Medical Writing Intern

Job Description

The Medical Writing Intern (MWI) assists with medical writing activities in support of the GCDO – Medical Writing & Transparency department at a Biopharmaceutical Company. The MWI works closely with MW personnel to develop regulatory documents in support of company products. This individual will work to assigned timelines, communicate effectively to the responsible medical writer, and ensure their deliverables are completed according to appropriate quality standards. 

Job Responsibilities

• Assist in writing and reviewing regulatory documents (eg, investigator’s brochures, participant narratives, clinical study protocols and reports) 

• Ensure that documents comply with International Conference on Harmonization guidelines, SOPs, and Good Clinical Practices

• Assist the responsible medical writer with managing document timelines 

• Participate in department and/or clinical trial team meetings and collaborative efforts (eg, department initiatives)

Education & Qualifications

• Strong written and oral communication skills 

• Strong organization and time management skills and attention to detail

• An understanding of the clinical development process, including the documents that are required at each stage is preferred

• Exposure to Good Clinical Practices (GCP) regulations preferred

• Proficient with Word, Excel, and PowerPoint

• No industry experience required 

Required Education

• Currently enrolled in university with minimum 45 credits

• Seeking degree in the life sciences 

• Completion of college level 100 biology and chemistry courses