Job Overview:
As a Lead Medical Writer on most types of writing projects. You will prepare assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Perform Senior Review of straightforward medical writing deliverables. Negotiate timelines and discusses/resolves customer comments. Provide written and verbal feedback to junior staff, and to customers when appropriate. Keep abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing.
Responsibilities:
Writes clear and concise clinical submission documents, including clinical study reports, protocols, clinical overviews, investigator brochures, and summary documents; experience with late-stage health authority responses is a plus.
Contributes to project plan concerning timelines as well as organization and table layout for a specific document.
Ensures that documents meet regulations, and the key messages as defined by the team are clearly and adequately represented.
Review and edit documents for consistency, progression, structure, and grammar.
Review statistical analysis plans and incorporate into clinical study reports or submission documents, as applicable.
Drive the document preparation process, manage timelines, receive, and review primary statistical output, draft, and distribute document for review, compile comments and edits, lead comment resolution meetings independently.
Participate in team and client meetings as requested. Deliverables above plus able to work independently on a range of complex clinical documents
Interprets, summarizes, and presents statistical and medical information to ensure accuracy of content in highly complex document types independently
Resolves complex problems independently
Education and Experience required:
8+ years of experience in medical writing or related field
Required - Bachelors Degree in Life Sciences or related field
Preferred - Masters or PhD in Life Sciences or related field
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
The potential base pay range for this role, when annualized, is $124,400.00 - $211,900.00. 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.
