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Principal Medical Writer

5+ years
Not Disclosed
10 July 23, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About the Job: Principal Medical Writer

Job Description:

Meet is partnering with a top 10 pharmaceutical company seeking an enthusiastic and passionate Principal Medical Writer to join their immunology team! This remote position offers the chance to contribute individually and lead the writing of clinical stage and study-level documents. The role promises a supportive culture, great leadership, and an exciting workload.

Job Responsibilities:

  • Prepare and submit regulatory and clinical stage documents, including CSRs, IBs, protocols, INDs, and submission work.
  • Provide expert support to clinical teams and effectively liaise with internal and external departments.
  • Serve as the lead author and manage timelines.

Skills Required:

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

Contact:

For more information, please contact Michelle Lieberman at michelle@peoplewithchemistry.com. All inquiries will be handled confidentially.