Senior Medical Writer - Remote, Cross-Functional Reg Docs

Lexicon Pharmaceuticals, Inc.; Bridgewater Township (NJ); À distance; USD 120 000 - 160 000; Plein temps

Résumé du poste

Lexicon Pharmaceuticals, Inc. is seeking a Senior Medical Writer to support R&D and Regulatory activities from Bridgewater, NJ or via remote work. You will coordinate cross-functional teams, integrate data into reports and journal manuscripts, and ensure compliance with Lexicon standards and timelines.

The role requires 5+ years in medical writing, deep knowledge of U.S. drug development processes, and experience managing external writers.

Qualifications

• Minimum of five (5) years of medical writing experience in 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
• Experience authoring publications, protocols, CSRs, and regulatory documents (IND/NDA modules) is preferred

Responsabilités

• Guiding and coordinating cross-functional collaborations to develop research, quality and regulatory documents
• Leading writing, editing, and cross-functional review of clinical protocols, amendments, and clinical study reports
• Overseeing external CROs in authoring Lexicon documents and preparing clear SOWs
• Ensuring Lexicon SOPs and standards are followed and documents are filed securely and version controlled

Connaissances

Medical writing

Regulatory knowledge

Cross-functional collaboration

Formation

Bachelor's Degree in a scientific/healthcare field

AMWA membership and ELS certification (plus)

Outils

Microsoft Word

Microsoft SharePoint

EndNote

Adobe Acrobat

Description du poste

Lexicon Pharmaceuticals, Inc. is seeking a Senior Medical Writer to support R&D and Regulatory activities from Bridgewater, NJ or via remote work. You will coordinate cross-functional teams, integrate data into reports and journal manuscripts, and ensure compliance with Lexicon standards and timelines.

The role requires 5+ years in medical writing, deep knowledge of U.S. drug development processes, and experience managing external writers.