Associate Medical Writer
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Job Overview
Within a structured program supports Medical Writing deliverables and focuses on specific tasks under senior supervision while gaining experience knowledge and skills in Medical Writing. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines.
Keeps 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.
Essential Functions
Consolidate and expand knowledge experience and competence in specific Medical Writing tasks by preparing assigned documents to a high standard with growing independence focusing on tasks such as writing patient narratives.
Manage day-to-day workload track timelines draft assigned documents to a high standard and implement review comments and customer requests with senior guidance/review keeping manager/senior staff abreast of progress on tasks and any potential problems.
Interact with internal clients. May have some external interactions mostly directed by senior staff.
Keep abreast of current data trends medical and/or technical writing/regulatory knowledge developments and advances in area of drug development/medical and/or technical writing.
Comply with customer requirements and with IQVIA Standard Operating Procedures (SOPs) and standards.
Qualifications
Bachelors Degree Bachelors Degree in life sciences related discipline or related field Req
Masters Degree Masters Degree in life sciences related discipline or related field
Pref
Ph.D. Ph.D. in life sciences related discipline or related field Pref
Typically requires completion of at least 1 year as a Medical Writing Trainee within the program with a high level of performance including significant experience in preparing CSR narratives to a high standard and with decreasing levels of guidance. Req
Good knowledge of drug development medical writing and associated regulations and in particular the requirements and standards for patient narratives. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas. Req
Excellent written and oral communication skills including grammatical/technical writing skills.
Familiarity with the structural and content requirements of clinical study reports protocols and similar documents.
Clear understanding of the purpose and requirements of different types of narratives and the sources of their content.
Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.
Ability to integrate interpret and summarize data from a variety of sources in a clear and concise manner.
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.
Must be computer literate.
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
Required Experience:
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
