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, productive, and professional working relationships that promote satisfaction and confidence. Implement quantitative measures of performance (key performance indicators) into feedback, metrics, and continuous improvement activities to optimize performance in a data-driven manner. Respond appropriately to incidents of dissatisfaction and provide feedback to MWS management. In the proposal generation process, provide strategic and project planning intelligence to MWS management for standalone through full-service medical writing activities. Provide an assessment of scope of services for clients with respect to medical writing tasks, including a description of the medical writing services to be performed and estimated hours for each task. Liaise with the proposal team and/or client to ensure that the proposal covers all services required. If called upon, attend business development and proposal meetings to prepare and present to clients. Provide support as appropriate to Business Development/Client Solutions in their efforts to win new business. Identify and solicit new business leads for MWS. Apply industry experien