Senior Manager, Medical Writing Services
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 development of team members
- Ensure adherence to organizational policies, SOPs, and regulatory requirements
- Act as a key escalation point for project, team, and client-related issues, ensuring timely resolution
- Foster a culture of collaboration, accountability, and continuous improvement
- Support business growth initiatives, including client engagement, proposals, and scope expansion
- Identify and implement process improvements and operational efficiencies
- Facilitate effective cross-functional collaboration and stakeholder alignment
Key Accountabilities :
Line and General Management
- Supervise and mentor line reports, including all aspects of MWS personnel management: hiring, training, professional development, periodic/annual performance evaluations, compensation recommendations, promotions, team building, morale, motivation, and supervision of adherence to departmental procedures and health authority guidance and regulations.
- Validate quality and training compliance.
- Ensure appropriate billable time for line reports.
- Undertake the full range of duties relevant to performance management of line reports:
- Situational leadership, including delegation, empowerment, and accountability.
- Influence and guidance to ensure their performance meets or exceeds both the business and their own personal goals/objectives.
- Retain good employees; identify talent and nurture employees to ensurethe organization has strong bench strength to compete at the highest levels.
- Manage low performance through coaching and training; execute performance improvement plans or termination, as required.
- Attend manager meetings, and chair as invited.
- Sign off expenses/invoices/purchase orders for expenses, as authorized by MWS management.
Client Liaison/Service
- Be aware of client expectations for self and team members/line reports.
- Build and maintain collaborative client relationships, to cultivate efficient, productiv