Associate Director, Medical Writing — Remote Leader

Lexicon Pharmaceuticals, Inc.; The Woodlands (TX); Remote; USD 110,000 - 150,000; Full time

Job summary

Lexicon Pharmaceuticals, Inc. is seeking a collaborative Senior Medical Writer to support the Research and Development Organization and the Quality and Regulatory Organization.

The role focuses on producing accurate, concise, compliant documents and serving as a subject matter expert on processes and tools for organizing, writing and reviewing research, development, quality and regulatory documents. You will coordinate cross-functional teams, integrate data into reports, lead writing and reviews

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, pharma or related setting.
• Knowledge of U.S. drug development and approval processes; experience with preparing regulatory documents.

Responsibilities

• Guide cross-functional collaborations to develop research, quality and regulatory documents.
• Lead writing, editing and cross-functional reviews of protocols, amendments and study reports.
• Oversee external Medical Writers and CROs; manage statements of work.
• Maintain Lexicon style guides and reviewer guides; ensure timely delivery.

Skills

Cross-functional collaboration

Technical writing

Editing

Review processes

Stakeholder coordination

Training material development

Education

Bachelor's degree in scientific/healthcare field

Tools

MS Word

SharePoint

EndNote

Adobe Acrobat

Job description

Lexicon Pharmaceuticals, Inc. is seeking a collaborative Senior Medical Writer to support the Research and Development Organization and the Quality and Regulatory Organization.

The role focuses on producing accurate, concise, compliant documents and serving as a subject matter expert on processes and tools for organizing, writing and reviewing research, development, quality and regulatory documents. You will coordinate cross-functional teams, integrate data into reports, lead writing and reviews