Senior Manager, Medical Writing

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
• 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

Qualifications

Highest qualification: University

• Excellent interpersonal, negotiation, verbal and written communication skills.
• A professional and flexible attitude with respect to work assignments and new learning.
• Motivation to work independently and consistently in a fast-paced, rapidly changing environment.
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.
• Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills, cross-cultural sensitivity and can influence without authority.
• Exhibits logical thinking and sound judgement. Escalates issues to departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved.
• Demonstrates a client-focused approach to work. Establishes a connection with the client, to gain repeat business and/or to widen existing scope and services.
• Ability to gain trust and confidence within the company.
• Ability to act with confidence during demanding situations in the face of opposition, challenge, or anxiety.
• Provides departmental expertise and perspectives to promote prospective business opportunities; provides Parexel colleagues with pertinent information to formalize a sound business strategy.
• Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations.
• Broad experience in management of complex medical writing projects.
• Understanding of people management: previous line management experience, or equivalent, preferably in a billable service industry.
• Project management experience (e.g., planning and monitoring).
• Business awareness/business development experience.
• Knowledge of resource management and productivity metric management.
• Advanced word processing skills, including Microsoft (MS) Office (expertise in Word and competency in Excel); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (e.g., MS Access).
• Ability to travel.
• Fluent in written and spoken English.
  
  
• Bachelor's degree or higher in Life Sciences/Health Related Sciences or equivalent.