Senior Scientific Writer - BioA Large Molecule (US Remote)

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. 

Responsibilities

• 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.
• Manage day-to-day workload: identify project needs, track timelines and implement customer requests, keeping manager/senior staff abreast of progress on tasks and any potential problems with project work.
• Lead customer meetings independently.
• May give presentation to an existing customer (e.g. to discuss templates, results, lessons learned), responding appropriately to feedback.
• May deliver basic level training to small groups or individuals on the role of the medical writer, on medical writing processes, or on specific customer templates/processes. May also provide guidance to more junior colleagues.
• May take the role of Project Manager for a small and short Medical Writing project.
• Complete project finance activities, including monitoring and forecasting budgeted hours.
• Understand budgets and project finance principles. Interact with Project Leader/Project Finance Manager directly regarding straightforward financial issues, increasing ability to estimate hours needed for more straightforward/routine tasks.
• May propose revisions to standard operating procedures (SOPs) or suggest process improvements for consideration.

Minimum required education and experience

• 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 at least 3 years of prior relevant experience and related competency levels.

Required knowledge, skills and abilities

• Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents.
• Ability to identify deficiencies, errors, and inconsistencies in a protocol or report.
• Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.
• Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output.
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
• Significant experience as a lead writer in preparing CSRs and protocols, with consistently positive feedback from customers and colleagues.
• 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.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Excellent attention to detail and accuracy.
• Communicates 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 judgement 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.
• Ability to proactively identify potential issues/risks, consider solutions, and raise with the customer, with senior guidance and input.
• Must be computer literate.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.