Senior Manager, Medical Writing Services

Job description

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 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 provide input into regular review of these documents, as applicable. Also be familiar with non-MWS SOPs that impact work. Analyze efficiency of work: collect and evaluate metrics to identify need for improvement efforts in processes, staff educational activities, or to better meet client needs. Discuss improvement ideas with colleagues within and outside of MWS. Provide guidance to other members of the department on current medical writing issues and acceptable procedures. Attend external audits as required; respond to audit reports and follow-up on any issues highlighted. Maintain ultimate responsibility for Medical Writing aspects of assigned projects, without supervision. Author Clinical Documents/ Consultancy In line with client requirements, gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize any type of medical writing deliverable without the need for any supervision or formal training, including those for which little or no regulatory or other guidance is available. Advise on medical writing regulatory issues and submissions, as detailed in current ICH, FDA, EMA, and other applicable guidelines. Quality Control Strive to ensure internal and external clients receive a quality product on time, all of the time. Ensure projects assigned to line reports are completed with quality, according to SOPs, and on time. Provide technical leadership to ensure clinical data presented in summary documents are in compliance with applicable regulatory guidelines, SOPs, and goals of submission Training/ Compliance Keep abreast of new advances in medical writing, regulatory updates, and industry trends. Develop training materials and present to MWS staff to enhance writing quality, efficiency, and project management. Present details of training courses attended or new knowledge acquired. Provide training and be a mentor for less experienced MWS members. Produce training material for and present external training courses. General Participate as member or leader of departmental committees (e.g., process improvement, standards, partnerships). Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner. Provide short-term ‘basic’ coverage in the absence of other MWS management. Perform other tasks appropriate to a more senior position as required, with adequate support and under supervision. Other roles may be allocated in exceptional circumstances. Promote the medical writing profession, internally or externally. Skills : 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. Knowledge and Experience : 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. Education : Bachelor's degree or higher in Life Sciences/Health Related Sciences or equivalent.