Medical Writer – Global Clinical Development

Job Description:

• Develop clinical documents including clinical study reports, protocols, informed consent forms, narratives, and investigator brochures
• Manage and facilitate document completion with oversight from Medical Writing leads
• Lead document activities for a compound when assigned
• Drive document development meetings and support timeline execution
• Articulate document strategy and document timelines
• Identify appropriate stakeholders for content decisions and keep discussions progressing
• Synthesize complex discussions into clear, accurate written content
• Collaborate with colleagues and help resolve issues while escalating concerns when needed
• Support timely, compliant document delivery across therapeutic areas
• Collaborate with cross-functional study teams and Medical Writing colleagues

Requirements:

• Bachelor’s degree; advanced degree preferred
• 1 year of relevant experience
• Awareness of the clinical research process and applicable regulations and guidelines
• Scientific and technical reading, writing, and editing skills
• Experience following internal standards, procedures, templates, and peer-review practices
• Knowledge of guidelines, templates, and standard operating procedures for Medical Writing documents
• Working knowledge of Microsoft Word, Adobe Acrobat, and PowerPoint
• Familiarity with electronic document management systems
• Strong organizational, interpersonal, and communication skills
• Ability to maintain current knowledge of industry standards and complete required training

Benefits:

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Medical, dental, vision, life, and disability insurance benefits
• Paid time off
• Family support benefits
• Reasonable accommodation during the recruitment process where required