Principal Medical Writer

Principal Medical Writer

Job Description:

Meet's partnered with a top 10 pharma who is looking for an enthusiastic and passionate Principal Medical Writer to join their immunology team! This role will be responsible for individually contributing to and leading the writing of clinical stage/study level documents. This is an incredible remote opportunity for someone who values great leadership, supportive culture and an exciting workload!

Job Responsibilities:

• Contribute to the preparation and submission of regulatory and clinical stage documents (CSRs, IBs, protocols, INDs and submission work)
• Provide expert support to clinical teams and liaise with internal and external departments effectively
• Serve as lead author and help manage timelines

Skills Required:

• Advanced science degree preferred; Bachelor’s degree required
• 5+ years of experience in regulatory writing; prior experience in a pharmaceutical environment preferred
• Knowledge of FDA/international regulations and ICH guidelines
• Excellent communication, leadership, and problem-solving skills

Contact

Please contact Michelle Lieberman at michelle@peoplewithchemistry.com if you would like to know more about this opportunity. This will be 100% confidential.