Senior Manager, Medical Writing Services
New
IndiaFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- English
- Required Skills
- Project ManagementSharePoint
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.
- Strong background in managing complex medical writing projects and global regulatory deliverables.
- Proven leadership experience in a billable services environment.
- Deep understanding of pharmacovigilance and clinical documentation.
- Expertise in regulatory guidelines such as ICH, FDA, and EMA.
- Strong project management skills including planning, monitoring, and budgeting.
- Experience working in matrixed, global, and client-facing environments.
- Fluent in English.
- Proficiency in Microsoft Office and document management systems like SharePoint.
- Willingness to travel as required.
Responsibilities
- Lead end-to-end signal management activities including detection, validation, evaluation, tracking, and closure.
- Oversee signal analysis and integration into aggregate safety reporting and risk management strategies.
- Author and review key regulatory documents such as PBRERs, DSURs, RMPs, and CSR narratives.
- Ensure compliance with global pharmacovigilance regulations, SOPs, and client requirements.
- Provide strategic leadership, project management, and resource allocation for medical writing teams.
- Act as the key escalation point for project, client, and team-related issues.
- Manage client engagement, including proposal development and scope assessment.
- Oversee line management responsibilities including coaching and professional development.
- Drive operational excellence through KPI tracking and process improvement.
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