CSR Narrative Writer (Medical Writing)

TL;DR

CSR Narrative Writer (Medical Writing): Writing safety documents and patient CSR narratives for regulatory submissions with an accent on high-quality documentation and compliance with ICH guidelines. Focus on managing the document lifecycle, addressing client comments, and ensuring rigorous regulatory standards for pharmaceutical and biotech industries.

Location: Remote (Malaysia), working US EST shift

Company

Innovative, data-focused CRO supporting pharmaceutical, biotech, and medical device industries with a scientific approach to complex trial data.

What you will do

• Write safety documents and patient CSR narratives intended for submission to regulatory agencies.
• Ensure documents comply with appropriate ICH and regulatory guidelines.
• Manage the document lifecycle, including addressing client comments and managing revisions.
• Interact directly and independently with clients to review deliverables.
• Utilize advanced MS Word techniques to produce high-quality technical documents.
• Follow internal and sponsor processes to ensure excellence in all deliverables.

Requirements

• Must be based in Malaysia.
• Ability to work US EST shift.
• University degree in a scientific, medical, or clinical discipline (Master’s or PhD preferred).
• Minimum 2 years of experience in a regulated scientific, pharmaceutical, biotech, or clinical research environment.
• Experience leading complex CSR narratives projects.
• Strong understanding of ICH guidelines as applied to medical writing for clinical studies.
• Proficiency in Microsoft Word, Adobe Acrobat, and Electronic Document Management systems.

Nice to have

• Background in Oncology.
• Prior medical, narrative, or safety writing experience.

Culture & Benefits

• Opportunity to work at a leading CRO recognized by Global Health & Pharma international awards.
• Global work environment with a footprint across four continents.
• Company known for a high customer satisfaction rating (97%).