[Hiring] Medical Writer - Clinical Regulatory Documentation @Perspective Therapeutics

Role Description

Reporting to the Head of Medical/Regulatory Writing, the Medical Writer – Clinical Regulatory Documentation will be responsible for the preparation and delivery of high-quality, scientifically accurate, and regulatory-compliant clinical/medical documentation to support clinical development and regulatory submissions. This role will collaborate with cross-functional teams to author clinical/regulatory documents, including:

• Protocols
• Clinical study reports (CSRs)
• Investigator brochures (IBs)
• Clinical modules for INDs/CTAs, NDAs/MAAs, and other regulatory documents

Qualifications

• 5-8 years in medical writing within the pharmaceutical, biotechnology, or clinical research industry
• Experience in oncology therapeutic area is highly preferred
• Familiarity with global regulatory requirements for clinical documentation (e.g., FDA, EMA, ICH)
• Strong understanding of clinical trial processes and regulatory submissions
• Ability to manage multiple writing projects simultaneously and meet deadlines
• Minimum of a Bachelor’s degree in a life sciences discipline (e.g., Pharmacology, Pharmaceutical Sciences, Biology, or related field); Master’s or Ph.D. preferred

Requirements

• Excellent written and verbal communication skills
• Experienced with standardized writing templates and regulatory submission management platforms
• Strong understanding of global regulatory requirements for clinical trials and medical documentation
• Exceptional attention to detail and commitment to producing accurate, high-quality documents
• Ability to collaborate effectively with cross-functional teams
• In-depth understanding of clinical research and scientific concepts
• Strong organizational and time management skills
• Ability to proactively identify and address challenges related to document quality

Benefits

• Equal employment opportunities for all employees and applicants
• Prohibition of discrimination and harassment of any type