Manager, Medical Writing

JOB OVERVIEW

Manages a group of medical writers and takes responsibility for individual development and group performance. Monitors quality and financial performance of the group and participates in the selection process for new staff. Manages routine workload of the group, liaising with other managers, and supports Global Medical Writing goals and initiatives. Performs senior review of all types of medical writing deliverables and provides feedback and guidance to staff. Supports direct reports as needed in managing customer interactions and communications. May act as Lead Medical Writer on any type of writing project.

Keeps abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practices (GCP), along with developments and advances in drug development/medical and/or technical writing.

RESPONSIBILITIES

• Manage performance of direct reports: set goals and objectives, perform appraisals, and propose ratings, propose promotions and bonus, merit, and promotional increases, monitor utilization and workload and act, accordingly, assign tasks to maximize utilization while considering development.
• Identify training needs and create training plans for direct reports to ensure swift onboarding and development. Liaise with senior writers to provide support and opportunities for direct reports. May propose, plan, and deliver training on Medical Writing to other IQVIA groups and externally, as appropriate. Take appropriate action to address development needs or performance issues with direct reports.
• Monitor the financial performance of group/direct reports. Monitor and proactively follow-up on backlog, change orders, revenue recognition for direct reports' projects. Independently propose, review, and approve budgets and assumptions for a range of project types within remit.
• May have initial contact with customers on new projects, before a writer is assigned, or to support a direct report.
• Chair meetings and resolve conflict.
• Can use experience and initiative to tackle and advise others on new/unusual document types and customer requirements.
• Participate in bid defense meetings and discussions.
• May take on a partnership lead role.
• May take a project management role for projects involving Medical Writing.
• Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, communicating directly with the customer, and monitoring and forecasting project budgets.
• Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests.

MINIMUM EDUCATION REQUIRED AND EXPERIENCE

• Bachelor's Degree bachelor’s degree in life sciences related discipline or related field Required.
• Master's Degree master’s degree in life sciences related discipline or related field Preferred.
• Ph.D. Ph.D. in life sciences related discipline or related field Preferred.
• Typically requires at least 7 years of highly relevant experience and related competency levels. Required

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Experienced in line management, including setting goals and objectives for direct reports. Preferred
• Experienced in budgeting medical writing deliverables and defining scope of work. Required
• In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in documents. Required
• Good understanding of common statistical methods used in clinical trials and/or interpretation of their results. Required
• Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output. Required
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner. Required
• Extensive experience in preparing CSRs and protocols independently to a consistently high standard, regardless of complexity or challenges. Required
• Experienced in preparing CTDs and/or tackling new/unusual document types/customer requirements. Preferred
• In depth knowledge of drug development, medical writing, and associated regulations. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas. Required
• Ability to clearly and positively communicate medical writing and IQVIA global and regional objectives and present to direct reports in a well-informed way.
• Ability to listen to, respond appropriately, and act upon input and/or feedback and/or concerns from direct reports or others.