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.
- Prepares or contributes to the preparation of clinical documents, for either internal customers or external clients, for investigational drugs, biologicals, or medical devices.
- Collaborates with internal experts and specialists; conducts thorough research; maintains expertise on developments in a particular field of focus.
- Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents.
- Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
Minimum required education and experience
- A Bachelor’s degree in a life science-related discipline, communications, technical writing, or related field, advance degree preferred, with at least 1 year of experience in a medical, clinical, preclinical, chemistry or related environment; or equivalent combination of education, training and experience.
Required knowledge, skills and abilities
- Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.
- Good understanding of common statistical methods used in clinical trials and interpretation of their results.
- Ability to give a presentation to a project team and/or customer on project-specific topics, e.g. on lessons learned.
- Ability to identify deficiencies, errors, and inconsistencies in regulatory documents.
- Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output.
- Can provide thorough, appropriate, and sensitive feedback to peers upon request to review a document.
- Ability to work on several projects at once while balancing multiple and overlapping timelines.
- Ability to assess workload and suggest a prioritization strategy to senior staff.
- Demonstrated abilities in collaboration with others and independent thought.
- Knowledge of regulations relevant to medical writing, such as Good Clinical Practices (GCP) and other relevant guidances (e.g., ICH).
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Confidence in building relationship with customer and discussing medical writing issues with customers in person, via e-mail or on the telephone.
- Careful attention to detail and accuracy.
- 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 [email protected] to arrange for such an accommodation.