Senior Manager, Medical Writing Services
WFA Digital Insight
The demand for skilled medical writing professionals has grown significantly, with a 25% increase in job openings in the past year. Parexel, a leading provider of medical writing services, is now hiring a Senior Manager to lead their team in India. As the pharmaceutical industry continues to evolve, professionals with expertise in signal management, aggregate reporting, and team leadership are in high demand. With the global pharmacovigilance market projected to reach
Job Description
About the Role
The Senior Manager, Medical Writing Services will play a critical role in leading the medical writing team at Parexel. This role entails overseeing end-to-end signal management activities, including detection, validation, evaluation, tracking, and closure. The successful candidate will also be responsible for managing teams, driving operational excellence, and ensuring compliance with global pharmacovigilance regulations and client-specific processes.As a Senior Manager, you will be responsible for guiding the development of Corporate Social Responsibility (CSR) narratives and safety assessments, ensuring scientific rigor and regulatory compliance. You will also oversee the delivery of signal management and aggregate writing programs, managing timelines, resources, budgets, and risks to ensure high-quality, on-time delivery.
Parexel is a leading provider of medical writing services, and this role offers the opportunity to work with a talented team of professionals who are passionate about improving the world's health. The company values collaboration, accountability, and continuous improvement, and the successful candidate will be expected to embody these values in their work.
What You Will Do
- Lead end-to-end signal management activities, including detection, validation, evaluation, tracking, and closure
- Perform and oversee qualitative and quantitative signal analysis across clinical, post-marketing, literature, and regulatory data sources
- Ensure compliance with global pharmacovigilance regulations and client-specific processes
- Provide oversight and/or author aggregate safety reports, including Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), and allied documents
- Guide development of Corporate Social Responsibility (CSR) narratives and safety assessments, ensuring scientific rigor and regulatory compliance
- Oversee delivery across signal management and aggregate writing programs
- Manage timelines, resources, budgets, and risks to ensure high-quality, on-time delivery
- Drive operational excellence, efficiency, and continuous process improvement
- Provide overall leadership and strategic direction to teams, ensuring alignment with organizational goals and client expectations
- Oversee end-to-end delivery, ensuring quality, timeliness, and efficiency across projects
- Manage resource planning, workload distribution, and budget considerations to optimize productivity
What We Are Looking For
- Bachelor's degree in a life science or related field
- At least 8 years of experience in medical writing, pharmacovigilance, or a related field
- Proven experience in leading teams and managing projects
- Strong knowledge of global pharmacovigilance regulations and client-specific processes
- Excellent leadership and communication skills
- Ability to work in a fast-paced environment and prioritize multiple tasks
- Strong analytical and problem-solving skills
- Experience with signal management and aggregate reporting
- Familiarity with regulatory requirements and industry trends
Nice to Have
- Experience with Adjust and Excel
- Certification in medical writing or a related field
- Experience working with cross-functional teams
Benefits and Perks
- Competitive salary and benefits package
- Opportunity to work with a leading provider of medical writing services
- Collaborative and dynamic work environment
- Professional development opportunities
- Flexible working hours and remote work options
- Access to cutting-edge technology and tools
- Recognition and reward for outstanding performance
How to Stand Out
- Develop a strong understanding of global pharmacovigilance regulations and client-specific processes to stand out in this role.
- Highlight your experience with signal management and aggregate reporting in your application.
- Showcase your leadership and communication skills, and provide examples of how you have successfully managed teams and projects.
- Familiarize yourself with industry trends and regulatory requirements to demonstrate your expertise.
- Prepare to discuss your experience with Adjust and Excel, and be ready to provide examples of how you have used these tools in your work.
- Be prepared to talk about your approach to driving operational excellence and continuous process improvement.
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