Principal Medical Writer, FSP
Share
Job Location:
Durham, NC - USA
Monthly Salary:
$ 84400 - 211100
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
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 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 clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is proud to be an equal opportunity employer. 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. potential base pay range for this role when annualized is $84400.00 - $211100.00. 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.
Required Experience:
Staff IC
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
