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Regulatory Associate - Medical Writing

1+ years
Not Disclosed
10 Jan. 8, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

Title: Regulatory Associate - Medical Writing

Location: [Insert Location]

Job Summary:
We are seeking an experienced Medical Writer with expertise in CTD medical writing and clinical development of medicines. The ideal candidate will contribute to the preparation of high-quality regulatory documents and assist in drug development strategies.

Key Responsibilities:

  • Write high-quality CTD modules, including nonclinical and clinical overviews & summaries (Module 2.5, 2.4, 2.7, 2.7) in accordance with EU submission requirements.
  • Address clinical deficiencies in response documents.
  • Assist with the development of drug strategies.
  • Update SmPC, Patient Information Leaflet, CCDS, and handle safety variations.
  • Write clinical study reports, design studies, and create synopses.
  • Review study reports and published papers related to clinical development.
  • Conduct literature searches and regulatory evaluations.
  • Support Rx to OTC evaluations.
  • Contribute to PSURs, PADER, and RMP submissions.

Qualifications:

  • MBBS in Medicine, M.Pharma in Pharmacy, Medical-MS/MD in Pharmacology, Ph.D., or Doctorate in Pharmacy.
  • Proven experience in medical writing for regulatory submissions in Europe.
  • Expertise in CTD modules (2.5, 2.4), clinical pharmacology, PSUR, and regulatory submissions.
  • Strong scientific writing skills and attention to detail.
  • In-depth understanding of Generic, Hybrid, and New drug applications.
  • Experience with clinical study design and protocol.
  • Excellent communication and time management skills.
  • Specialization in Pharmacology is preferred.