Manager, Lab Quality

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.
• Acts as a positive role model to staff in attitude to, and dealings with, colleagues and customers.
• Experienced and effective in providing feedback and guidance to staff.
• Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with direct reports, colleagues, and customers.
• Confidence in appropriately challenging the customer when document quality or timelines are at risk.
• Demonstrates financial awareness, promotes good practices to manage costs.
• Confident in raising and discussing sensitive topics without management intervention.
• Demonstrated ability to remain calm and assertive yet diplomatic in more challenging interactions with customers and colleagues.
• Ability to establish and maintain effective working relationships with coworkers, direct reports, managers, and customers, at a senior level.
• Demonstrated abilities in collaboration with others and independent thought.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Excellent attention to detail and accuracy.
• Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges.
• Demonstrates good judgement in requesting input from senior staff.
• Ability to effectively manage multiple tasks and projects. Decisive amongst competing priorities.
• Must be computer literate.

Q² Solutions,IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. q2-solutions-eoe

Q² Solutions’ ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding COVID-19 vaccination status.q2-solutions-covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $95,100.00 - $142,700.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.