[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