Senior Manager, Medical Writing Services (Hyderabad)

Senior Manager, Medical Writing Services (Hyderabad)

16 Aug
|
Parexel
|
Hyderabad

16 Aug

Parexel

Hyderabad

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
Benefit-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)
🏢 Parexel
📍 Hyderabad

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