Intern, Medical Writing

POSTION SUMMARY

Mirum’s Summer Internship Program will provide the intern an opportunity over the course of 10-12 weeks to gain experience in regulatory medical writing with exposure across all aspects of clinical drug development.  Projects will have clear deliverables and opportunities to engage with executive management.  Summer interns will get a chance to learn from the experienced functional team members who support our drug development efforts.

ROLES & RESPONSIBILITIES

• Medical Writing (MW) i.e., preparation of clinical and regulatory documents in a team environment
• Gaining familiarity with the scope of work of the MW group and of the key clinical documents used in clinical studies
• Gaining familiarity with MW Style Guide, key ICH guidance documents (e.g., E3, E6), and electronic common technical document (eCTD) conventions
• Shadowing QC of clinical study documents such as protocol amendments, clinical study reports (CSRs), and Investigator Brochure (IB) updates
• Shadowing the development of CSR safety narratives and assisting with their QC
• Shadowing the process for developing and reviewing clinical study documents
• Reorganizing the MW group’s literature references
• Reviewing MW SharePoint folder for ease of use, clarity, consistency, nomenclature etc.

QUALIFICATIONS

Work Opportunity:

• Paid summer internship
• Be authorized to work in the United States
• Be able to complete a 10-12 consecutive week (40 hours/week) internship between May and August
• Be able to relocate and work at the Foster City, CA site for the duration of the internship (Mirum is not covering the cost of housing)

Education/Experience:

• Graduate-level student in life sciences ready to dive into meaningful projects
• Strong interest and/or experience in biotech/pharma
• In-depth skills with Microsoft Office (Word, Excel etc.)
• Experience with SharePoint or similar desirable

Knowledge, Skills and Abilities:

• Genuine interest in healthcare and patient-focused work
• Excellent written and oral communication skills
• Strong analytics and problem solving
• Thrives in ambiguity
• Team orientated and ability to work collaboratively

Please include your cover letter with reasons why you are a good fit for this job.

#LI-ONSITE