A company is looking for a Principal Medical Writer to lead the development of clinical and regulatory documents.
Key Responsibilities
Lead the development of clinical study protocols, amendments, investigator?s brochures, and other supporting documents
Co-author clinical study reports (CSRs) and data summaries for regulatory submissions
Collaborate with cross-functional teams to ensure compliance with ethical and regulatory standards
Required Qualifications
Bachelor?s degree in a scientific discipline; advanced degree (MS, PhD, MD, PharmD) is a plus
A minimum of 6+ years of experience in pharmaceutical medical writing or related disciplines
Proven track record of managing clinical study protocols and regulatory submission documents
Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements
Experience with drug-drug and biologic-biologic combination products is a plus
