Principal Medical Writer – Clinical Focus

• Independently plan and prepare regulatory documents and medical communications supporting all phases of product development
• Organize, analyze, interpret, and present scientific and statistical information
• Ensure work complies with ICH, other regulatory guidelines, and company document standards
• Lead submission-level sections of complex clinical documents within timeline and budget
• Take responsibility for clarity of purpose and lead others toward common project goals
• Integrate expertise across multiple therapy areas to deliver business successes
• Transfer medical writing knowledge to strengthen organizational capabilities
• Work under the direction of Medical Writing management
• Collaborate with cross-functional internal and external document production teams

• Bachelor’s degree required; science-related field preferred
• Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting
• Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis
• Ability to lead submission-level sections, including Clinical Study Reports, Protocols, Investigator Brochures, Integrated Summary of Safety, and Integrated Summary of Effectiveness
• Broad experience and technical expertise across more than one therapy area
• Advanced knowledge of ICH and related regulatory guidelines
• Excellent written English and keen attention to detail
• Strong interpersonal and communication skills
• Experience with Microsoft Office Suite, including advanced Microsoft Word proficiency
• Driving/travel requirements: 0–10% (national and international)
• Ability to occasionally lift/move up to 25 lbs
• Minimum weekly work hours set in accordance with local regulations

• Remote working
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans
• Flexible, inclusive culture