Medical Writer 1

IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

**Job Overview**
Join our team as a skilled Regulatory Medical Writer I and play a critical role in producing straightforward projects with precision and efficiency. As a valued member of our team, you will create documents that adhere to IQVIA's Standard Operating Procedures, customer requirements, and project timelines. You will have the opportunity to negotiate timelines and address customer comments with the support of senior team members.

Stay at the forefront of the industry by continuously updating your medical and technical writing knowledge, including GCP, and being aware of the latest developments in drug development and medical writing. With this role, you'll have the chance to make a meaningful impact and grow your expertise in the field.

**Essential Functions**
- 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.
- Attend project team meetings with or without other writers. Participate in/lead comments resolution or similar meetings with external customers.
- May give simple presentation to an existing customer (e.g. on processes at a Kick-off meeting).
- Complete project finance activities, including monitoring and forecasting budgeted hours.
- Awareness of budgets and project finance principles, moving towards review and understanding of budgets relating to assigned projects, including out of scope activities.

**Qualifications**
- Bachelor's Degree Bachelor's Degree in life sciences related discipline or related field Req
- Typically requires 1-2 years of prior relevant experience as a Regulatory Medicla writer and related competency levels. Req
- Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents.

Req
- Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.

Req
- Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output Pref
- Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner. Req
- 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. Req
- 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.
- Must be computer literate.