Medical Writing Intern
This is what you will do:
The primary purpose of this internship will be to provide an opportunity to learn about the role of the medical writer within the pharmaceutical industry by becoming familiar with the suite of documentation supporting clinical development. This role will provide writing, editorial, and QC quality checks for clinical study documents for Alexion clinical development programs. The medical writing intern will be accountable for ensuring that deliverables are in line with Alexion’s authoring and QC standards and checklists. The intern will work with one or more experienced medical writers on projects to support clinical studies and have the opportunity to be exposed to the drug development process.This role may support internal medical writing process improvement or template updates.
Specifically, we are seeking individuals with the traits listed below:
- Motivated self-starter who is detailed, results and process oriented with a focus on effective and efficient improvements
- Organized individual with the ability to manage multiple priorities while maintaining high performance standards
- Superior problem solving and analytical skills and ability to work in a highly visible, deadline-oriented position and environment
- Strong communication and people skills, comfortable working with a cross functional and collaborative team and effectively able to deal with all levels of personnel
You will be responsible for:
- Performing accurate and precise editing and/or proofreading to include spelling, grammar, punctuation, and verification of data of clinical documents (eg, study reports, Investigator's Brochures, protocols, and protocol amendments).
- Ensuring quality and timeliness of reviewing and editing of clinical documents.
- Verifying content and numerical accuracy (100% review) of all factual statements and data cited throughout document compared to sources cited (when appropriate).
- Ensuring adherence to Alexion document templates and Style Guide.
- Developing and providing factual evidence to support all discrepant findings for review and approval by document authors.
- Working collaboratively with Alexion RDU Medical Writing and cross‑functional teams to continuously improve processes.
- Attending and participating in Medical Writing and project team meetings.
- Providing an end of internship summary presentation.
You will need to have:
- Experience with various MS Office programs, including Word, Excel, Outlook, Visio, Project, and PowerPoint
- The ability to fluently read, write, understand, and communicate in English
- Ability to understand and interpret complex clinical and/or scientific and statistical data and effectively communicate inaccuracies in technical documents to authors.
- Ability to conduct thorough and accurate research (eg, literature reviews), have logical organizational skills and clear readable writing.
- Ability/desire to learn new techniques and best practices
- Good interpersonal, collaborative and communication skills
- Attention to detail – a must
- A successful candidate would typically have a BS / MS in English/ Life sciences and currently enrolled in a MS or PhD program. Upper-class-persons who have not yet received their BS/BA and are enrolled in a program listed above may also be considered.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
- Previous experience in clinical/technical writing of clinical technical document deliverables
- Experience in clinical research or working with clinical regulatory documents preferred, but not required