Remote Senior Medical Writer & Regulatory Lead

Lexicon Pharmaceuticals; Spring (TX); À distance; USD 110 000 - 170 000; Plein temps

Résumé du poste

Lexicon Pharmaceuticals is seeking a collaborative, agile Senior Medical Writer to join our team in Bridgewater, NJ, The Woodlands, TX, or remotely. The role focuses on producing accurate, compliant documents across R&D, quality and regulatory activities.

The Senior Medical Writer will coordinate cross-functional work, manage external writers, and ensure documentation aligns with Lexicon standards and timelines. A bachelor’s degree and 5+ years of medical writing experience are required.

Qualifications

• 5+ years of medical writing experience in a CRO, medical communications company, pharmaceutical company or other medical/scientific setting.
• Knowledge of the drug development and approval processes in the U.S. is required.
• Experience with oversight of external Medical Writers and deliverables is required.

Responsabilités

• Guide cross-functional collaborations to develop research, quality and regulatory documents.
• Integrate study information into concise reports and conference materials.
• Lead writing, editing and review of protocols, amendments and clinical study reports for accuracy and compliance.
• Oversee external CROs and ensure timely, high-quality deliverables.

Connaissances

Medical writing

Regulatory knowledge

Attention to detail

Project coordination

Formation

Bachelor’s Degree in scientific/healthcare field

Outils

Microsoft Word

Microsoft SharePoint

Endnote

Adobe Acrobat

Description du poste

Lexicon Pharmaceuticals is seeking a collaborative, agile Senior Medical Writer to join our team in Bridgewater, NJ, The Woodlands, TX, or remotely. The role focuses on producing accurate, compliant documents across R&D, quality and regulatory activities.

The Senior Medical Writer will coordinate cross-functional work, manage external writers, and ensure documentation aligns with Lexicon standards and timelines. A bachelor’s degree and 5+ years of medical writing experience are required.