoring, budgeting, and resource allocation.
• Experience working in matrixed, global, and client-facing environments.
• Excellent written and verbal communication skills with strong stakeholder management ability.
• Strong analytical thinking, problem-solving, and decision-making skills under pressure.
• Ability to manage multiple priorities in a fast-paced, deadline-driven environment.
• Proficiency in Microsoft Office and familiarity with document management and collaboration systems (e.g., SharePoint).
• Fluent in English, with willingness to travel as required.

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Benefits:

• Competitive salary aligned with experience and global industry standards
• Performance-based incentives
• Opportunity to lead global medical writing and pharmacovigilance programs
• Exposure to international regulatory submissions and clinical development projects
• Leadership role with significant team management responsibility
• Continuous learning and professional development opportunities
• Collaborative, science-driven, and mission-focused work environment
• Opportunity to contribute directly to therapies that improve patient outcomes worldwide