Remote Senior Medical Writing Lead

Lexicon Pharmaceuticals, Inc.; New Jersey; On-site; USD 140,000 - 170,000; Full time

Job summary

Lexicon Pharmaceuticals is recruiting a Senior Medical Writer to join our team in Bridgewater, NJ, The Woodlands, TX, or remotely. The role supports R&D and Quality & Regulatory by producing accurate, concise, and compliant documents and by acting as a subject matter expert on writing processes and tools.

Responsibilities include coordinating cross‑functional collaborations, integrating data into reports and manuscripts, leading protocol/CSR reviews, overseeing external writers and CROs, and

Qualifications

• Bachelor’s degree in a scientific/healthcare field with writing as a major component.
• Minimum of five years of medical writing experience in CRO, medical communications company, pharmaceutical company or similar setting.
• Knowledge of US drug development and regulatory approval processes.
• Experience authoring publications, protocols, CSRs, non-clinical reports and regulatory documents (IND/NDA modules).
• Experience overseeing external medical writers and CROs.
• Proficiency with MS Word, SharePoint, EndNote and Adobe Acrobat.

Responsibilities

• Coordinate cross-functional collaborations to develop research, quality and regulatory documents.
• Integrate data into concise reports, abstracts, posters and journal manuscripts.
• Lead writing, editing and cross-functional reviews of protocols, amendments and study reports.
• Oversee external writers and CROs and prepare SOWs.
• Ensure documents adhere to Lexicon SOPs, style guides and timelines.

Skills

Medical writing

Regulatory knowledge

Docs authoring

Cross-functional coordination

Writers oversight

MS Word

SharePoint

EndNote

Adobe Acrobat

Education

Bachelor's degree in a scientific/healthcare field

Tools

Microsoft Word

Microsoft SharePoint

EndNote

Adobe Acrobat

Job description

Lexicon Pharmaceuticals is recruiting a Senior Medical Writer to join our team in Bridgewater, NJ, The Woodlands, TX, or remotely. The role supports R&D and Quality & Regulatory by producing accurate, concise, and compliant documents and by acting as a subject matter expert on writing processes and tools.

Responsibilities include coordinating cross‑functional collaborations, integrating data into reports and manuscripts, leading protocol/CSR reviews, overseeing external writers and CROs, and