We are seeking Medical Writer to join IQVIA Laboratories at Indianapolis, IN.

We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development.

As a Lead Medical Writer, you will prepare assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements, ensuring adherence to agreed timelines. You will also negotiate timelines and resolve customer comments with senior support as needed.

What you’ll be doing:

• Take a leading role in preparing assigned documents, including confirming the scope of the task, templates, and specifications.
• Negotiate and adhere to timelines, organize document reviews, and communicate directly with the customer.
• Manage day-to-day workload: identify project needs, track timelines, and implement customer requests.
• Keep manager/senior staff updated on progress and any potential issues with project work.
• Attend project team meetings and participate in/lead comments resolution meetings with external customers.
• Give simple presentations to existing customers (e.g., on processes at a Kick-off meeting).
• Complete project finance activities, including monitoring and forecasting budgeted hours.
• Develop an awareness of budgets and project finance principles, moving towards understanding budgets related to assigned projects, including out-of-scope activities.

What we are looking for:

• Bachelor’s Degree in life sciences related discipline or related field (Required).
• Master’s Degree in life sciences related discipline or related field (Preferred).
• Ph.D. in life sciences related discipline or related field (Preferred).
• Typically requires 1-3 years of prior relevant experience and related competency levels (Required).
• Familiarity with the structural and content requirements of clinical study reports, protocols, and similar 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 identify deficiencies, errors, and inconsistencies in statistical output (Preferred).
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner (Required).

The knowledge, skills, and abilities needed for this role:

• In-depth knowledge of drug development, medical writing, and associated regulations.
• Good understanding of statistical principles and medical terminology across a range of therapeutic areas.
• Excellent written and oral communication skills, including grammatical/technical writing skills.
• Excellent attention to detail and accuracy.
• Ability to communicate clearly, effectively, and confidently with others.
• Demonstrated abilities in collaboration with others and independent thought.
• Demonstrates confidence and maturity in most routine medical writing situations.
• Demonstrates good judgment in requesting input from senior staff.
• Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
• Ability to effectively manage multiple tasks and projects.
• Must be computer literate.

What we offer you:

We put our employees at the center of everything we do and are committed to providing them, and their families, with benefits that meet their diverse and changing needs. We invest in integrated benefits programs and resources to take care of our employees’ physical, mental, emotional, financial, and social well-being so they can thrive at home and at work, at any stage of their well-being journey.

To learn more about our benefits, visit https://jobs.iqvia.com/benefits.

If you’re looking to unleash your potential, join IQVIA Laboratories to help make the extraordinary possible!

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. https://jobs.iqvia.com/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. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $58,800.00 - $98,000.00. 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.