Senior Manager, Medical Writing Services Hyderabad (India)

Senior Manager, Medical Writing Services Hyderabad (India)

17 Aug
|
Parexel
|
India

17 Aug

Parexel

India

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From
clinical trials to regulatory, consulting, and market access, every clinical
development solution we provide is underpinned by something special - a deep
conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a
therapy that ultimately will benefit a patient. We take our work personally, we
do it with empathy and we're committed to making a difference.
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 (Periodic
Advantage-Risk Evaluation Report (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
Ensure effective integration of signal outputs into aggregate reporting and
risk management strategies
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

Managerial Responsibilities
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
Drive performance management, coaching, and d

📌 Senior Manager, Medical Writing Services Hyderabad (India)
🏢 Parexel
📍 India

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