Principal Medical Writer

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Requirements:

• Bachelor's degree in a scientific discipline, preferably in Pharmacy, Chemistry, Biology, or related field.
• Minimum of 6+ years of experience in pharmaceutical medical writing or related fields.
• Proven track record managing clinical study protocols, amendments, and regulatory submission documents.
• Strong knowledge of global pharmaceutical regulations, including FDA, EMA, and ICH requirements.
• Excellent leadership, collaboration, communication, and interpersonal skills.
• Proficient in word processing software and document management systems.

Responsibilities:

• Lead development of clinical study protocols, amendments, investigator’s brochures, and supporting documents.
• Develop timelines for clinical documents and ensure timely completion for regulatory submissions.
• Co-author clinical study protocols and IBs with SMEs, manage review cycles, finalize documents.
• Lead the development of clinical study reports (CSRs) and data summaries, co-authoring with SMEs.
• Prepare written summaries for regulatory submission and respond to information requests from regulators.
• Support content for meetings with regulators and identify risks in submission activities.