Senior Manager, Medical Writing Services

Job description

- 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 ensure the 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 experience - Understand the challenges clients face in getting therapies to market and propose solutions on how to overcome such challenges. - Use awareness of opportunities in the industry to present new possibilities to customers, when appropriate. **Project Management** - As applicable, manage individual, partner, stakeholder, and customer relationships and their performance; manage partnership operations, relationships, and personnel. - Set clear objectives for assigned Medical Writing team members/line reports and continuously monitor performance against these objectives. - Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks. Monitor progress of each individual project task and assess the overall program. - Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget. - Keep client and team informed of project status. - Provide project updates to MWS management, and assess forecasting and resourcing. Propose creative solutions for shifting timelines and staffing requirements to MWS management. - Contribute to process development/improvement: - Oversee efficient budgeting and support financial monitoring to maximize profitability of assigned projects. Ensure appropriate changes in scope are escalated. - Be familiar with all MWS department Standard Operating Procedures (SOPs) and guidelines, and p